i

Abstract of thesis entitled

An evidence-based protocol of massage therapy in neonatal unit to improve

the weight gain of preterm infants

Submitted by

Wong Ka Yin

For the degree of Master of Nursing

at the University of Hong Kong

In July 2016

Slow weight gain of preterm infants is a common problem in the neonatal unit,

which would lead to prolong hospitalization of preterm infant. By an informal

nursing observation in a public hospital in Hong Kong, over 80% of the medically

stable infants in neonatal unit have to continue hospitalization because their body

weight did not reach 2000g yet, which was one of the discharge criteria of the

Special Care Baby Unit. In current nursing practice in Hong Kong, no extra

nursing care will be performed to these medically stable infants to improve the

weight gain. This dissertation aims to evaluate the current evidence on the

effectiveness of massage therapy for improving weight gain of preterm babies in

neonatal unit, assess the transferability and feasibility of an evidence-based

protocol to be implemented in a neonatal unit in a public hospital in Hong Kong

(Hospital A), develop an evidence-based protocol on the massage therapy for

preterm infant in a neonatal unit in Hospital A in order to improve their daily

weight gain and develop an implementation and an evaluation plan of assessing

the effectiveness of this evidence-based protocol.

ii

By searching two electronic databases, which were PubMed and CINAHL Plus,

ten randomized control trials (RCTs) meet the inclusion criteria for this

dissertation and all of them were evaluated by a critical appraisal tool, Scottish

Intercollegiate Guideline Network (SIGN) for their level of evidence. All studies

showed that massage therapy for preterm infants improves their daily weight gain.

The transferability and feasibility of the research findings of these ten RCTs are

evaluated. Their research findings are found to be transferrable and feasible in the

target setting in Hong Kong. A detail implementation plan, which includes

communication plan, pilot study plan and evaluation plan, is developed for the

implementation of the evidence-based guideline of massage therapy in the

neonatal unit in the target setting. All the stakeholders will be addressed in the

communication plan. A pilot study will be conducted before the implementation of

the full-scale program to ensure the protocol is feasible in the target setting. After

the implementation of the full-scale program, all outcomes will be evaluated for

the effectiveness of the protocol, which include daily weight gain of preterm

infants, length of hospitalization of preterm infants, cost of extra manpower,

savings from shortened length of hospitalization and staff’s satisfaction level

towards the proposed massage therapy protocol. The expected benefits of the

iii

proposed innovation include improvement of weight gain and reduced length of

hospitalization of preterm infants.

iv

An evidence-based protocol of massage therapy in neonatal unit to improve

the weight gain of preterm infants

By

Wong Ka Yin

BN(Hons), RN (HK)

A dissertation submitted in partial fulfillment of the requirements for the degree of

Master of Nursing

At the University of Hong Kong

July 2016

v

Declaration

I declare that this thesis represents my own work, except where due

acknowledge is made, and that it has not been previously included in a thesis,

dissertation or report submitted to this University or to any other institution for a

degree, diploma or other qualification.

(Sign):______________________________

WONG KA YIN

July 2016

vi

Acknowledgement

I would like to express my sincere gratitude to my supervisor Dr. Patsy Chau

for her patient guidance and encouragement. Her insightful comments and

suggestions helped me to complete this dissertation. It was my pleasure to have

her as my supervisor in my master study in the University of Hong Kong.

Also, I would like to thank my family, friends and colleagues for their support

over the past two years. I cannot complete my dissertation without their support

and encouragement.

vii

Table of content Abstract…………………………………………………………………………….i

Declaration………………………………………………………………………..iv

Acknowledgements………………………………………………………………..v

Table of Content………………………………………………………..…………vi

Chapter 1: Introduction

1.1 Background……………………………………………………………………1

1.2 Affirming the Need……………………………………………………………4

1.3 Objectives and Significance…………………………………………………...7

1.3.1 Objectives…………………………………………………………………....7

1.3.2 Significance…………………………………………………………..……...7

Chapter 2: Critical Appraisal

2.1 Search and Appraisal Strategies……………………………………………….9

2.1.1 Inclusion criteria…………………………………………………….……….9

2.1.2 Exclusion criteria…………………………………………………………….9

2.1.3 The search strategy………………………………………………….…...…10

2.1.4 Appraisal strategy…………………………………………………………..11

2.2 Results………………………………………………………………………..11

2.3 Table of evidence……………………………………………………………..12

2.3.1 Baseline characteristics of subjects of studies……………………………...12

2.3.2 Interventions………………………………………………………………..12

2.3.3 Appraisal results……………………………………………………………15

2.4 Summary and Synthesis…………………………………………………...…15

2.4.1 Weight gain…………………………………………………………………16

2.4.2 Length of stay………………………………………………………………21

2.4.3 Other outcomes……………………………………………………….……21

2.5 Implication……………………………………………………………...……22

Chapter 3: Implementation Potential and Clinical Guideline

3.1 Transferability………………………………………………………………..23

3.2 Feasibility…………………………………………………………………….26

3.3 Cost/benefit ratio……………………………………………………………..30

3.4 Evidence-Based Practice Guideline………………………………………….32

Chapter 4 – Implementation Plan

4.1 Communication plan…………………………………………………………34

4.2 Pilot study Plan……………………………………………………………….37

4.3 Evaluation Plan…………………………………………………………………..40

4.3.1 Identification of the outcomes………………………………………………..40

4.3.2 Target population and number of clients to be involved…………………….42

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4.3.3 Data analysis…………………………………………………………………..43

4.4 Basis for implementation…………………………………………………...…..44

Chapter 5 – Conclusion……………………………………………………………46

Appendice

Appendix A – Table of the searching result………………………………………..47

Appendix B – PRISMA flowchart………………………………………………….48

Appendix C – Table of evidence……………………………………………………49

Appendix D – SIGN critical appraisal checklist…………………………………...57

Appendix E – Time frame for implementing the innovation……………………...80

Appendix F – Cost and benefits of the innovation………………………………...81

Appendix G – SIGN level of evidence and grading system……………………...83

Appendix H – Evidence-based practice guideline of the innovation………….....84

Appendix I – Massage therapy chart……………………………………………..93

Appendix J – Checklist of infant massage assessment…………………………...94

Appendix K – Questionnaire for assessing level of staff’s satisfaction…………..96

References………………………………………………………………….........97

1

Chapter 1: Introduction

1.1 Background

World Health Organization (WHO) (2012) defines preterm infants as infants

who were born alive with gestational age less than 37 weeks. According to the

Born Too Soon: The Global Action Report on Preterm birth (WHO, 2012), around

15 million preterm infants were born every year, and the trend is rising every year.

A study conducted in a university teaching hospital in Hong Kong showed that

6.5% of the singleton infants were born preterm. (Hui, Lao, Leung, Schaaf&

Sahota, 2014). Due to the advance in technology and improvement in neonatal

care, the survival rate of preterm infants had dramatically increased over the past

decades. (Wilson-Costello, 2007; Saigal& Doyle, 2008). However, the morbidity

of preterm infants is high and it becomes a burden of the health care system.

(Wilson-Costello, 2007; Saigal& Doyle, 2008). There is a need to improve the

nursing care of these preterm infant in order to reduce their morbidity. Moreover,

the immature gastrointestinal system of preterm infants may not be effective

enough to absorb nutrients that they need, in fact, feeding intolerance is very

common among preterm infants and therefore their weight gain is not satisfactory.

Although parental nutrition can be used to provide nutrients and achieve better

2

weight gain, it poses a risk to preterm infant by increasing the risk of infection and

liver failure. (Neu, 2007).

Postnatal growth failure is very common among preterm infant with low birth

weight, the study showed that the average weight gain velocity has a negative

association with the rate of postnatal growth failure of preterm infant. (Horbar et

al., 2015). Therefore, postnatal growth failure can possibly be prevented by

improving the weight gain in preterm infant by the implementation of massage

therapy. Postnatal growth failure is related to poor neurodevelopmental outcome

in preterm infant. (Dusick, Poindexter, Ehrenkranz& Lemons, 2003). Preterm

infants have increased risk of a lot of long-term morbidity including

developmental delay, growth retardation, behavior problem, neurodevelopmental

disability, or even cerebral palsy. (Wilson-Costello, 2007; Saigal& Doyle,

2008).A recent systematic review concluded that consistent evidences from

various observational studies showed that there is a positive relationship between

the postnatal weight gain and neurocognitive outcomes of preterm infant. (Ong et

al., 2015). Massage therapy of preterm infant can reduce their stress level in

neonatal intensive care unit (NICU) (Hernandez-Reif, Diego & Field, 2007), it can

improve the neurodevelopmental outcomes of these infant because repetitive

stress will increase the risk of altered brain development and neurodevelopmental

3

consequences. (Ranger&Grunau, 2014). It is important as there are a lot of

environment stressor in the NICU, which includes sound, light and routine nursing

care, and environmental stressors cause physiological and behavioral stress to

preterm infant, and there is a risk of causing neurological problem. (Peng et al.,

2009; Peng et al. 2010). Increased exposure to the environmental stress in the

NICU may be associated with decrease in brain size and alternation of brain

microstructure, and causing alternation of the neurobehaviour of these preterm

infant. (Smith et al. ,2011).

Massage therapy in preterm infants is proved to have no adverse effect in

various studies if they were performed appropriately. (Livingston et al., 2009;

White-Traut&Goldman, 1988). Massage of preterm infants can increase vagal

activity, which will facilitate food digestion by increasing gastric motility and

digestive hormones.(Diego, Field &Hernandez-Reif, M, 2005; Diego et al., 2007),

another study showed that massage therapy can increase serum level of insulin

and insulin-like growth factor 1, which are responsible for growth in infant (Field

et al., 2008), all these mechanisms may explain the potential of massage therapy

of improving weight gain in preterm infant other than aggressive parental

nutritional support when they received massage therapy.

4

1.2 Affirming the Need

The target setting is a neonatal unit which comprise of both NICU and

specialized care baby unit (SCBU) in Hospital A, serving around 370 preterm

infants a year. There are 12 NICU beds, and over 90% of the infants that require

admission to the NICU are preterm infants. There is a “low birth weight” cubicle

in SCBU, when the preterm infants become medically stable in NICU and have

increased their body weight to at least 1500g, they will be transferred to this

cubicle. The preterm infants that do not require NICU admission will be admitted

to this cubicle directly. All preterm infant in this cubicle will be discharged home

when they are medically stable and their body weight becomes equal to or more

than 2000g. Although some preterm infants are medically stable in NICU, they

take a long time to increase their body weight to 1500g in order to be transferred

to the “low birth weight” cubicle of SCBU. In conclusion, inadequate body weight

was the major reason that prolongs hospitalization of preterm infant.

Shorten the length of hospitalization by massage therapy can reduce their

exposure to environmental stressors, and massage therapy can reduce their stress

level during their hospitalization period to improve neurodevelopmental outcomes.

(Procianoy, Mendes & Silveira, 2010). As the neurodevelopmental outcomes of

preterm infants improve, the burden of the health care system will decrease as less

5

special school or special training program have to be provided for them.

There are a lot of evidences showed that massage therapy can shorten the length

of hospitalization of preterm infant. (Rangey&Sheth, 2014; Mendes&Procianoy,

2008; Gonzalez et al., 2009; Field et al., 1986). The hospitalization cost of preterm

infant is high, especially in the NICU. (John, Nelson, Cliver, Bishnoi&Goldenberg,

2000; Gilbert, Nesbitt&Danielsen, 2003), the hospitals and the health care system

can be benefited if the length of hospitalization of preterm infant decreased.

Decrease the length of hospitalization of preterm infants can reduce workload of

nurses, decrease separation of parents and their babies. Prolonged separation of

mothers and their preterm infants would leads to negative attachment behaviours

with their infants. (Flacking et al., 2012). On the other hand, evidence showed that

breastfeeding will become easier after preterm infants are discharged from

hospitals, therefore shorten hospitalization of preterm infants can facilitate

breastfeeding. (Boucher et al., 2011). Breastfeeding is particularly important for

preterm infants as breast milk can reduce their morbidity. (Furman, Taylor, Minich

& Hack, 2003; Vohr et al., 2006). The NICU environment and “rules” are not

facilitating frequent breastfeeding of preterm infants, because their mothers will

be exhausted from frequent pumping of breast milk and transportation to the

hospitalization every day, which will decrease breast milk production. (Boucher et

6

al., 2011). Limited visiting hours, lack of privacy, noisy environment, strict

feeding schedule in the NICU, limited time for skin-to-skin contact with infants,

which was proved to increase milk supply, will induce stress to the breastfeeding

mother and reduce their milk supply. (Flacking, Ewald, Nyqvist&Starrin, 2006;

Aagaard&Hall, 2008; Benoit&Semenic, 2014; Conde-Agudelo&Diaz-Rossello,

2014; Boucher, Brazal, Graham-Certosini, Carnaghan-Sherrard&Feeley, 2011).

Although there is a recent published systematic review of preterm infant massage

(Badr, Abdallah&Kahale, 2015), this systematic review included journals that

used oil massage as intervention, which is different from the proposed innovation

that use massage therapy only to improve the weight gain of preterm infant. Also,

some recent journals related to preterm infant massage were not included in that

systematic review. Therefore, it is needed to perform a systematic review.

Massage for preterm infant in the neonatal unit is not a routine nursing care in

the neonatal unit in Hospital A. Also, there is no protocol available for infant

massage in Hospital A. Therefore, there is a need to develop an evidence-based

protocol for implementation of preterm infant massage.

7

1.3 Objectives and Significance

1.3.1Objectives

1. To evaluate current evidence on the effectiveness of massage therapy on the

daily weight gain of preterm infant

2. To assess the transferability and feasibility of an evidence-based protocol to be

implemented in a neonatal unit in Hospital A

3. To develop an evidence-based protocol on the massage therapy for preterm

infant in a neonatal unit in Hospital A in order to improve their daily weight

gain

4. To develop an implementation and an evaluation plan of assessing the

effectiveness of this evidence-based protocol on the daily weight gain of

preterm infant in the neonatal unit.

1.3.2 Significance

The major barrier of discharging those medically stable preterm infants is

inadequate body weight. Each year, the target setting has around 370 preterm

infants in the “low birth weight” cubicle were medically stable, but they have to

stay in the hospital just because their body weight did not reached the discharge

criteria. These preterm infants have to stay in hospital for an average of 30 days.

Massage therapy can be a simple intervention for improving weight gain in

8

preterm infants, and reduce their length of hospitalization. As mentioned in the

previous session, shorten the length of hospitalization of preterm infants can

provide more opportunities for their parents to have physical or emotional

interactions with their infants, which will improve the bonding between parents

and infants. (Flacking et al., 2012).

9

Chapter 2: Critical Appraisal

2.1 Search and Appraisal Strategies

In chapter 1, we have affirmed the need of developing an evidence-based

protocol for implementation of preterm infant massage protocol. Therefore, a

systematic review on massage therapy for preterm infant will be performed, the

search and appraisal strategies will be discussed in this section.

2.1.1Inclusion criteria

Studies that include preterm infants who are less than 37 weeks of gestational

age as target group of the studies are included. The interventions of the studies

should be massage therapy with moderate pressure or tactile/kinesthetic

stimulation. The control group of the studies should receive no massage therapy at

all. Weight gain or change in body weight should be one of the outcomes of the

studies. All the studies should be RCTs.

2.1.2Exclusion criteria

Studies will be excluded if the interventions used involve the use of oil during

massage therapy. Studies will be excluded if the target group of the studies include

term infant or infant with maternal substance abuse.

10

2.1.3The search strategy

The search was conducted from September to November 2015. The databases

selected for searching were PubMed and CINAHL Plus. The keywords used for

searching were divided into three categories. The first categories (S1) of keywords

included “massage”, “tactile-kinesthetic stimulation” and “tactile/kinesthetic

stimulation”. The second categories (S2) of keywords included “preterm infant”,

“preterm neonate”, “premature infant” and “premature neonate”. The third

categories (S3) of keywords included “body weight” and “weight gain”. The

keywords in each category were linked with “OR” in the search engine, after that,

the searching results of S1, S2 and S3 were combined by using “AND” in the

search engine. 62 studies were identified after searching in databases, and no

additional studies obtained from reference lists. 59 studies left after excluding the

duplicated literatures, and then the studies were screened by titles and abstracts,

28 studies were excluded as they were not relevant to the topic. The full texts of

the remaining 31 studies were assessed for eligibility, and 10 studies were

included in qualitative synthesis finally. Data of these 10 studies were extracted to

table to evidence which summarizes sample characteristics, various kind of

massage method, massage duration and frequency, outcomes and effect size of

massage therapy .

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2.1.4 Appraisal strategy

A methodology checklist for RCTs which is developed by Scottish

Intercollegiate Guidelines Network (SIGN) (SIGN, 2014) was used as a critical

appraisal tool to determine the quality of the literature. High quality RCT is rated

as 1++, acceptable RCT is rated as 1+ and low quality RCT is rated as 1-.

2.2 Results

The details of the searching results were summarized in Appendix A. The

number of articles obtained from the combined searching result in PubMed and

CINAHL Plus was 55 and 7 respectively, 3 of them were duplicated, so the total

number of articles yielded from the initial search was 59. The detail of the

screening process was summarized in PRISMA flowchart which was attached in

Appendix B.

These 59 articles were screened by titles and abstracts, 31 articles were relevant

to the topic, and 28 articles were excluded. Then full text articles of these 31

articles were assessed for eligibility, only 10 of them were included in the

qualitative synthesis. The reasons for excluding the 21 studies were 18 of them

were not RCT, 2 of them had control group that was different from the inclusion

criteria and 1 of them involved the use of oil during massage therapy. Ten RCTs

were yielded from literature search for generating the table of evidence (Appendix

12

C), which will be discussed in the following session.

2.3 Table of evidence

2.3.1Baseline characteristics of subjects of studies

One RCT (Lee, 2005) was conducted in Korea, one RCT (Ferber et al., 2002)

was conducted in Israel, and the other RCTs were conducted in United States. The

target setting of 4 RCTs were intermediate care unit (Gonzalez et al., 2009; Field

et al., 2008; Scafidi, Field & Schanberg, 1993; Field et al., 1986), while the other

RCTs were conducted in NICU. All of the target groups of the ten RCTs were

medically stable preterm infants who have started feeding. Only one RCT did not

state that whether the subjects were ventilator-dependent or not. (Moyer-Mileur,

Haley, Slater, Beachy & Smith, 2013), the other RCTs excluded

ventilator-dependent infants from their studies.

2.3.2 Interventions

Eight of the other RCTs used the method which was developed by Field et al.

(1986) (Method A) as the massage method. Method A is a massage method that

consists of two tactile stimulation phase with a kinesthetic stimulation phase in

between, the tactile stimulation phase consists of twelve strokes for five areas of

the body when the baby is placed in prone position, which are crown to shoulders,

neck across shoulders, upper back to waist, thigh to foot of both legs and

13

shoulders to hands, while kinesthetic stimulation phase consists of five

one-minute session of six passive or extension movements of arms and legs when

the baby is placed in supine position. (Field et al., 1986). Massaro et al. (2009)

just used one of the tactile stimulation phase of method A as the massage method

in one of the treatment group, and another treatment group used one tactile

stimulation phase and one kinesthetic stimulation phase together as the massage

method. Gonzalez et al. (2009) used Vimala massage as the massage method, this

method was different from method A as it massaged infant from head to toe,

supine to prone position and from the midline of the body to extremities.

Moyer-Mileur et al. (2013) used another massage method that is different from

method A by only six strokes were done for each area instead of twelve strokes in

the tactile stimulation phase, and this method involved the massage of the chest

over the ribcage, which was not included in method A, also, the tactile stimulation

phase will not be repeated after kinesthetic stimulation phase in this method.

The control group of all RCTs was without massage therapy. Parents and nurses

acted as massage providers respectively in two intervention groups. (Ferber et

al.,2002). Only two RCTs involved parents in massage therapy (Gonzalez et al. et

al., 2009; Ferber et al., 2002), the other RCTs used health care professionals

(HCPs) to perform massage therapy. Diego et al. (2005) had two intervention

14

groups which differed by the pressure level of the massage provided to preterm

infants. The other seven RCTs had one treatment group only, and their treatment

group used massage therapy alone as intervention.

The frequency of the massage therapy for preterm infants in four RCTs was

twice per day. (Moyer-Mileur et al., 2013; Gonzalez et al., 2009; Massaro et al.,

2009; Lee, 2005). The frequency of the massage therapy of the other six studies

was three times per day. (Field et al., 1986; Scafidi et al., 1993; Ferber et al., 2002;

Diego et al.,2005; Diego et al., 2007; Field et al., 2008). The duration of each

massage therapy was 20 minutes in one RCT (Moyer-Mileur et al., 2013), and 15

to 20 minutes in another RCT. (Gonzalez et al., 2009). The duration of each

massage therapy was 15 minutes in all of the other eight RCTs.

The intervention period of massage therapy was highly variable among ten

RCTs. The intervention period of five RCTs was 10 days. (Gonzalez et al., 2009;

Lee, 2005; Ferber et al., 2002; Scafidi et al., 1993; Field et al., 1986), and three

RCTs set 5 days as the intervention period. (Field et al., 2008;Diego et al.,2007;

Diego et al., 2005). Moyer-Mileur et al. (2013) set the intervention period as 6

days per week, for a maximum of 4 weeks. Massaro et al. (2009) set the

intervention period started from study entry of the infant until the infant was

discharged from hospital.

15

2.3.3Appraisal results

SIGN checklist was used to determine the level of evidence of the RCT. The

SIGN checklists of various RCTs were attached in Appendix D. Level of evidence

of one RCT is (1++) as it used good randomization and concealment method

(Massaro et al., 2009). The level of evidence of six RCTs are (1+), most of them

mentioned randomization but did not specified the method of randomization, and

they did not mentioned the concealment method.(Field et al., 1986; Scafidi et al.,

1993; Ferber et al.,2002; Diego et al., 2005; Diego et al., 2007;Gonzalez et al.,

2009). Level of evidence of three RCTs are (1-) as they did not mentioned method

of randomization and concealment, and due to high dropout rate (Moyer-Mileur et

al., 2013), small sample size (Lee, 2005) and inadequate data of the number of

subjects allocated to each group. (Field et al., 2008). Blinding of the subjects were

not a major concern as all of the subjects were preterm infants, only three RCTs

provided information of blinding the investigator of the study (Moyer-Mileur et al.,

2013; Gonzalez et al., 2009; Diego et al., 2005), while the other RCTs did not

blinded the investigators or did not provide information on it.

2.4 Summary and synthesis

Weight gain was the common outcome measure among all RCTs. Length of

hospitalization was used as outcome measure in two RCTs. (Gonzalez et al., 2009;

16

Field et al. 1986). Only one RCT used change in serum level of insulin and IGF-1

as outcome measure. (Field et al., 2008).

2.4.1Weight gain

Five RCTs reported that massage therapy increase the mean daily weight gain

of preterm infant with an effect size of 5-10g, all results were statistically

significant. (Field et al.,1986; Ferber et al., 2002; Diego et al., 2007; Gonzalez et

al., 2009; Massaro et al., 2009). Massaro et al., (2009) was a good quality RCT

and the other four RCTs were of acceptable quality. (Field et al.,1986; Ferber et al.,

2002; Diego et al., 2007; Gonzalez et al., 2009). Gonzalez et al. (2009) used

method B as the massage method of the intervention, while the other RCTs used

method A as the massage method of the intervention of their studies. However,

Ferber et al. (2002) reported that the weight gain was only statistically significant

from day 6-11 of the intervention period, also, if the massage was performed by

nurse, the mean daily weight gain was 3.45g more when compared with the group

of infants who received massage therapy performed by their parents. On the other

hand, Massaro et al. (2009) reported that the effect of massage therapy on weight

gain of preterm infants was only significant when the birth weight of the infant

was more than 1 kilogram, also, the result of this RCT showed the mean daily

weight gain was 5g more in the group of infants receiving tactile and kinesthetic

17

stimulation when compared with that receiving tactile stimulation only. Also,

Massaro et al. (2009) showed that the kinesthetic stimulation phase of method A

was the main part of the massage therapy that contributed to the increase in weight

gain of the preterm infant.

Scafidi et al. (1993) and Diego et al. (2005) reported that the massage therapy

can increase the mean daily weight gain of preterm infant by 3g and 4.1g in their

studies respectively. While Diego et al. (2005) reported a statistically significant

increase of 0.7g in the weight gain when light pressure massage was used, such

effect could be regarded as clinically insignificant. These two RCTs are of

acceptable quality.

Field et al. (2008) reported that change in weight gain in the massage group was

18.3g more than that in the control group, but the mean daily weight gain was not

reported in this RCT, also, this study was rated as a low quality RCT. Diego et al.

(2007) also reported massage can improve percentage of daily weight gain of the

preterm infants by 30% when compared with infants in the control group. Field et

al. (1986) reported the daily weight gain per calories of intake per kilogram of

body weight of the infants received massage therapy increased by 0.06g when

compared with those in the control group. Scafidi et al. (1993) used the average

weight gain of the infants in the control group to determine the high weight gainer

18

and low weight gainer in both treatment and control group, the result showed that

the high weight gainer in the treatment group was 30% more than that in the

control group.

Only two RCTs did not have show significant positive effect of massage

therapy to weight gain in preterm infant over the control group (Moyer-Mileur et

al., 2013; Lee, 2005), both of them were rated as low quality RCTs by SIGN

checklist.(SIGN, 2014). Moyer-Mileur et al. (2013) reported that the mean daily

weight gain of infants in massage group was +0.4g compared with infants in

control group, but the significance was not reported. Moyer-Mileur et al. (2013)

used method C as massage method, which was a less common method, to massage

the infant. While Lee (2005) showed a positive effect, the results were not

significant. It could be due to the small sample size as this RCT only recruited 26

infants.

Only two RCTs used massage therapy which was performed by parents as

intervention. (Gonzalez et al.,2009; Ferber et al., 2002), both studies showed that

massage therapy that was performed by parents can improve mean daily weight

gain of preterm infants by 6-8g, but Ferber et al. (2002) reported that the effect on

weight gain was more effective if the massage was performed by trained staffs.

The results of these two RCTs were statistically significant. Four RCTs used

19

massage therapy which was performed by trained nurses as intervention (Field et

al., 1986; Scafidi et al., 1993; Lee, 2005; Massaro et al., 2009), Lee (2005) did not

showed significant result while the other three RCTs showed statistically

significant result. Two RCTs used trained staffs for providing massage therapy to

preterm infants without specifying the qualification of the staffs, their results were

statistically significant. (Ferber et al., 2002; Field et al., 2008). Three RCTs used

massage therapist for providing massage therapy to preterm infants without

specifying the qualification of the staffs, two of them were statistically significant.

(Diego et al., 2005; Diego et al., 2007), while Moyer-Mileur et al. (2013) did not

reported the significance of the result.

All reviewed RCTs used 15 minutes as the duration of each massage session,

except two RCTs used 20 minutes (Moyer-Mileur et al., 2013; Gonzalez et al.,

2009), but they showed similar effect size. The frequency of massage therapy of

three RCTs was twice per day (Lee, 2005; Massaro et al., 2009; Moyer-Mileur et

al., 2013), only Massaro et al. (2009) has statistically significant mean weight gain

of +7.5g. The frequency of massage therapy of the other 7 RCTs was three times

per day, by eliminating a result from a poor quality RCT (Field et al. 2008), the

mean of the weight gain of the remaining 6 RCTs was around +6g. As two out of

three RCTs that used "twice per day" as their frequency of massage therapy did

20

not show significant result in mean daily weight gain of preterm infants (Lee,

2005; Moyer-Mileur et al., 2013) and only one out of seven RCTs that used "three

times per day" as their frequency of massage therapy did not show significant

result in mean daily weight gain of preterm infants, the frequency of massage

therapy should be set as three times per day in order to improve the mean weight

gain of preterm infants more significantly.

The implementation period for the massage therapy for each preterm infant will

be set as 10 days as five selected RCTs used 10 days as their length of

implementation period of massage therapy. (Field et al. ,1986; Scafidi et al., 1993;

Ferber et al., 2002; Lee, 2005, Gonzalez et al., 2009). Three RCTs used 5 days as

their length of implementation period of massage therapy. (Diego et al., 2005;

Diego et al., 2007; Field et al., 2008). Massaro et al. (2009) provided massage

therapy to preterm infants from their time of study entry until they were

discharged. Moyer-Mileur et al. (2013) provided massage therapy to preterm

infants from their time of study entry until they were discharged, for a maximum

of four weeks. Three RCTs of acceptable quality that used 10 days as length of

implementation of massage period showed the highest statistically significant

mean daily weight gain among all selected RCTs. (Field et al., 1986; Ferber et al.,

2002; Gonzalez et al., 2009).

21

2.4.2 Length of stay

Length of hospitalization was reported in two RCTs. (Field et al., 1976;

Gonzalez et al., 2009). Field et al.(1976) and Gonzalez et al. (2009) reported that

massage of preterm infants reduced the length of hospitalization by 6 days and 4

days respectively. The results of these two RCTs were statistically significant.

2.4.3 Other outcomes

Only one RCT reported that massage therapy of preterm infants can increase

the change of serum insulin and IGF-1 level by 0.53µU/mL and 0.39ng/ mL

respectively. (Field et al., 2008). Insulin and IGF-1 promotes growth in preterm

infants.

Although massage therapy for preterm infants had no reported adverse effect

among all selected RCTs, some RCTs included some actions that prevent the

occurrences of adverse effects, these actions include pre-warming hands before

providing massage therapy (Gonzalez et al., 2009, Field et al., 1986, Field et al.,

2008), performing massage therapy in incubator (Gonzalez et al., 2009, Ferber et

al., 2002, Field et al., 1986, Field et al., 2008), and arranging massage therapy one

hour after feeding. (Gonzalez et al., 2009, Diego et al., 2005, Diego et al., 2007,

Lee, 2005). These RCTs are of acceptable quality, except Lee (2005) and Field et

al. (2008) are of poor quality.

22

2.5 Implication

There are sufficient evidences to show that massage therapy performed by

trained nurses with moderate pressure can improve weight gain in preterm infant.

Therefore, there is a need to develop an evidence-based protocol of massage

therapy of preterm infant in the neonatal unit in order to improve the weight gain

and shorten the length of hospitalization of hospitalized preterm infants.

23

Chapter 3: Implementation Potential and Clinical Guideline

3.1 Transferability

The target setting of massage therapy is neonatal unit in Hospital A in Hong

Kong, including NICU and low birth weight cubicle of SCBU. The target

population of massage therapy are medically stable preterm infants who are less

than 37 weeks of gestational age in NICU and SCBU. In Hospital A, there were

around 300 infants admitted to the NICU each year, and 90% of the admitted

infants were born preterm, so around 270 preterm infants were admitted to the

NICU each year. Around 100 preterm infants were admitted to the low birth

weight cubicle of SCBU directly without being admitted to the NICU. Therefore,

the number of preterm infants admitted to the neonatal unit was around 370 per

year. Low birth weight is their common problem. After taking references to the

exclusion criteria as stated in the selected RCTs, infants with major congenital

abnormalities, congenital heart malformations, central nervous system dysfunction

and grade II to IV intraventricular haemorrhage, necrotizing enterocolitis, and

infants that were immunocompromised, HIV-infected, having infections that

require contact isolation, receiving ventilator support, phototherapy, antibiotics

treatment, requiring surgical intervention were also excluded. (Field et al., 1986;

Scafidi et al., 1993; Ferber et al.,2002; Lee, 2005; Diego et al., 2005; Diego et al.,

24

2007; Field et al., 2008; Gonzalez et al., 2009; Massaro et al., 2009;

Moyer-Mileur et al., 2013). These conditions are rare in the target setting,

therefore I assume only 5% of the infants are excluded and the number of preterm

infants benefit from the massage therapy will be 352.

There are 12 NICU beds and 12 beds in the low birth weight cubicle of SCBU.

The occupancy of NICU is usually 90-100% and the occupancy of the low birth

weight cubicle of SCBU is usually 50-70%. The target setting of 4 selected RCTs

were intermediate care unit (Gonzalez et al., 2009; Field et al., 2008; Scafidi et al.,

1993; Field et al., 1986), which was similar to the clinical setting of the low birth

weight cubicle of the SCBU of Hospital A, while the other RCTs were conducted

in NICU. As the clinical settings of the SCBU and NICU in the public hospital in

Hong Kong were comparable to the clinical settings as stated in the selected ten

RCTs, the innovation can be transferred to the target setting in order to promote

weight gain of preterm infant. One RCT used parents as the people who

performed massage therapy to their infants. (Gonzalez et al., 2009). On the other

hand, another RCT had two intervention groups which involved mothers and

staffs in performing massage therapy to preterm infants respectively, this RCT

showed better weight gain in the group of infants that receiving massage therapy

from staffs. The massage therapy will be performed by trained nurses in the NICU

25

and SCBU of Hospital A, three acceptable quality RCTs (Field et al., 1986;

Scafidi et al., 1993) and one good quality RCT(Massaro et al., 2009) used trained

nurses as massage therapy provider to preterm infants showed statistically

significant positive result in mean daily weight gain of preterm infant.

The aim of the proposed intervention was promoting the weight gain of preterm

infants, in order to shorten their length of hospitalization and improve their

neurodevelopmental outcomes. According to the vision of the Hospital Authority,

the health care professionals should provide high quality services to patients to

prevent their length of hospitalization and readmission to the hospital, also, to

maximize their quality of life after discharge. (Hospital Authority, 2016). All of

the studies showed similar philosophy of care by providing massage therapy to

preterm infants to improve their weight gain, and decrease their length of

hospitalization, also, improved weight gain can improve neurodevelopmental

outcomes of preterm infants and allow them to have better quality of life and

possibly reduce their possibility of readmitting to hospital in later life. Hospital

Authority (2012) stated that evidence-based and cost-effective treatment options

should be adopted to improve clinical outcomes. This philosophy of care was

shown in all of the selected studies as massage therapy was evidence-based

intervention to promote weight gain of preterm infants. Therefore, the philosophy

26

of care of massage therapy and the Hospital Authority is the same.

The implementation of the proposed project will take seven months in total,

prepare and present proposal to the NC will take two weeks, form a massage

project team will take two weeks, present proposal to the administrative staffs and

get their approval will take one month, present proposal to the consultant doctor

and senior nursing staffs by NC will take two weeks. After these preparation, a

two-month pilot study will be conducted, which will be divided into three phases.

Phase one includes briefing of the innovation to all nurses and conducting training

sessions to all nurses , phase two is the pilot test and phase three includes pilot test

evaluation and refinement of the protocol. After the pilot study, a full-scale

implementation of the massage therapy protocol will last for two months. Then

evaluation of the implementation of the massage therapy protocol in the target

setting will be conducted, which will take one month. The detail of the time frame

for implementation of this innovation is showed in the appendix E.

3.2 Feasibility

Nurses will be responsible for the implementation of the massage protocol of

preterm infant in the neonatal unit. After receiving training from a Certified Infant

Massage Instructor (CIMI), nurses should have the freedom to perform massage

therapy in the target setting, and nurses have the freedom to terminate any

27

intervention that it considered undesirable for the patients. The pediatricians

should be supportive towards this new innovation as it can improve the weight

gain of the preterm infants and shorten their length of hospitalization, and this

innovation is safe as almost no adverse effect was reported from various studies.

The administrative staffs will support the intervention as there is a NC in the

target setting. She conducted research with the doctors and have initiated many

new evidence-based practice in the neonatal unit with other colleagues, such as

using sucrose solution to relieve neonatal pain during painful procedure. She

always encourages nurses to give recommendations that can improve the nursing

care in the target setting. Therefore, it would not cause friction within the

organization.

In the day time, each NICU nurse had to take care of two stable infants or one

critically ill infant. Also, there are 6 NICU beds in one cubicle, a senior nurse has

to supervise junior nurses in this cubicle and acts as a “runner” to assist the

nursing care of the infants in this cubicle. An extra runner will be available during

day time shift to assist with the nursing care in the NICU and SCBU. In the day

time, two nurses will be responsible for the low birth weight cubicle of the SCBU

in each shift. The implementation of the massage therapy protocol may interfere

with current staff functions in a certain extent. However, as the nurses in the

28

NICU and SCBU are busiest at the infant’s feeding time and 1 hour after the

doctors’ round as they has to implement the new treatment to the infant. The

massage can be arranged between the feeding time of the infants, and before the

doctors’ round, so that the nursing activities will not be interfered. If the case

nurse of the preterm infant in the NICU is busy on performing nursing care or

resuscitating other critically ill infant, the senior nurse who acts as a “runner” in

that NICU cubicle will be responsible for performing the massage therapy to the

preterm infants. If this senior nurse is busy too, the runner of the neonatal unit will

be responsible for performing the massage therapy. The nurses in the low birth

weight cubicle of the SCBU should have plenty of time to perform massage

therapy for preterm infants because there are not much extra nursing care that they

have to provide for the infants except the blood taking round in the early morning,

and the major nursing cares that they have to provide for the infants are changing

diapers and feeding babies only. Nevertheless, the nurses may not be cooperative

as their workload will be increased. Therefore, an extra 15 minutes tea time will

be arranged for the nurses in A and P shift to “compensate” for their extra

workload.

Nurses require training in order to become competent to perform the massage

therapy. There are three registered nurses that have attended CIMI course, all of

29

them are willing to provide training sessions for the other colleagues if they do not

need to use their own time to conduct the training session. Three identical training

sessions on massage therapy for preterm infant will be arranged to allow all the

nurses to have the opportunity to attend at least one of them. The other nurses

have to use their own time to attend the training session. As every nurse in the

paediatric department of Hospital A is required to attend at least 5 pediatric

training sessions that were conducted by the nurses or doctors during non-duty

hours every year in order to fulfill the requirement of the staff development review,

the nurses will be willing to attend the workshop of preterm infant massage by

using their own time, also, the nurse can obtain 1 Continuing Nursing Education

(CNE) point by attending it.

The weight gain of preterm infants is the major indicator of the effectiveness of

the massage therapy. All of the stable NICU infants will be weighted on Thursday

and Sunday, and all of the SCBU infants will be weighted on Tuesday and Friday.

A digital weighing scale will be used to weigh the infant. It is a routine nursing

care so it will not increase the workload of nurses. The weight gain of each

preterm infant receiving massage therapy will be recorded for evaluating the

effectiveness of massage therapy. No extra equipment is needed to perform the

massage therapy. The massage therapy will be performed inside the incubator,

30

which is readily available in the neonatal unit and also, some preterm infants are

already inside the incubator.

3.3 Cost/benefit ratio

There was no adverse effect reported for the preterm infants receiving massage

therapy from various literatures. The massage therapy for preterm infants can

improve their weight gain, and also improve their neurodevelopmental outcomes,

shorten their length of hospitalization and thus facilitating breastfeeding.

(Flacking et al., 2012; Boucher et al., 2011; Dusick et al., 2003). If the massage

therapy is not implementing in the target setting, the weight gain of the stable

preterm infants will be compromised, their neurodevelopmental outcomes will

remain unsatisfactory and their hospitalization period will be prolonged, therefore,

breastfeeding will be hindered and their risk of infection increased. Gonzalez et al.

(2009) and Field et al. (1986) reported that the length of hospitalization can be

shorten by performing massage therapy to preterm infants by 4 and 6 days

respectively, without specifying the length of stay in NICU and SCBU separately.

Therefore, the length of hospitalization can be shorten by around 5 days by

estimation. To be conservative, I assumed that only the length of stay in the SCBU

can be shortened.

31

The nonmaterial costs of implementing the massage therapy for preterm infants

include lower staff morale. It is because the implementation of the massage

therapy protocol increases the workload of nurses. However, the potential

nonmaterial benefits of massage therapy for preterm infants include increased

parents’ satisfaction about our nursing care and improve reputation of the neonatal

unit in Hospital A as massage therapy is not routinely performed for preterm

infants in all public hospital in Hong Kong.

All of the detailed calculation procedures of the cost and saving mentioned

below are listed in the appendix F. The set up cost of the massage therapy includes

the cost of the three training sessions organized by three CIMIs, which is $651.

The operational cost of this massage therapy per year includes the time cost of

nurses who perform massage therapy for all eligible admitted preterm infants and

the cost of 15-minutes tea break for nurses in A shift and P shift. As there are 50

RNs in the target setting and their average hourly salary is $192, the cost of

massage therapy for all preterm infants is calculated by $192 times 3/4 hour times

10 days times 352 infants which is $506,880, while the cost of the 15-minutes tea

break would be 13 nurses times $192 times 1/4 hour times 2 shifts times 365 days

which is $455,520, so the total operational cost is $962,400. As the target setting

will recruit around 10 new nurses every year, a training session of massage

32

therapy will be organized for them, so the maintenance cost of this massage

therapy per year is $217. On average, the length of hospitalization could be

shortened by 5 days by massage therapy (Gonzalez et al.,2009; Field et al., 1986).

As the massage therapy may not be effective for all preterm infants, I assume only

80% of the eligible admitted preterm infants can shorten their hospitalization

period. As the daily cost of an acute bed is $4,910. (Hospital Authority, 2016), the

cost related to prolong hospitalization of preterm infants can be reduced by

$6,913,280 per year by implementing this innovation. In conclusion, the

department can save $5,950,663 in the first year by implementing this massage

protocol for preterm infants in the neonatal unit, and saved $6,861,703 per year in

each of the following years.

3.4 Evidence-Based Practice Guideline

The SIGN guideline is used to classify the grade of recommendation and rate

the level of evidences. (SIGN, 2016). The level of evidence of a RCT is the

highest when it is rated as 1++, followed by 1+, and the lowest level of evidence

is rated as 1-. The highest grade of recommendation is “A”, follows by “B”, “C”

and “D”, where “D” represents the lowest grade of recommendation. In order to

achieve grade “A” recommendation, the evidence must be supported by at least

one meta-analysis, systematic review, or a RCT with level of evidence of 1++, or

33

a body of evidence that directly applicable to the target population that have

consistent result of this recommendation. The evidence-based practice guideline

of massage therapy for preterm infants consists of two parts, which includes

assessment and implementation. Eight out of nine recommendation of the

evidence-based practice guideline of this innovation are graded as grade “A”, and

one of it is graded as grade “B”. The detail of the SIGN grading system is listed in

the appendix G. The evidence-based practice guideline of the massage therapy for

preterm infants is listed in appendix H.

34

Chapter 4 – Implementation Plan

A well designed implementation plan is important for implementing a new

protocol in the target setting, the time frame of the implementation plan is shown

in appendix E. In this chapter, the communication plan of various stakeholders

and detail of the pilot study will be discussed. Also, various outcomes of this study

are identified. The effectiveness of the massage therapy protocol will be also be

evaluated.

4.1 Communication plan

In order to formulate a communication plan, the stakeholders of the protocol

must be identified. For the administrative level, the stakeholders include Chief of

Service (COS), Ward Manager (WM), Departmental Operation Manager (DOM),

Advanced Practice Nurse (APN), Nurse Officer (NO) and NC. The WM, DOM

and COS are responsible for the approval of the new clinical guideline in the ward,

by evaluating the cost and effectiveness of the new intervention. They will

allocate resources for the implementation of new clinical guideline if required.

The NC will be responsible to monitor the quality of the nursing care in the ward,

therefore she has to know there will be a new intervention in the ward. Two NOs

and five APNs are responsible to allocate the human resources in every shift of

duty to balance the workload of nurses. The consultant medical officer will assess

35

the risks and benefits of the massage therapy, and determine whether it can be

performed to preterm infants or not. The frontline staffs, that are the 50 Registered

Nurses (RNs), will be responsible to perform the massage therapy to preterm

infants. Therefore, they are stakeholders too. Also, the parents of the preterm

infants are stakeholders because their infants receive massage therapy.

Firstly, the innovation proposer will present the proposal to the NC about the

rationale, risks, benefits, cost-benefit ratio and resource requirement of the

massage therapy for preterm infant in order to gain her support, it will take around

one week. She always encourages colleagues to introduce some new

evidence-based nursing intervention in the ward and she acted as a leader of any

new evidence-based project in the ward. If she supports the proposed innovation,

the innovation proposer will invite her to be the leader of the massage project

team. Then a massage project team will be formed within one week, which

included 1 NC and 4 RNs, 3 out of the 4 RNs will have the qualification of CIMI.

The NC will act as a leader of the team and the RNs will be responsible to provide

training to the nurses on massage therapy of preterm infants, communication with

stakeholders, data collection, data analysis and evaluation. After getting support

from the NC, the innovation proposer will try to gain approval from the

administrative staffs, which include COS, DOM and WM. It is because they have

36

to be informed for any change in ward routine and nursing intervention, and also

they have the power to allocate resources for the implementation of new

intervention. The innovation proposer will present a well-written proposal to WM

first, and explain the rationale of the massage therapy for preterm infants, risks

and benefits, cost-benefit ratio and resources requirement to her. If WM supports

the massage therapy for preterm infants, the innovation proposer will present the

proposal to DOM, if she supports the massage therapy too, she will discuss with

the COS to gain her approval too. The time required to present the proposal to all

administrative staffs and obtain their approval for implementing the innovation

would be around one month. After that, the NC will present the proposal to the

consultant doctor and senior staffs in the clinical setting, including APNs and NOs

in their regular neonatal team meeting every week in order to facilitate the

implementation of the massage protocol in the ward and get their support, it will

take around two weeks.

There is an around 15 minute’s announcement session at 1400 every day. I will

ask the WM for the approval of using three announcement sessions to conduct a

briefing session of massage therapy for preterm infants to all nurses. In the

briefing session, the need for the implementation of massage therapy for preterm

infants will be emphasized and benefits of the massage therapy will be explained.

37

As there is no public hospital in Hong Kong has started the implementation of

massage therapy for preterm infant, the sense of professionalism of the neonatal

nurses in Hospital A can be increased. The progress of the implementation of the

proposed protocol will be presented in the announcement session once per week in

order to allow the nurses to know how their nursing care can improve the weight

gain of their patients, and then their level job satisfaction level can be increased.

Also, an extra 15-minutes tea time will be arranged for all then nurses in A and P

shift to compensate their workload in order to decrease their resistance towards

the implementation of the massage therapy protocol.

4.2 Pilot study Plan

Before the implementation of the full-scale program of massage therapy in the

ward, a pilot study will be conducted to explore the feasibility of the

implementation of massage therapy for the preterm infants in the ward setting.

The objectives of the pilot study include assessing the feasibility of implementing

the protocol, assessing the nurses’ compliance of the protocol and identifying

potential problem during implementation of the protocol.

A massage therapy chart (Appendix I) will be added to the patients’

documentation if the preterm infant is eligible for massage therapy. The consent

for massage therapy will be obtained from the parents of preterm infants and

38

documented in the massage therapy chart when they become eligible for massage

therapy, the risks and benefits of massage therapy will be explained by case nurse

and an information pamphlet will be given to parents. Six massage protocols and

massage method will be printed and laminated, and then two massage protocols

and massage method will be placed inside each cubicle in order to allow the

nurses to take reference as needed.

The duration of the pilot study will be two months, and it will be divided into

phase 1, phase 2 and phase 3. The first two weeks are considered as a phase 1.

Within these two weeks, three briefing session of the training session and massage

therapy protocol will be made by the nurse consultant (NC) during the daily

announcement session. Poster of the training session will be posted to the nurses’

station and all nurses are required to register for one of the training session. All

nurses should have attended an one hour training session for massage therapy for

preterm infant before the end of the phase 1 of the pilot study. During the phase 2

of the pilot study, nurses will have opportunities to familiarize with the techniques

of massage therapy for preterm infants and the use of massage therapy chart. As

mentioned in chapter 2, the number of estimated patients that will be admitted to

NICU and SCBU will be 270 and 100 per year. Therefore, 33 preterm infants will

be admitted to NICU and 12 preterm infants will be admitted to SCBU within the

39

period of pilot study. I expect that 70% of the admitted preterm infants in the

NICU will become eligible for massage therapy within the period of the pilot

study, therefore, around 30 preterm infants will receive massage therapy within

the period of pilot study. Each preterm infant has to receive massage therapy three

times daily for 10 days. There are 50 nurses in the neonatal unit, each nurse

should have opportunities to perform at least 18 times of massage therapy during

the phase 2 of the pilot study period. The APNs and NOs will assign the three

CIMIs to the “runner” position during each shift of duty, so that they can perform

assessment of the massage therapy for the other nurses to ensure they are able to

perform the massage therapy correctly. All the nurses will be assessed on the

massaging skill for at least one time by one of the CIMIs by using a checklist of

infant massage assessment (Appendix J). This form consists of 10 items, each

nurse has to get at least 8 marks out of 10 in order to pass the assessment,

otherwise, a reassessment is required. Massage therapy charts of all eligible

preterm infants for massage therapy will be evaluated by the 4 RNs for staff

compliance with the implementation of the massage therapy for preterm infants

every week. A self-reported questionnaire (Appendix K) will be distributed to all

nurses, and they have to complete and return it to a collection box by the end of

phase 2 of pilot study. Phase 3 of the pilot study consists of evaluation of the pilot

40

study and refinement of the protocol, which will take around two weeks. All

massage project team members will collect feedback from nurses and their

feedback will be discussed in their regular meeting, which will be held once per

week, in order to improve the logistics of the protocol and solve problems

encountered by nurses during pilot study. The protocol will be revised and

modified according to the collected feedback from nurses.

4.3 Evaluation Plan

In order to evaluate the effectiveness of the proposed protocol in the target

setting, the patient outcome, system outcome and healthcare provider outcome of

the implementation have to be evaluated and the target population and required

sample size have to be identified. The evaluation of the innovation will take one

month.

4.3.1 Identification of the outcomes

The patient outcome includes daily weight gain of preterm infants and their

length of hospitalization. Daily weight gain of preterm infants is the primary

outcome as it was a patient outcome that was used by all the reviewed RCTs. It

can be obtained by subtracting the body weight of the preterm infant before the

whole course of massage therapy by the body weight of the preterm infant after

the whole course of massage therapy, and then divided by 10 days. The body

41

weight of preterm infant is measured by a standardized digital scale. Gram will be

used as the unit. The implementation period of massage therapy for each preterm

infant is 10 days, and various studies evaluated the body weight of the infant right

after the whole course of massage therapy. Therefore, the body weight of the

infant will be measured on day 1 and day 11 during the implementation period and

the daily weight gain will be documented in the massage therapy chart. Length of

hospitalization of preterm infants is the secondary outcome, as the preterm infants

can be benefited if their length of hospitalization shorten. The clerk will be

responsible to calculate the length of hospitalization of each infant. It will be

measured when the infant is discharged from the hospital.

The healthcare provider outcome is the staff satisfaction level towards the

massage therapy protocol. Staff satisfaction has a positive relationship with

clinical competency and self-efficacy. (Tyler et al., 2012). A self-reported

questionnaire (Appendix K) will be distributed to all nurses, and they have to

complete and return it to a collection box by the end of the implementation period.

Nurses have to respond to six questions on 5-point Likert scale (Likert, 1932),

ranging from strongly agree to strong disagree, and the total score reflects the staff

satisfaction level towards the massage therapy protocol. 5 marks will be given to

“strongly agree” and 1 mark will be given to “strongly disagree”. The total score

42

will be calculated, ranging from 6 marks to 30 marks, higher score indicates

higher satisfaction level. A total score of 18 indicates overall satisfaction.

The system outcomes are the cost of extra manpower and the savings from

shortened length of hospitalization. Cost of extra manpower includes salary of the

nurses corresponded to performing massage therapy for all preterm infants every

year and the 15 minutes tea break arranged for all nurses in A shift and P shift in

order to compensate for their workload. Saving from shortened length of stay

takes into account the daily costs of hospitalization and the length of hospital stay.

4.3.2 Target population and number of clients to be involved

The target audience of massage therapy is medically stable preterm infants who

are less than 37 weeks of gestational age in NICU and SCBU. The exclusion

criteria include major congenital abnormalities, congenital heart malformations,

central nervous system dysfunction, grade II to IV intraventricular haemorrhage,

necrotizing enterocolitis, immunocompromised, HIV-infected, infections that

require contact isolation, receiving ventilator support, phototherapy, antibiotics

treatment, requiring surgical intervention. (Field et al., 1986; Scafidi et al., 1993;

Ferber et al.,2002; Lee, 2005; Diego et al., 2005; Diego et al., 2007; Field et al.,

2008; Gonzalez et al., 2009; Massaro et al., 2009; Moyer-Mileur et al., 2013).

By taking reference to 7 selected RCTs, the minimal additional daily weight

43

gain of preterm infants after receiving massage therapy is +3g when compared

with the control group. (Field et al., 1986; Scafidi et al., 1993; Ferber et al., 2002;

Diego et al.,2005; Diego et al., 2007; Massaro et al., 2009; Gonzalez et al., 2009).

Three selected RCTs were not included in the calculation as they are low quality

RCTs. (Lee, 2005; Field et al., 2008; Moyer-Mileur et al., 2013). By taking

reference to a RCT that is similar to the ward setting of Hospital A, the standard

deviation of daily weight gain is 6.7g.(Field et al., 1986). A computer software is

used to calculate the required sample size. (Lenth, 2006-9). One sample t-test is

used to calculate the sample size. By setting stigma as 6.7, true mean difference as

3, power as 0.8 and alpha as 0.05 in one-tail paired t test, the sample size required

is 33. To be conservative, I assume the dropout rate of the intervention would be

the highest possible dropout rate among all selected RCTs of good or acceptable

quality, which is 16%. (Diego et al., 2005). Therefore, the final sample size

required is 40.

4.3.3 Data analysis

All analyses will be performed by using Statistical Package for Social Science

(SPSS) version 22 with 5% level of significance. In order to determine whether

massage therapy improve the daily weight gain of preterm infants from day1 to

day 11 of massage therapy by at least 3g more than that in the current setting,

44

t-test will be used. To investigate whether massage therapy can reduce the length

of hospitalization of preterm infants by at least 5 days than that in the current

setting, the length of hospitalization of preterm infants will be analyzed by t-test.

To investigate the staff satisfaction level towards the implementation of the

massage therapy protocol, the percentage of staff with total score of the

questionnaires above 18 will be analyzed by z-test to evaluate if such percentage

exceeds 70% or not.

Cost of extra manpower resulted from performing massage therapy for all

preterm infants will be calculated by the mean hourly salary of nurses, which is

$192,times 15 minutes times 3 times and the number of preterm infants receiving

massage therapy. The cost of the 15-minute break will be calculated by the mean

hourly salary of nurses, which is $192, times 15 minutes times 365 days times the

total number of nurses in A shift and P shift. The savings from shortened length of

hospitalization can be calculated by the daily cost of an acute bed, which is $4,910

(Hospital Authority, 2016) times the number of shortened days of hospitalization.

4.4 Basis for implementation

The minimal additional daily weight gain of preterm infants after receiving

massage therapy is +3g when compared with the control group. (Field et al., 1986;

Scafidi et al., 1993; Ferber et al., 2002; Diego et al.,2005; Diego et al., 2007;

45

Massaro et al., 2009; Gonzalez et al., 2009). The massage therapy protocol is

considered to be effective if preterm infants can achieve an additional daily weight

gain of 3g after the intervention. As the baseline daily weight gain of preterm

infants in Hospital A is 15g, the massage therapy protocol is considered to be

effective if the daily weight gain of preterm infants is equal or more than 18g. The

massage therapy protocol is considered to be effective if the length of

hospitalization can be reduced by 5 days, which is the mean reduction in length of

hospitalization among the selected RCTs. (Gonzalez et al., 2009; Field et al.,

1986).

In order to maintain a positive atmosphere in the ward setting of Hospital A to

facilitate the implementation of the massage therapy protocol, 70% of the

collected questionnaires should be 18 marks or above in order to maintain a

positive atmosphere in the ward setting. Also, in order to increase the feasibility of

the massage therapy protocol, the money saved by the implementation of the

massage therapy protocol should be more than the cost of the extra manpower

required for the implementation of the massage therapy protocol.

46

Chapter 5 - Conclusion

Slow weight gain is a common problem for preterm infants in neonatal unit.

Massage therapy can improve the weight gain of preterm infants with no reported

side effects, and it is a cost-effective intervention which requires no special

equipment to perform. This study adopted a transitional nursing research approach

to propose an evidence-based massage therapy protocol which can guide nurses to

perform massage therapy for preterm infants, in order to improve the weight gain

of preterm infants in the neonatal unit and decrease the length of hospitalization of

preterm infants. Also, the implementation of massage therapy protocol can save

money for the hospital as the cost related to hospitalization of preterm infants can

be reduced.

47

Appendix A - Table of the searching result

Search

ID

Keywords Databases

PubMed CINAHL

Plus

S1 Tactile-kinesthetic stimulation OR

tactile/kinesthetic stimulation OR

Massage

12324 1109

S2 Preterm infant OR Premature infant OR

Preterm neonate OR premature neonate

83485 3762

S3 Weight gain OR Body weight 524088 17344

S4 S1 AND S2 AND S3 55 7

48

Records screened by title

and abstract (n =59)

Appendix B - PRISMA Flow Diagram

Records identified through

database searching (PubMed,

CINAHL Plus)

(n =62)

Additional records identified

through other sources

(n = 0 )

Records after duplicates removed

(n =59)

Records excluded

(n =28)

Full-text articles assessed

for eligibility

(n =31)

Full-text articles excluded,

with reasons

(n =21)

1) Non-RCT: 18

2) Wrong control group: 2

-exercise: 1

-sham therapy: 1

3) Wrong intervention: 1

Studies included in

qualitative synthesis

(n =10)

49

Appendix C- Table of evidence

Citation /

Design

(Study quality)

Sample

characteristics

Intervention Intervent

ion

schedule

Intervention

period

Control

(C)

Outcomes

(Assessment time)

Effect size

(Intervention

- Control)

Moyer-Mileur

et al. (2013)/

United

States/(-)

1. NICU patients

2. GA of

28wks4days

-32wks3days

3. Medically stable

4. Tolerated enteral

feeding volumes

>100 ml/kg/day

-Method C was used

by massage therapist,

which is similar to

method A but it is

shorten and involve

massage of the chest

(n=22)

-Twice

per day

-20

minutes

per

session

6 days per

week, for a

maximum

of 4 weeks

No massage

(n=22)

1. Mean daily weight

gain over 4 weeks

1. +0.4g, NR

Gonzalez et al.

(2009)/

Mexico/ (+)

1. Patients of

neonatal unit

2. Corrected GA of

30 to 35 weeks

3. Clinically stable

without oxygen

supplementation

4. Receive orogastric

feeding

- Method B was used,

which was different

from method A by its

head-to-toe,

supine-to-prone and

midline to peripheral

progression

-Parents were trained

to massage their own

baby.(n=30)

-Twice

per day

-15-20

minutes

per

session

10 days Usual

nursery care

without

massage.

(n=30)

1. Mean daily weight

gain over 10 days

2. Length of

hospitalization

1. +8.3g

(p<0.001)

2.-3.97days

(p=0.03)

50

Massaro,

Hammad,

Jazzo& Aly

(2009)/ United

States/ (++)

1, NICU patients

2.Birth

weight<1500g

and/or

GA≦32wks

3. postnatal

day>7days and

current body

weight>1000g

4. Clinically stable

5. Not on ventilator

support

6. Feed orally

I (A) Massage (Tactile

stimulation phase

only) group (n=19)

-Only the first phase

of method A was

used, the number of

strokes decrease to

six and the time for

each stroke increase

to 10 seconds.

-Massage performed

by trained registered

nurses

I (B) Massage (Tactile

and Kinesthetic

stimulation phases)

group (n=20)

-second phase of

method A was added

after the massage

procedure as stated

above

-Twice

per day

-15

minutes

per

session

From the

time of

study entry

until baby

was

discharged

Standard

care in the

nursery

(n=20)

From the time of

study entry until

discharge,

For all infants

I(A) vs (C)

1. Mean daily weight

gain

I(B) vs (C)

2. Mean daily weight

gain

For infant with

Birth

weight>1000g:

I(A) vs (C)

3. Mean daily

weight gain

I(B) vs I(C)

4. Mean daily

weight gain

1. -1.8g, NS

2. +1.1g, NS

3. +2.5g

(p=0.012)

4. +7.5g

(p=0.012)

51

Field et al.

(2008)/

United

States/ (-)

1. Patients of a step-down

nursery

2. Preterm infant

3. Medically stable, fit for

transfer to the “grower”

nursery, without

respiratory support

-Method A was

used by staffs,

but the

qualification of

staffs is not

specified

(n=21)

-three times

per day

-15 minutes

per session

5 days Usual care

without

massage

(n=21)

At day 5 of the

study,

Primary outcome

1. Change in

insulin (µU/mL)

2. Change in

IGF-1 (ng/ mL)

Secondary

outcome

3. Mean for

change in

weight gain

1. +0.53

(p<0.001)

2. 0.39

(p<0.05)

3. +18.3g

(p<0.02)

Diego et

al. (2007)/

United

States /

(+)

1. NICU patients

2. Preterm infants

3. Receiving gavage

feeding

4. Medically stable

5. Not on ventilator

support

-Method A was

used by massage

therapist

(n=40)

-Three

times per

day

-15-minute

s

sessions

per day

5 days Standard

nursery care

(n=40)

1.Mean daily

weight gain

over 5 days

2. % of daily

weight gain

(g/kg)

1. +5.21g

(p<0.01)

1. +30%

(p<0.05)

52

Lee

(2005)/

Korea/ (-)

1. NICU patients

2. GA<36wks with

birth weight<2000g

3. Not on persistent

mechanical

ventilation

4. Physiologically

stable

-Method A was used

by trained nurses

(n=13)

-Twice per

day

-15 minutes

per session

10 days Usual NICU

care without

massage

(n=13)

1. Mean daily

weight gain over

10 days of

intervention

1) +0.99g, NS

Diego,

Field

&Hernand

ez-Reif

(2005)/

United

States/ (+)

1. NICU patients

2. Preterm infant

3. Medically stable

4. gavage-fed

5. Without respiratory

support

I(A): Massage group

(n=16)

-Method A was used

by massage therapist

I(B): Sham massage

group (n=16)

Followed the same

method as the

massage group, except

that light pressure

stroking was used

during the first and

last 5 minutes periods

of the sham massage.

-Three

times per

day

-15 minutes

per session

5 days Standard

nursery care

(n=16)

I(A) vs (C)

1. Mean daily

weight gain over

5 days

I(B) vs (C)

2. Mean daily

weight gain over

5 days

1. +4.1g

(p<0.01)

2. +0.7g

(p<0.01)

53

Ferber et

al. (2002)

/ Israel /

(+)

1. NICU patients of 3

medical centers

2. GA 26-34 wks

3. Birth weight 600-2200g

4. medically stable without

ventilator support

5. More than 5 days of age

6. Not solely rely on

parenteral nutrition

I(A): Massage by

staff group (n=17)

-Method A was

used, except that

the kinesthetic

stimulation

phase was

removed, the

tactile

stimulation

phase extended

to 15 minutes.

- Staff performed

the massage

I(B): Massage by

mothers group

(n=21)

-Follow the same

massage method

as stated above

-Mother

performed the

massage

-Three

times per

day, at the

beginning

of 3

consecutive

hours

-15 minutes

per session

10 days No massage

was

provided.

(n=19)

I(A) vs (C)

1. Mean daily

weight gain

from day1-5

2. Mean daily

weight gain

from day6-11

3. Mean daily

weight gain

from day1-11

I(B) vs (C)

4. Mean daily

weight gain

from day1-5

5. Mean daily

weight gain

from day6-11

6. Mean daily

weight gain

from day1-11

1. +6.244g, NR

2. +9.1g

(p=0.04)

3. +7.8g

4. +6.38g, NR

5. +5.65g

(p=0.04)

6. +5.98g, NR

54

Scafidi et

al. (1993)/

United

States/ (+)

1. Patients of intermediate

care unit

2. GA=26-36wks

3. Birth weight

=800-1550g

4. Not receiving

intravenous nutrition

5. Entry weight into the

study =1000-1550g

6. Medically stable, in

room air

Method A was

used by trained

research assistant

or nurses. (n=50)

-Three

times per

day, at the

beginning

of 3

consecutive

hours

-15 minutes

per session

10 days Standard

nursery care

(n=43)

1. Mean daily

weight gain

over 10 days

2. Percentage of

high weight

gainers

1. +3g (p<0.01)

2. +30%

(p<0.01)

Field et al.

(1986)/

United

States/ (+)

1. Patients of intermediate

care unit

2. GA<36wks

3. Birth weight<1500g

4. Body weight

1000-1650g when admit

to transitional care

nursery

5. Not on oxygen therapy

6. Not receiving

intravenous nutrition

Method A was

used by nurses.

(n=20)

-Three

times per

day, at the

beginning

of 3

consecutive

hours

-15 minutes

per session

10 days

with 1 day

without

intervention

Routine

nursery care

without

massage.

(n=20)

1. Mean daily

weight gain

over 10 days

2. Mean daily

weight gain

per calories of

intake per

kilogram of

body weight

3. Length of

hospitalization

1. +8g

(p<0.0005)

2. +0.06

(p<0.0005)

3. -6 days

(p<0.05)

Foot notes: GA- Gestational age, NICU – Neonatal Intensive Care Unit, Insulin-Like Growth Factor 1 - IGF-1

NS – non-significant, NR- not reported (significance)

55

Details of massage method

Method A One 15 minutes stimulation session consisted of three 5-minutes phases.

First phase(Tactile stimulation phase)

Baby placed in prone position in an incubator. The person responsible for stimulation performed hand scrubbing,

then she placed the palms of her hands on the infant. Then she gently stroked her hands for five 1-minute periods

(Each stroking motion consisted of 12 strokes at around 5 seconds) over the following area

1) From the top of the head to the neck

2) From the neck across the shoulders

3) From the upper back to the waist

4) From the thigh to the foot to the thigh on both legs

5) From the shoulders to the hands, then from the hands to the shoulders on both arms

Second phase (Kinesthetic stimulation phase)

Baby placed in supine position. This kinesthetic stimulation phase consisted of five 1-minute segments of six

passive flexion or extension movements, starting from the each arm, then each leg, and then both legs together,

with each movement lasted for 10 seconds each.

Third phase

Tactile stimulation phase as stated in first phase was repeated while the baby was placed in prone position

Method B Vimala massage was performed by massaging 6 anatomic regions, including face, upper limbs, thorax, abdomen,

lower limbs and back, and then stretching all four limbs. If infant showed any signs of discomfort noted during

massage, the massage motion slowed down to allow the infant to adapt slowly.

56

Method C Six compression strokes were done to each of the following area

1) Top of thighs to ankles and feet

2) chest over the ribcage

3) Shoulders down to the arms and palms

4) Head from crown to neck

5) From the back of the neck to the waist

After the massage, range of motion was performed by assisting the infant to do extension and flexion movements

over four limbs, 5 times per limb.

Appendix D –SIGN critical appraisal checklist

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages

Field, T. M., Schanberg, S. M., Scafidi, F., Bauer, C. R., Vega

Tactile/kinesthetic stimulation effects on preterm neonates.

Guideline topic:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question

Section 1: Internal validity

In a well conducted RCT study…

1.1 The study addresses an appropriate and clearly

focused question.

1.2 The assignment of subjects to treatment groups

is randomised.

1.3 An adequate concealment method is used.

1.4 The design keeps subjects and investigators

‘blind’ about treatment allocation.

SIGN critical appraisal checklist

Checklist 2: Controlled Trials

Include author, title, year of publication, journal title, pages

Field, T. M., Schanberg, S. M., Scafidi, F., Bauer, C. R., Vega-Lahr, N., Garcia, R., ...& Kuhn, C. M. (1986).

stimulation effects on preterm neonates. Pediatrics, 77(5), 654-658.

Key Question No:

completing this checklist, consider:

randomised controlled trial or a controlled clinical trial? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question � 2. Other reason �

Does this study do it?

The study addresses an appropriate and clearly Yes

“The purpose of the present study was to

evaluate the effects of tactile/kinesthetic

stimulation on weight gain of very small,

preterm neonates who had received intensive

care.“

The assignment of subjects to treatment groups Can’t say

-Stratified randomization based on gestational age,

birth weight, number of NICU days and transitional

care nursery admission weight was done.

-No method of randomization is stated.

An adequate concealment method is used. No

-No method of concealment

is mentioned

The design keeps subjects and investigators

‘blind’ about treatment allocation.

Can’t say

-The study just mentioned the researchers who

conducted the sleep/wake behavior observation

and the Brazelton assessments were blind

group assignments

-No information for blinding is provided for

nurses who provide treatment and measure

body weight

57

Include author, title, year of publication, journal title, pages)

Lahr, N., Garcia, R., ...& Kuhn, C. M. (1986).

658.

Key Question No: Reviewer:

? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

� (please specify):

“The purpose of the present study was to

tactile/kinesthetic

stimulation on weight gain of very small,

preterm neonates who had received intensive

Stratified randomization based on gestational age,

birth weight, number of NICU days and transitional

care nursery admission weight was done.

No method of randomization is stated.

concealment

The study just mentioned the researchers who

conducted the sleep/wake behavior observation

and the Brazelton assessments were blind to the

No information for blinding is provided for

nurses who provide treatment and measure

58

1.5 The treatment and control groups are similar at

the start of the trial.

Yes

1.6 The only difference between groups is the

treatment under investigation.

Yes

1.7 All relevant outcomes are measured in a

standard, valid and reliable way.

Yes

-Daily body weight of infants were measured

1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

0%

1.9 All the subjects are analysed in the groups to

which they were randomly allocated (often

referred to as intention to treat analysis).

Yes

1.10 Where the study is carried out at more than one

site, results are comparable for all sites.

Does not apply

Section 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)☑

Low quality (-)�

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain that

the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes.

-The subjects of this study is preterm infant.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and

the extent to which it answers your question and mention any areas of uncertainty raised above.

Randomization is mentioned but the method of performing randomization is not specified. Also, no

method of concealment is reported in the study. These would downgrade the study. However, this study

was published in 1986, it is acceptable that the method of randomization and concealment was not

mentioned in the study.

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title,

Scafidi, F. A., Field, T., &Schanberg, S. M. (1993). Factors that predict which preterm infants benefit most from

massage therapy. Journal of Developmental & Behavioral Pediatrics

Guideline topic:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question

Section 1: Internal validity

In a well conducted RCT study…

1.1 The study addresses an appropriate and clearly

focused question.

Note:

1.2 The assignment of subjects to treatment groups

is randomised.

1.3 An adequate concealment method is used.

1.4 The design keeps subjects and

‘blind’ about treatment allocation.

1.5 The treatment and control groups are similar at

the start of the trial.

1.6 The only difference between groups is the

treatment under investigation.

Methodology Checklist 2: Controlled Trials

Include author, title, year of publication, journal title, pages

Scafidi, F. A., Field, T., &Schanberg, S. M. (1993). Factors that predict which preterm infants benefit most from

Journal of Developmental & Behavioral Pediatrics, 14(3), 176-180.

Key Question No:

completing this checklist, consider:

randomised controlled trial or a controlled clinical trial? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question � 2. Other reason �

Does this study do it?

The study addresses an appropriate and clearly Yes

“The present study examined individual differences

to identify infant and clinical characteristics that

would predict maximal weight gain in control

infants and in infants receiving massage therapy. “

The assignment of subjects to treatment groups Can’t say

-Randomized stratification based on gestational

birth weight, duration of NICU care and entry

weight into the study was done

-No method of randomization is mentioned

An adequate concealment method is used. No

-No method of concealment is mentioned

The design keeps subjects and investigators

‘blind’ about treatment allocation.

Can’t say

-The research assistant weighted the infant daily, no

data is provided whether he/she is blinded about the

allocation or not.

The treatment and control groups are similar at Yes

-There is no statistically significant difference for

all perinatal data between the control group and the

intervention group.

The only difference between groups is the

Yes

59

year of publication, journal title, pages)

Scafidi, F. A., Field, T., &Schanberg, S. M. (1993). Factors that predict which preterm infants benefit most from

180.

Key Question No: Reviewer:

? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

� (please specify):

“The present study examined individual differences

clinical characteristics that

would predict maximal weight gain in control

infants and in infants receiving massage therapy. “

Randomized stratification based on gestational age,

birth weight, duration of NICU care and entry

weight into the study was done

No method of randomization is mentioned

No method of concealment is mentioned

The research assistant weighted the infant daily, no

data is provided whether he/she is blinded about the

There is no statistically significant difference for

all perinatal data between the control group and the

60

1.7 All relevant outcomes are measured in a

standard, valid and reliable way.

Yes

-The infants were weighted daily by the research

assistant

1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

0%

1.9 All the subjects are analysed in the groups to

which they were randomly allocated (often

referred to as intention to treat analysis).

Yes

1.10 Where the study is carried out at more than one

site, results are comparable for all sites.

Does not apply

Section 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)☑

Low quality (-)�

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain that

the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes

-All of the subjects in this study is preterm infant.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and

the extent to which it answers your question and mention any areas of uncertainty raised above.

Randomization is mentioned but the method of performing randomization is not specified. Also, no

method of concealment is reported in the study. These would downgrade the study. However, this study

was published in 1993, it is acceptable that the method of randomization and concealment was not

mentioned in the study. Also, the sample size of this study was 93 infants, which was a good sample size

to show the effect of massage therapy.

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages

Ferber, S. G., Kuint, J., Weller, A., Feldman, R., Dollberg, S., Arbel, E., &Kohelet, D. (2002). Massage therapy by

mothers and trained professionals enhances weight gain in

37-45.

Guideline topic:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question

Section 1: Internal validity

In a well conducted RCT study…

1.1 The study addresses an appropriate and clearly

focused question.

1.2 The assignment of subjects to treatment groups

is randomised.

1.3 An adequate concealment method is used.

1.4 The design keeps subjects and

‘blind’ about treatment allocation.

Methodology Checklist 2: Controlled Trials

Include author, title, year of publication, journal title, pages

Ferber, S. G., Kuint, J., Weller, A., Feldman, R., Dollberg, S., Arbel, E., &Kohelet, D. (2002). Massage therapy by

mothers and trained professionals enhances weight gain in preterm infants. Early Human Development

Key Question No:

completing this checklist, consider:

randomised controlled trial or a controlled clinical trial? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question � 2. Other reason �

Does this study do it?

The study addresses an appropriate and clearly Yes

“The aim of the present study was to assess the

effect of massage therapy

members on the weight gain of preterm

during their stay in the NICU.”

The assignment of subjects to treatment groups Can’t say

-A random cluster design was used, infants were

randomly assigned and matched

birth weight and age at study entry

-Randomization is mentioned but method of

randomization is not specified

An adequate concealment method is used. No

No method of concealment mentioned

The design keeps subjects and investigators

‘blind’ about treatment allocation.

No

-Two research assistants, supervised by four senior

neonatologists are blind to the treatment allocation,

they calculated enteral and parenteral

according to body weight.

-Mothers are not blinded to treatment allocation as

they need to perform the intervention

61

Include author, title, year of publication, journal title, pages)

Ferber, S. G., Kuint, J., Weller, A., Feldman, R., Dollberg, S., Arbel, E., &Kohelet, D. (2002). Massage therapy by

Early Human Development, 67(1),

Key Question No: Reviewer:

? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

� (please specify):

“The aim of the present study was to assess the

effect of massage therapy by mothers and staff

members on the weight gain of preterm infants

during their stay in the NICU.”

A random cluster design was used, infants were

randomly assigned and matched for gestational age,

birth weight and age at study entry

Randomization is mentioned but method of

randomization is not specified

No method of concealment mentioned

Two research assistants, supervised by four senior

are blind to the treatment allocation,

they calculated enteral and parenteral nutrition

according to body weight.

Mothers are not blinded to treatment allocation as

they need to perform the intervention

62

1.5 The treatment and control groups are similar at

the start of the trial.

Yes

-The differences between the baseline variables

between the intervention and control group are not

statistically significant

1.6 The only difference between groups is the

treatment under investigation.

Yes

1.7 All relevant outcomes are measured in a

standard, valid and reliable way.

Yes

1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

Only overall dropout rate is reported, which is 7%. The

dropout rate in each group was not specified.

-Reasons for dropout:

1) Parent’s personal reasons

2) Change in infant medical conditions

3) Parents cannot meet the standard required by the

research team when they performed massage for their

babies

1.9 All the subjects are analysed in the groups to

which they were randomly allocated (often

referred to as intention to treat analysis).

Yes

1.10 Where the study is carried out at more than one

site, results are comparable for all sites.

Yes

-The breastfeeding policy, the use of preterm

infant’s formula and the policy of total parenteral

nutrition were similar in 3 centers,

Section 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)☑

Low quality (-)�

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain that

the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes

63

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and

the extent to which it answers your question and mention any areas of uncertainty raised above.

Randomization is mentioned but the method of performing randomization is not specified. Also, no

method of concealment is reported in the study. These would downgrade the study.

None of the mothers in the same room were assigned to different treatment groups, it can minimize the

bias by preventing parents from observing the other treatment performed to other babies in the same care.

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication,

Diego, M. A., Field, T., & Hernandez-

massaged preterm neonates. The Journal of pediatrics

Guideline topic:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES com

Reason for rejection: 1. Paper not relevant to key question

Section 1: Internal validity

In a well conducted RCT study…

1.1 The study addresses an appropriate and

focused question.

1.2 The assignment of subjects to treatment groups

is randomised.

1.3 An adequate concealment method is used.

1.4 The design keeps subjects and investigators

‘blind’ about treatment allocation.

1.5 The treatment and control groups are similar at

the start of the trial.

Methodology Checklist 2: Controlled Trials

Include author, title, year of publication, journal title, pages

-Reif, M. (2005). Vagal activity, gastric motility, and weight gain in

The Journal of pediatrics, 147(1), 50-55.

Key Question No:

pleting this checklist, consider:

randomised controlled trial or a controlled clinical trial? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question � 2. Other reason �

Does this study do it?

The study addresses an appropriate and clearly Yes

“we hypothesized that preterm neonates receiving

moderate-pressure massage therapy would

show greater weight gain and increased vagal

activity and gastric motility, but not greater

intake than preterm neonates

light-pressure stimulation (sham/ placebo

or controls.”

The assignment of subjects to treatment groups Yes

-Stratified randomization based on birth weight

-Computer-generated randomization is used

adequate concealment method is used. No

No method of concealment is mentioned

The design keeps subjects and investigators

‘blind’ about treatment allocation.

Yes

“Data collection was done by researchers blind to

the neonates’ group assignments.

clinical staff were also blind to the neonates’ group

assignments and to the hypotheses of the study.

Massage therapists were blind to the

the study”

The treatment and control groups are similar at Yes

No statistically significant difference between the

variables of the treatment groups and control group.

64

journal title, pages)

Reif, M. (2005). Vagal activity, gastric motility, and weight gain in

Key Question No: Reviewer:

? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

plete the checklist.

� (please specify):

hypothesized that preterm neonates receiving

pressure massage therapy would

show greater weight gain and increased vagal

activity and gastric motility, but not greater calorie

intake than preterm neonates receiving

pressure stimulation (sham/ placebo massage)

Stratified randomization based on birth weight

generated randomization is used

No method of concealment is mentioned

“Data collection was done by researchers blind to

neonates’ group assignments. Parents and

also blind to the neonates’ group

hypotheses of the study.

Massage therapists were blind to the hypotheses of

No statistically significant difference between the

variables of the treatment groups and control group.

65

1.6 The only difference between groups is the

treatment under investigation.

Yes

1.7 All relevant outcomes are measured in a

standard, valid and reliable way.

Yes

1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

Massage group:11.1%

Sham massage group: 5.9%

Control group: 15.8%

-It is an acceptable dropout rate.

-The reasons for dropout are equipment malfunction

and unstable data.

1.9 All the subjects are analysed in the groups to

which they were randomly allocated (often

referred to as intention to treat analysis).

Yes

1.10 Where the study is carried out at more than one

site, results are comparable for all sites.

Does not apply

Section 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)☑

Low quality (-)�

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain that

the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes

-All of the subjects of this study were preterm infants.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and

the extent to which it answers your question and mention any areas of uncertainty raised above.

Concealment is not mentioned in the study, it downgraded the study. There may be bias for the dropout

infants were excluded from the study because of unstable data, the author did not specified the details of

the unstable data. The total sample size of this study is 48 infants, which is an acceptable sample size.

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages

Lee, H. K. (2005). The effect of infant massage

premature infants. TaehanKanhoHakhoe Chi

Guideline topic:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question

Section 1: Internal validity

In a well conducted RCT study…

1.1 The study addresses an appropriate and clearly

focused question.

1.2 The assignment of subjects to treatment groups

is randomised.

1.3 An adequate concealment method is used.

1.4 The design keeps subjects and investigators

‘blind’ about treatment allocation.

1.5 The treatment and control groups are similar at

the start of the trial.

Note: All of the baseline neonatal characteristi

are similar, there is no statistically significant

difference.

Methodology Checklist 2: Controlled Trials

Include author, title, year of publication, journal title, pages

Lee, H. K. (2005). The effect of infant massage on weight gain, physiological and behavioral responses in

TaehanKanhoHakhoe Chi,35(8), 1451-1460.

Key Question No:

completing this checklist, consider:

randomised controlled trial or a controlled clinical trial? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated

Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question � 2. Other reason �

Does this study do it?

The study addresses an appropriate and clearly Yes

“The purpose of this study was to evaluate the

premature infants’ responses to infant massage

(tactile and kinesthetic stimulation). These

responses measured by weight, physiological (vagal

tone, heart rate, oxygen saturation) and behavioral

responses (behavioral states, motor activities, and

behavioral distress).”

The assignment of subjects to treatment groups Can’t say

-Randomization is mentioned but method not

specified

An adequate concealment method is used. No

-No concealment method is mentioned

subjects and investigators

‘blind’ about treatment allocation.

Can’t say

-The presence of blinding is not mentioned in the

study

The treatment and control groups are similar at

Note: All of the baseline neonatal characteristics

are similar, there is no statistically significant

Yes

66

Include author, title, year of publication, journal title, pages)

on weight gain, physiological and behavioral responses in

Key Question No: Reviewer:

? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

� (please specify):

“The purpose of this study was to evaluate the

premature infants’ responses to infant massage

and kinesthetic stimulation). These

responses measured by weight, physiological (vagal

oxygen saturation) and behavioral

responses (behavioral states, motor activities, and

ation is mentioned but method not

No concealment method is mentioned

The presence of blinding is not mentioned in the

67

1.6 The only difference between groups is the

treatment under investigation.

Yes

-All infants received the amount of usual touch

during NICU care, the treatment group received

massage therapy in addition to these usual touch.

1.7 All relevant outcomes are measured in a

standard, valid and reliable way.

Yes

Nurse weighted the infants in the early morning

every day.

1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

0%

1.9 All the subjects are analysed in the groups to

which they were randomly allocated (often

referred to as intention to treat analysis).

Yes

1.10 Where the study is carried out at more than one

site, results are comparable for all sites.

Does not apply

Section 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)�

Low quality (-)☑

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain that

the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes

All subjects of this study were preterm infants

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and

the extent to which it answers your question and mention any areas of uncertainty raised above.

Randomization is mentioned but the method of performing randomization is not specified. Also, no

method of concealment is reported in the study. These would downgrade the study. Moreover, the sample

size is small, only 26 infants were included in the study,

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages

Diego, M. A., Field, T., Hernandez Rei‐

massage elicits consistent increases in vagal activity and gastric motility that are associated with greater weight

gain. ActaPaediatrica, 96(11), 1588-1591.

Guideline topic:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question

Section 1: Internal validity

In a well conducted RCT study…

1.1 The study addresses an appropriate and clearly

focused question.

1.2 The assignment of subjects to treatment groups

is randomised.

1.3 An adequate concealment method is used.

1.4 The design keeps subjects and investigators

‘blind’ about treatment allocation.

1.5 The treatment and control groups are similar at

the start of the trial.

1.6 The only difference between groups is the

treatment under investigation.

1.7 All relevant outcomes are measured in a

standard, valid and reliable way.

Methodology Checklist 2: Controlled Trials

Include author, title, year of publication, journal title, pages

z Reif, M., Deeds, O., Ascencio, A., &Begert, G. (‐

massage elicits consistent increases in vagal activity and gastric motility that are associated with greater weight

1591.

Key Question No:

completing this checklist, consider:

randomised controlled trial or a controlled clinical trial? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question � 2. Other reason �

Does this study do it?

The study addresses an appropriate and clearly Yes

“To determine whether preterm infant massage

leads to consistent increases in

gastric motility and whether these increases are

associated with greater weight gain.”

The assignment of subjects to treatment groups Can’t say

-Stratified randomization based on birth weight and

days of NICU stay was used

-Method of randomization is not specified

An adequate concealment method is used. No

-No concealment method is mentioned.

The design keeps subjects and investigators

‘blind’ about treatment allocation.

Can’t say

-The presence of blinding is unclear

The treatment and control groups are similar at Yes

No statistically significant differences between the

baseline characteristics between the treatment group

and the control group

difference between groups is the

Yes

All relevant outcomes are measured in a

standard, valid and reliable way.

Yes

68

Include author, title, year of publication, journal title, pages)

rt, G. (2007). Preterm infant ‐

massage elicits consistent increases in vagal activity and gastric motility that are associated with greater weight

Key Question No: Reviewer:

? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

� (please specify):

“To determine whether preterm infant massage

leads to consistent increases in vagal activity and

gastric motility and whether these increases are

associated with greater weight gain.”

Stratified randomization based on birth weight and

was used

Method of randomization is not specified

No concealment method is mentioned.

blinding is unclear

No statistically significant differences between the

baseline characteristics between the treatment group

69

1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

Control group: 15%

Treatment group: 10%

-It is an acceptable dropout rate

- The reasons for dropout are equipment malfunction

and unstable data.

1.9 All the subjects are analysed in the groups to

which they were randomly allocated (often

referred to as intention to treat analysis).

Yes

1.10 Where the study is carried out at more than one

site, results are comparable for all sites.

Does not apply

Section 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)☑

Low quality (-)�

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain that

the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes

-All of the subjects are preterm infants

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and

the extent to which it answers your question and mention any areas of uncertainty raised above.

Randomization is mentioned but the method of performing randomization is not specified. Also, no

method of concealment is reported in the study. These would downgrade the study.

Each infants in the treatment groups were massaged several therapists to ensure that treatment effects were

the result of the treatment protocol and not from any one particular therapist in order to reduce bias. There

may be bias for the dropout infants were excluded from the study because of unstable data, the author did

not specified the details of the unstable data.

The sample size was 80, which was an acceptable sample size.

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages

Field, T., Diego, M., Hernandez-Reif, M., Dieter,

and insulin-like growth factor 1 (IGF-

pediatrics: JDBP, 29(6), 463.

Guideline topic:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). I

Reason for rejection: 1. Paper not relevant to key question

Section 1: Internal validity

In a well conducted RCT study…

1.1 The study addresses an appropriate and clearly

focused question.

1.2 The assignment of subjects to treatment groups

is randomised.

1.3 An adequate concealment method is used.

1.4 The design keeps subjects and investigators

‘blind’ about treatment allocation.

1.5 The treatment and control groups are similar at

the start of the trial.

1.6 The only difference between groups is the

treatment under investigation.

Methodology Checklist 2: Controlled Trials

Include author, title, year of publication, journal title, pages

Reif, M., Dieter, J. N., Kumar, A. M., Schanberg, S., & Kuhn, C. (2008). Insulin

-1) increased in preterm neonates. Journal of developmental and behavioral

Key Question No:

completing this checklist, consider:

randomised controlled trial or a controlled clinical trial? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question � 2. Other reason �

Does this study do it?

appropriate and clearly Yes

“This study examined the effects of massage

therapy on insulin and IGF

of massage therapy, preterm neonates were

expected to show greater weight gain and higher

concentrations of insulin and IGF

who were not massaged.”

The assignment of subjects to treatment groups Can’t say

-Randomization is mentioned but the method is

not specified.

An adequate concealment method is used. No

-No concealment method is mentioned.

The design keeps subjects and investigators

‘blind’ about treatment allocation.

No

-Parents, staffs and researchers were not

blinded to the group assignment.

The treatment and control groups are similar at Yes

-None of the group differences were

statistically significant

The only difference between groups is the

Yes

70

Include author, title, year of publication, journal title, pages)

J. N., Kumar, A. M., Schanberg, S., & Kuhn, C. (2008). Insulin

Journal of developmental and behavioral

Key Question No: Reviewer:

? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

F YES complete the checklist.

� (please specify):

“This study examined the effects of massage

therapy on insulin and IGF-1. Following five days

of massage therapy, preterm neonates were

expected to show greater weight gain and higher

insulin and IGF-1 than neonates

who were not massaged.”

Randomization is mentioned but the method is

concealment method is mentioned.

Parents, staffs and researchers were not

blinded to the group assignment.

None of the group differences were

71

1.7 All relevant outcomes are measured in a

standard, valid and reliable way.

Yes

-The neonates were weighed daily prior to the 8

am feeding.”

1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

-Only the total dropout rate is stated in the study

-The total dropout rate is 6.7%

-Reason of dropout is not specified

1.9 All the subjects are analysed in the groups to

which they were randomly allocated (often

referred to as intention to treat analysis).

Yes

1.10 Where the study is carried out at more than one

site, results are comparable for all sites.

Does not apply

Section 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)�

Low quality (-)☑

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain that

the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes

-All of the subjects were preterm infants.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and

the extent to which it answers your question and mention any areas of uncertainty raised above.

Randomization is mentioned but the method of performing randomization is not specified. Also, no

method of concealment is reported in the study. These would downgrade the study. Only the total sample

size (N=42) is stated, but the number of neonate in each group was not specified. Although blinding is not

possible in this study, the author stated that “any differential special care would likely be given to the

control group infants and result in decreased group differences or a more conservative test of the treatment

effects”. The reason of dropout is not specified, which would cause bias. The mean for change in weight

gain was the secondary outcome of this study.

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages

Massaro, A. N., Hammad, T. A., Jazzo, B., & Aly, H. (2009). Massage with kinesthetic stimulation improves

weight gain in preterm infants. Journal of perinatology

Guideline topic:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question

Section 1: Internal validity

In a well conducted RCT study…

1.1 The study addresses an appropriate and clearly

focused question.

1.2 The assignment of subjects to treatment groups

is randomised.

1.3 An adequate concealment method is used.

1.4 The design keeps subjects and investigators

‘blind’ about treatment allocation.

Methodology Checklist 2: Controlled Trials

author, title, year of publication, journal title, pages

Massaro, A. N., Hammad, T. A., Jazzo, B., & Aly, H. (2009). Massage with kinesthetic stimulation improves

Journal of perinatology, 29(5), 352-357.

Key Question No:

completing this checklist, consider:

randomised controlled trial or a controlled clinical trial? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question � 2. Other reason �

Does this study do it?

The study addresses an appropriate and clearly Yes

“We conducted a randomized controlled clinical

trial to test the hypothesis that infant massage with

or without KS (or exercise)can improve weight gain

and decrease length of hospital stay in

infants.”

The assignment of subjects to treatment groups Yes

-computer-generated random number

sequence was used for randomization

An adequate concealment method is used. Yes

-Treatment allocation was concealed in opaque,

sequentially numbered, sealed envelopes until study

entry

The design keeps subjects and investigators

‘blind’ about treatment allocation.

Can’t say

-All other persons in the NICU were blinded to the

treatment allocation, except the nurses that have to

perform massage

-For the research assistant who performed data

collection, the author did not state whether he/she

was blinded or not.

72

author, title, year of publication, journal title, pages)

Massaro, A. N., Hammad, T. A., Jazzo, B., & Aly, H. (2009). Massage with kinesthetic stimulation improves

Key Question No: Reviewer:

? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

� (please specify):

“We conducted a randomized controlled clinical

hypothesis that infant massage with

or without KS (or exercise)can improve weight gain

and decrease length of hospital stay in preterm

generated random number table

sequence was used for randomization

Treatment allocation was concealed in opaque,

sequentially numbered, sealed envelopes until study

All other persons in the NICU were blinded to the

treatment allocation, except the nurses that have to

For the research assistant who performed data

collection, the author did not state whether he/she

73

1.5 The treatment and control groups are similar at

the start of the trial.

Yes

All of the baseline characteristics have no

statistically significant difference except for the

head circumferences, but head circumferences were

not likely to have any impact on the result.

1.6 The only difference between groups is the

treatment under investigation.

Yes

1.7 All relevant outcomes are measured in a

standard, valid and reliable way.

Yes

-The infants were weighted by the NICU nurse

every day

1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

Massage group: 9.5%

(1 infant was diagnosed with congenital

cytomegalovirus which required contact isolation, 1

infant was diagnosed with congenital hydrocephalus

and have to transferred to another hospital for

neurosurgical intervention)

massage with

exercise group: 0%

Control group: 0%

This rate of dropout is acceptable.

1.9 All the subjects are analysed in the groups to

which they were randomly allocated (often

referred to as intention to treat analysis).

Yes

1.10 Where the study is carried out at more than one

site, results are comparable for all sites.

Does not apply

Section 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)☑

Acceptable (+)�

Low quality (-)�

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain that

the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes

All of the subjects of this study were preterm infants

74

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and

the extent to which it answers your question and mention any areas of uncertainty raised above.

The author did not specified whether the research assistant was blinded to the treatment allocation, it may

be a risk of bias as this research assistant was responsible for data collection. The reasons for the dropout

subjects were reasonable and are not likely to affect the findings of this study.

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages

Gonzalez, A. P., Vasquez-Mendoza, G., García

Romero-Gutierrez, G. (2009). Weight gain in preterm infants following parent

randomized controlled trial. American journal of perinatology

Guideline topic:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question

Section 1: Internal validity

In a well conducted RCT study…

1.1 The study addresses an appropriate and clearly

focused question.

1.2 The assignment of subjects to treatment groups

is randomised.

1.3 An adequate concealment method is used.

1.4 The design keeps subjects and investigators

‘blind’ about treatment allocation.

1.5 The treatment and control groups are similar at

the start of the trial.

Methodology Checklist 2: Controlled Trials

Include author, title, year of publication, journal title, pages

Mendoza, G., García-Vela, A., Guzmán-Ramirez, A., Salazar

Gutierrez, G. (2009). Weight gain in preterm infants following parent-administered Vimala massage: a

American journal of perinatology, 26(4), 247-252.

Key Question No:

completing this checklist, consider:

randomised controlled trial or a controlled clinical trial? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question � 2. Other reason �

Does this study do it?

The study addresses an appropriate and clearly Yes

“Our specific objectives were (1) to monitor weight

gain among preterm infants

massage program; (2) to assess if observed

differences in weightgain impacted hospital stay;

and (3) to assess secondary

neonates receiving massage.”

The assignment of subjects to treatment groups Yes

-table of random numbers is used for randomization

An adequate concealment method is used. Can’t say

-Concealment is mentioned but not described.

The design keeps subjects and investigators

allocation.

Yes

“One investigator trained and supervised

the administration of massage, and a

different investigator, unaware of group assignment,

collected all study data (weight, caloric intake, head

circumference, etc.). Another

unaware of group assignment, conducted the

statistical analysis.”

The treatment and control groups are similar at Yes

-No statistically significant differences between the

treatment groups and the control

75

Include author, title, year of publication, journal title, pages)

Ramirez, A., Salazar-Torres, M., &

administered Vimala massage: a

tion No: Reviewer:

? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

elevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

� (please specify):

“Our specific objectives were (1) to monitor weight

gain among preterm infants with and without a

program; (2) to assess if observed

differences in weightgain impacted hospital stay;

and (3) to assess secondary effects, if any, among

neonates receiving massage.”

of random numbers is used for randomization

Concealment is mentioned but not described.

“One investigator trained and supervised parents on

the administration of massage, and a

different investigator, unaware of group assignment,

collected all study data (weight, caloric intake, head

circumference, etc.). Another investigator, also

of group assignment, conducted the

No statistically significant differences between the

treatment groups and the control group.

76

1.6 The only difference between groups is the

treatment under investigation.

Yes

1.7 All relevant outcomes are measured in a

standard, valid and reliable way.

Yes

“Weight and caloric intake were recorded daily.

Weight was recorded with a digital scale Seca

GMBH &Co. kg model 374 1321009 (Hamburg,

Germany).Infants were weighed at 8:00 hours every

day, 1 hour before the next scheduled feeding.”

1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

0%

1.9 All the subjects are analysed in the groups to

which they were randomly allocated (often

referred to as intention to treat analysis).

Yes

1.10 Where the study is carried out at more than one

site, results are comparable for all sites.

Does not apply

Section 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)☑

Low quality (-)�

Unacceptable – reject 0 �

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain that

the overall effect is due to the study intervention?

Yes

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Yes

-All subjects of this study were preterm infants.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and

the extent to which it answers your question and mention any areas of uncertainty raised above.

Although concealment is mentioned, it is not described in the study. Parents were responsible for the

massage for their infants, and every massage sessions were supervised by trained health care providers to

ensure the massage was performed appropriately, in order to minimize the bias caused by personal

massage preferences.

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages

Moyer-Mileur, L. J., Haley, S., Slater, H., Beachy, J., & Smith, S. L. (2013). Massage improves growth quality by

decreasing body fat deposition in male preterm infants.

Guideline topic:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete

Reason for rejection: 1. Paper not relevant to key question

Section 1: Internal validity

In a well conducted RCT study…

1.1 The study addresses an appropriate and clearly

focused question.

1.2 The assignment of subjects to treatment groups

is randomised.

1.3 An adequate concealment method is used.

Methodology Checklist 2: Controlled Trials

Include author, title, year of publication, journal title, pages

Slater, H., Beachy, J., & Smith, S. L. (2013). Massage improves growth quality by

decreasing body fat deposition in male preterm infants. The Journal of pediatrics, 162

Key Question No:

cklist, consider:

randomised controlled trial or a controlled clinical trial? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question � 2. Other reason �

Does this study do it?

The study addresses an appropriate and clearly Yes

“Therefore, we evaluated weight gain, body fat

deposition, and circulating leptin and adiponectin

levels in preterm infants randomized to receive a

twice daily Massage

program compared with preterm infants randomized

to receive standard NICU care (Control).”

The assignment of subjects to treatment groups Can’t say

-Stratified randomization based on sex was used

-Method for randomization is not specified.

An adequate concealment method is used. No

-No method of concealment is mentioned.

77

Include author, title, year of publication, journal title, pages)

Slater, H., Beachy, J., & Smith, S. L. (2013). Massage improves growth quality by

162(3), 490-495.

Key Question No: Reviewer:

? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled

questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison

the checklist.

� (please specify):

“Therefore, we evaluated weight gain, body fat

deposition, and circulating leptin and adiponectin

levels in preterm infants randomized to receive a

program compared with preterm infants randomized

ndard NICU care (Control).”

Stratified randomization based on sex was used

Method for randomization is not specified.

method of concealment is mentioned.

78

1.4 The design keeps subjects and investigators

‘blind’ about treatment allocation.

Yes

“Treatment was masked with Massage or Control

administered twice daily by licensed massage

therapists”

“Both Massage and Control were administered

behind a privacy screen to maintain ‘masking 'of the

infant’s study assignment to parents and NICU

clinical staff. In addition, study personnel

responsible for anthropometric measurements or

biochemical analyses (the clinical studies

coordinator and two research assistants) were

masked to the infant’s study assignment to

minimize bias during data collection”

1.5 The treatment and control groups are similar at

the start of the trial.

Yes

All of the baseline parameters of both treatment and

control groups were similar

1.6 The only difference between groups is the

treatment under investigation.

Yes

1.7 All relevant outcomes are measured in a

standard, valid and reliable way.

Yes

“Body weight on an electronic infant scale (Air

Shields, Vickers,

OH) was recorded to the nearest g.”

1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

At study week 4,

Massage group: 50%

Control group: 55%

-It is a high dropout rate

-The reason for dropout is not stated in the study

1.9 All the subjects are analysed in the groups to

which they were randomly allocated (often

referred to as intention to treat analysis).

Yes

1.10 Where the study is carried out at more than one

site, results are comparable for all sites.

Does not apply

Section 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)�

Acceptable (+)�

Low quality (-)☑

Unacceptable – reject 0 �

79

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain that

the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes

All subjects of this study were preterm infant.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and

the extent to which it answers your question and mention any areas of uncertainty raised above.

Although the investigators were well blinded for the treatment allocation in this study, method of

randomization and concealment were not specified in this study. Both of them will downgrade the study.

Also, this study have high dropout rate by week 4 of the study period, and the reasons for the subjects

from dropping out were not specified, it would cause bias to the result.

80

Appendix E -Time frame for implementation of the innovation

Month 1 2 3 4 5 6 7

Week 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28

Present proposal to the NC √

Form a massage project team √

Present proposal to the

administrative staffs and get

organization approval

√ √ √ √

NC presents proposal to

consultant doctors and senior

nursing staffs

√ √

Phase 1 of pilot study

Briefing of the innovation to

all nurses and conduct

training sessions to all nurses

√ √

Phase 2 of pilot study

Pilot test

√ √ √ √

Phase 3 of pilot study

Pilot test evaluation and

refinement of the protocol

√ √

Implementation period √ √ √ √ √ √ √ √

Evaluation √ √ √ √

81

Appendix F – Costs and benefits of the innovation

Set up cost

Item Cost

Cost of 3 training

session (By 3

CIMIs)

Average salary of the 3 CIMIs=$38219

Hourly salary of the 3 CIMs=$38219/176hours

=$217

Total cost of the 3 training session by 3 CIMIs

=$217*3

=$651

Operational cost

Item Cost

Cost of massage

therapy performed

by nurses for all

preterm infants

every year

50 RNs in the ward

Each preterm infants received 3 sessions of massage (15mins

each) every day

the implementation period for each preterm infant= 10days

Average monthly salary of all the RNs

=(5 people x $47,143+ 15 people x $38,219+

30 people x $29,295)/50 people

=$33,757

Average hourly salary of all the RNs

=$33,757/176hours

=$192

Cost of the massage therapy for each preterm infant

=$192x(45 minutes /60 minutes)*10 days

=$1,440

Annual cost of the massage therapy for all preterm infants

=$1,440 x 352 infants

=$506,880

15-minutes tea

break for nurses in

A shift and P shift

per year

There are 13 nurses on duty in each shift.

The cost of a 15-minutes tea break in each shift

=13x $192 x (15minutes/60minutes)

=$624

The annual cost of 15-minutes tea break for nurses of A shift

and P shift

=$624 x 2 shifts x 365 days

=$455,520

82

Maintenance cost

Item Cost

Cost of training

session for new

nurses every year

(By CIMI)

Average salary of the 3 CIMIs=$38,219

Hourly salary of the 3 CIMs=$38,219/176hours

=$217

Cost of a training session by a CIMI

=$217

Saving by massage therapy ( Cost of not implementing massage therapy)

Item Cost

Saving by

shortening period

of hospitalization

of preterm infants

Shorten hospitalization period by ~5 days

Assume only 80% of eligible preterm infants can be benefited

from the massage, as some of them may be excluded or not

effective to massage therapy

Saving by shortening period of hospitalization by preterm

infant

=$4,910 x (352 infants*80%) x 5 days

=$6,913,280

Total amount saved by the massage therapy on preterm infants to the ward in the first

year

=$6,913,280-($651+$506,880+$455,520)

=$5,950,229

Total amount saved by the massage therapy on preterm infants to the ward per year

=$6,913,280-($217+$506,880+$455,520)

=$6,861,703

83

Appendix G – SIGN level of evidence and grading system

Level of evidence

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a

very low risk of bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low

risk of bias

1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias

2++ High quality systematic reviews of case control or cohort or studies

High quality case control or cohort studies with a very low risk of

confounding or bias and a high probability that the relationship is causal

2+ Well-conducted case control or cohort studies with a low risk of

confounding or bias and a moderate probability that the relationship is

causal

2- Case control or cohort studies with a high risk of confounding or bias and

a significant risk that the relationship is not causal

3 Non-analytic studies, e.g. case reports, case series

4 Expert opinion

Grading system

Grade A At least one meta-analysis, systematic review, or RCT rated as 1++,

and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+,

directly applicable to the target population, and demonstrating overall

consistency of results

Grade B A body of evidence including studies rated as 2++, directly applicable

to the target population, and demonstrating overall consistency of

results; or

Extrapolated evidence from studies rated as 1++ or 1+

Grade C A body of evidence including studies rated as 2+, directly applicable to

the target population and demonstrating overall consistency of

results; or

Extrapolated evidence from studies rated as 2++

Grade D Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Reference:

Scottish Intercollegiate Guidelines Network (2014). SIGN grading system 1999-2012.

Retrieved 20th February, 2016, from

http://www.sign.ac.uk/guidelines/fulltext/50/annexoldb.html

84

Appendix H- Evidence-Based Practice Guideline

Title

An evidence-based protocol of massage therapy in neonatal unit to improve the

weight gain of preterm infants

Target Users

Registered nurses working in SCBU and NICU

Target population of the proposed protocol

Medically stable preterm infants, with consent from parents

Aim

To improve the weight gain of preterm infants in neonatal unit

Objectives

The objectives of the evidence based guideline were:

1) To prevent growth restriction of preterm infants by improving their weight gain

(2) To provide a standardized evidence-based practice of massage method for preterm

infants

(3) To enhance nurses’ competency on performing massage therapy to preterm infant

85

Recommendations

Part 1 - Asessment

1) Assess the eligibility of the infants to massage therapy

A) The infants should be preterm (less than 37 weeks of gestation), medically

stable, without congenital abnormalities, congenital malformation, feeding

intolerance, conditions that affects central nervous system (Grade of

recommendation: A)

� Supporting evidence

Massage therapy should be provided if the preterm infant was medically stable,

without conditions that may affect weight gain. (Massaro et al., 2009; Field et el.,

1986; Scafidi et al., 1993; Ferber et al., 2002; Diego et al., 2005; Diego et al.,

2007;; Lee, 2005; Field et al., 2008; Gonzalez et al., 2009;Moyer-Mileur et al.,

2013) (1++,1+,1+,1+,1+,1+,1+,1-,1-,1-)

B) The infant which required surgical intervention should be excluded. (Grade of

recommendation: A)

� Supporting evidence

Infant that requires surgical intervention is considered as clinically unstable and

massage therapy should not be performed. (Gonzalez et al., 2009; Diego et al.,

2005; Diego et al., 2007; Lee, 2005; Field et al., 2008) (1+,1+, 1+, 1-, 1-)

86

C) Infants with congenital infection should be excluded. (Grade of

recommendation: A)

� Supporting Evidence

Infants with congenital infection, such as HIV infection, will be more likely to be

immunocompromised and prone to infection during the massage procedure.

(Scafidi et al., 1993; Diego et al., 2005; Diego et al., 2007; Field et al., 2008)

(1+,1+,1+,1-)

D) Infants with maternal substance abuse should be excluded (Grade of

recommendation: A)

� Supporting evidence

Maternal substance abuse, including illicit drugs and alcohol, will cause infants to

be more likely to have growth restriction, which limit the effectiveness of massage

therapy on these infants. (Gonzalez et al., 2009; Field et al., 1986; Scafidi et al.,

1993; Diego et al., 2005; Diego et al., 2007; Field et al., 2008)

(1+,1+,1+,1+,1+,1-)

Part 2 - Implementation

2) The massage method by Field et al. (1986) should be used. This method

included a 15 minutes stimulation session consisted of three 5 minutes phases.

The first and last phase was tactile stimulation phase, while the middle phase

87

was kinesthetic stimulation phase. During the tactile stimulation, the infant

was placed in prone position, and then stroked with his or her hands for five

1 minute period (12 strokes, 5 seconds per stroking motion) over 5 regions of

the infants’ body. The sequence as listed as follow:

(i) From the top of head to the neck

(ii) From the neck to the shoulders

(iii) From the upper back to the waist

(iv) From the thighs to the foots, and then from the foots to the thighs

(v) From the shoulders to the hands, and then from the hands to the shoulders.

During the kinesthetic stimulation phase, the infant was placed in supine position.

Six Passive flexion and extension movements will be performed for each arm,

and then each leg, and finally both legs together, and each movement lasts for

around 10 seconds. (Grade of recommendation: A)

� Supporting evidence

Six studies used massage method that was stated in Field et al. (1986), and this

massage method was showed to be effective in improving the weight gain of

preterm infants in these studies. (Field et al., 1986, Scafidi et al., 1993, Diego et

al., 2005, Diego et al., 2007, Lee, 2005, Field et al., 2008) (1+, 1+, 1+, 1+, 1-, 1-)

88

3. The massage schedule should be three times per day and 15 minutes for each

session. (Grade of recommendation: A)

� Supporting evidence

Three studies used this massage schedule in their research and found to be

effective in improving the weight gain of preterm infants in these studies.. (Field

et al., 1986, Scafidi et al., 1993, Ferber et al., 2002). (1+, 1+, 1+)

4. The massage should be arranged one hour after previous feed. (Grade of

recommendation: A)

� Supporting evidence

Four studies suggested that the massage should be arranged one hour after

previous feed to avoid the infant from vomiting. (Gonzalez et al., 2009, Diego et

al., 2005, Diego et al., 2007, Lee, 2005) (1+, 1+, 1+, 1-)

5. The massage procedure should be performed inside the incubator. (Grade of

recommendation: A)

� Supporting evidence

Four studies suggested that the massage should be performed inside the incubator

to maintain the temperature of the infant throughout the massage procedure.

(Gonzalez et al., 2009, Ferber et al., 2002, Field et al., 1986, Field et al., 2008) (1+.

1+, 1+, 1-)

89

6. The nurse should prewarm his or her hands by thorough hand scrubbing

before performing the massage to the preterm infant. (Grade of

recommendation: B)

� Supporting evidence

Three studies recommended the person who is responsible to massage the infant to

prewarm his or her hands before performing the massage, in order to maintain the

body temperature and avoid causing discomfort to the infant. (Gonzalez et al.,

2009, Field et al., 1986, Field et al., 2008) (1+, 1+, 1-)

7. Moderate pressure should be used to perform the massage therapy for

preterm infant. (Grade of recommendation: A)

� Supporting evidence

Four studies recommended the massage therapy should be performed by using

moderate pressure as moderate-pressure massage therapy may increase vagal

activity and gastric motility which leads to better weight gain. (Scafidi et al., 1993,

Ferber et al., 2002, Diego et al, 2005, Field et al. ,2008) (1+, 1+, 1+, 1-). Also, the

effect size resulted from light pressure massage is clinically insignificant. (Diego

et al., 2005).

90

8. The nurse should observe whether the infants have any sign of discomfort (e.g.

back arching, clenched fists, crying) throughout the massage procedure, if it

lasts for more than 15 seconds, the nurse should slow down the massage

action without breaking skin contact with the infant to allow the infant to

adapt to it. (Grade of recommendation: B)

� Supporting evidence

The sign of discomfort of the infant should be observed by nurse throughout the

massage procedure to avoid overstimulation of the infant. (Gonzalez et al., 2009)

(1+)

9. No oil or cream should be used during the massage procedure for the preterm

infants. (Grade of recommendation: A)

� Supporting evidence

All studies did not use oil or cream during the massage procedure for preterm

infants. (Massaro et al., 2009, Field et al., 1986, Scafidi et al., 1993, Ferber et al.,

2002, Diego et al., 2005, Diego et al., 2007, Lee, 2005; Field et al., 2008,

Gonzalez et al., 2009,Moyer-Mileur et al., 2013.) (1++, 1+, 1+, 1+, 1+, 1+, 1+,

1-, 1-, 1-)

91

References

Field, T. M., Schanberg, S. M., Scafidi, F., Bauer, C. R., Vega-Lahr, N., Garcia,

R., ...& Kuhn, C. M. (1986). Tactile/kinesthetic stimulation effects on preterm

neonates. Pediatrics, 77(5), 654-658.

Scafidi, F. A., Field, T., &Schanberg, S. M. (1993). Factors that predict which preterm

infants benefit most from massage therapy. Journal of Developmental &

Behavioral Pediatrics, 14(3), 176-180.

Ferber, S. G., Kuint, J., Weller, A., Feldman, R., Dollberg, S., Arbel, E., &Kohelet, D.

(2002). Massage therapy by mothers and trained professionals enhances weight

gain in preterm infants. Early Human Development, 67(1), 37-45.

Lee, H. K. (2005). The effect of infant massage on weight gain, physiological and

behavioral responses in premature infants. TaehanKanhoHakhoe Chi,35(8),

1451-1460.

Diego, M. A., Field, T., & Hernandez-Reif, M. (2005). Vagal activity, gastric motility,

and weight gain in massaged preterm neonates. The Journal of

pediatrics, 147(1), 50-55.

Diego, M. A., Field, T., Hernandez Reif, M., Deeds, O., Ascencio, A., &Begert, G. ‐

(2007). Preterm infant massage elicits consistent increases in vagal activity and

gastric motility that are associated with greater weight

92

gain. ActaPaediatrica, 96(11), 1588-1591.

Field, T., Diego, M., Hernandez-Reif, M., Dieter, J. N., Kumar, A. M., Schanberg, S.,

& Kuhn, C. (2008). Insulin and insulin-like growth factor 1 (IGF-1) increased

in preterm neonates. Journal of developmental and behavioral pediatrics:

JDBP, 29(6), 463.

Massaro, A. N., Hammad, T. A., Jazzo, B., & Aly, H. (2009). Massage with

kinesthetic stimulation improves weight gain in preterm infants. Journal of

perinatology, 29(5), 352-357.

Gonzalez, A. P., Vasquez-Mendoza, G., García-Vela, A., Guzmán-Ramirez, A.,

Salazar-Torres, M., & Romero-Gutierrez, G. (2009). Weight gain in preterm

infants following parent-administered Vimala massage: a randomized controlled

trial. American journal of perinatology, 26(4), 247-252.

Moyer-Mileur, L. J., Haley, S., Slater, H., Beachy, J., & Smith, S. L. (2013). Massage

improves growth quality by decreasing body fat deposition in male preterm

infants. The Journal of pediatrics, 162(3), 490-495.

93

Appendix I - Massage therapy chart

The informed consent for massage therapy was obtained from mother/father/parents

on ______________ by _______________(Staffs’ name & Signature)

Become eligible for massage therapy when:

Day of life: _______________

Gestational age: ________________(At birth) � __________________ (Now)

Body weight: _______________ (At birth) � __________________(Now)

Basic information:

Feeding pattern: Q2Hx10/Q3Hx8 On TPN infusion: Yes/No

Mode of ventilation: RA/NC/HHHFNC/NIV-CPAP

Day Date Adverse event (e.g. sign of distress,

desaturation, bradycardia)

Performed by

(signature)

1

2

3

4

5

6

7

8

9

10

Please fill in the body weight of the infants on day 1 and day 11 of massage therapy

protocol

Day 1 Day 11

Body weight (g)

Daily weight gain (g)

Patient’s Gum label

94

Appendix J –Checklist of infant massage assessment

Name: _________________

Item Pass Fail Remarks

1) Perform hand hygiene before performing

massage

2) Pre-warm his or her hands by thorough

hand scrubbing before performing the

massage

Tactile stimulation phase

2) Infant is placed in prone position

3) Stroked with his or her hands for five 1

minute period over 5 regions of the

infants’ body in correct sequence:

(i) From the top of head to the neck

(ii) From the neck to the shoulders

(iii) From the upper back to the waist

(iv) From the thighs to the foots, and then

from the foots to the thighs

(v) From the shoulders to the hands, and

then from the hands to the shoulders.

4) For each region of the infants’ body,

perform 12 strokes and each stroking

motion lasts for around 5 seconds

Kinesthetic stimulation phase

5) Infant is placed in supine position

6) Six Passive flexion and extension

movements will be performed for each

arm, and then each leg, and finally both

legs together, and each movement lasts

for around 10 seconds

Tactile stimulation phase

7) Infant is placed in prone position

8) Stroked with his or her hands for five 1

minute period over 5 regions of the

infants’ body in correct sequence:

(i) From the top of head to the neck

(ii) From the neck to the shoulders

(iii) From the upper back to the waist

95

(iv) From the thighs to the foots, and then

from the foots to the thighs

(v) From the shoulders to the hands, and

then from the hands to the shoulders.

9) For each region of the infants’ body,

perform 12 strokes and each stroking

motion lasts for around 5 seconds

General assessment

10) Moderate pressure is used throughout

the massage procedure

Assessor: ____________________

Marks: ______/10 (If <8, the nurse has to be reassessed again by CIMI)

96

Appendix K - Questionnaire for the evidence-based protocol of massage therapy

Please circle the best answer

on the right side

Strongly

agree

Agree Neutral Disagre

e

Strongly

disagree

The length of the training

session is appropriate

5 4 3 2 1

The training session is useful

for learning how to perform

massage therapy in preterm

infant

5 4 3 2 1

The workload is affordable 5 4 3 2 1

The massage therapy chart is

easy to use

5 4 3 2 1

The routine nursing care is not

affected by the massage

therapy protocol

5 4 3 2 1

Overall, you are satisfied with

the massage therapy protocol

in preterm infants

5 4 3 2 1

Please feel free to write down any comment related to the implementation of massage

therapy protocol for preterm infants:

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