The Effect of Music-Reinforced Nonnutritive Sucking on State of Preterm, Low Birthweight Infants Experiencing Heelstick

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Joumal of Music Therapy. XLV 3), 200B, 227^2 72© 2008 by Ihe American Music Therapy Association

The Effect of Music-Reinforced

Nonnutritive Sucking on State of Preterm,Low Birthweight InfantsExperiencing Heelstick

Jennifer Whipple PhD MT -BC NICU-M TCharleston Southern University

This study exam ined the physiologic and behavioral effectsof music-reinforced nonnutritive sucking (NN S) for preterm,iow birthweight (LBW ) infants experienc ing heelstick. Sub-jects were 60 infants, age 32 to 37 we eks post conceptionalage in a neonatal intensive care unit. Infants were random lyassigned to one of three treatmen t groups: pacifier-activatedlullaby (PAL), pacifier-oniy, and no-contact. Experimen talinfants vt ere p rovided the Sondrex® PAL S ystem , whichplays music contingent on infant sucking. Pacifier-oniyinfants did not receive music reinforcement for sucking,

and no-contact infants were not provided a pacifier or m usicat any point during the procedure. Stress level and behav iorstate were assessed continuously and heart respiratory, andoxygen saturation rates were recorded at 15-secondinten/ais for all infants. Most physiologic data results wereinconclusive. How ever, analysis of behavior state and stresslevel revealed the following significant differences for thePAL and pacifier-only groups compared to the no-contactgroup, a il of w hich were greatest between the PAL and no-contact groups : iower during-hee istick behavior statemeans, less time in undesirabie behavior states, lowerduring- and post-heelstick stress level means, and smallerbehavior state and stress levei differences between inten/ais.In addition, the PAL group had a significantly lower pre-heelstick stress level mea n than the no-contact group.Behavior state and stress ievei were also more stable acrosstime for the PAL group than the other groups, and patterns

This study was partially funded by Ohm eda Medical, a subsidiary of GeneralElectric.

This manuscript is based on the author s dissertation completed at the Rorida



Joumal of Music Therapy

of changes in oxygen saturation behavior state and stresslevel indicate that music-reinforced NN S may facilitate returnto hom eostasis.

Review of LiteratureNeon atal Intensive are

Pretenn infants arc known to be at high-risk for manifestationof sensory, motor, aud cognitive deficits later in childhood, as they

exhibit greater incidence of all disabilities than the generalpopula tion of fullterm infants (Parm elee, Beckwith, Cohen, &:Sigman, 1983), whether directly caused by premature birth orrelated to inappropriate stimulation during the newborn period(Duffy, Als, & McAnult>, 1990). The first goal of neonatalintensive care is infant stirvival. Consequently, medical interven-tion is the primary initial foctis. s a result, the environment of theNeonatal Intensive Care Unit (NICU) may interfere with thematuration and organization of the infant's central nervotissystem and fail to meet the infant's developmental needs (White-Trau t, Nelson, Burns, & Cunningham , 1994). Infant neurologicdevelopment is cephalocaudal and proximodistal, manifested ininitially more ftilly developed receptors oí tactile and vestibularstimulation than those of hearing and vision (Owens, 2001). Thenature of the NICU can overstimulate the lesser developeddistance receptors through contintial presence of bright lightsand noxious sounds, and neglect the more mature tactile andvestibular pathways (White-Traut et al., 1994). Also potentiallydisrupting to the infant's growth and development are thenecessary caregiving and medical procedures (Duffy et al., 1990).

Barker and Rutter (1995) studied the pattern of invasiveprocedures performed from admission to discharge for 54 infants,76 of which were bom preterm, admitted consecutively to anNICU over a period of three months. A total of 3283 procedureswere reco rded, w th 74 of those performed for infants bombefore 31 weeks gestation. The most procedures performed for asingle infant numbered 488 for a female born at 23 weeksgestation. The most frequently performed procedure was blood



Vol. XLV No. 3. Fall 2008 229

suctioning (26 ), followed by peripheral venous canuula

insertion (8 ). O ther procedures perfonn ed were venous hloodsample; intubation; intramuscular injection; insertion of venouslong line, peripheral arterial line, and umhilical catheter; arterialstab; lumbar puncture; chest drainage; and suprapubic aspiration.

Investigations suggest that preterm neonates have increasedsensitivity to pain and that acute painful stimuli lead todevelopment of prolonged periods of increased pain sensitivity.In addition, acute physiologic changes caused by painful orstressful stimuli have heen implicated as factors in the develop-

ment or extension of intraventricular hemorrhage (IVH), andischémie changes leading to periventricular leukomalacia (PVL),while therapeutic interventions thai provide comfort or analgesiain preterm infants have been correlated with decreased incidenceof severe IVH (Anand, 1998). Further, while infants may notconsciously remember events, they may develop proceduralmemory that can lead to abnormal behavioral patterns or alteredsensory processing in later life. Early damage can lead toprolonged structural and functional alterations in pain pathwaysthat can last into adult life (Anand, 2000) and such changes canpromote increased anxiety, altered pain sensitivity, stress disor-ders, and hyperactivity and attention disorders, leading toimpaired social skills and patterns of self-destructive behavior(Anand & Scalzo, 2000).

Neonatal Pain ssessment

Because pain responses are multidimensional, it seems that

pain measurement in preterm infants should also be multidi-mensional. Researchers generally evaluate pain responses usingchemical, behavioral, and physiologic means (Dyke, 1993). Whilemost infants display concordant reactions between behavioral andautonomie responses, some show opposite responses with onemeasure high and another measure low (Morison, Grünau,Oberlander & Whitfield, 2001). In term newborns, the painstimulus response tends to mimic the stress response of adults,though there is insufficient research regaiding chemical respons-es (e.g., alterations in salivary cortisol) in preterm infants (Dyke,1993).



3 ournal of Mu sic Therapy

alterations in sleep-wake cycles Dyke, 1993). For exam ple,

Grünau, Holsti, Whitfield, and Ling 2000) observed in very lowbirthweight VLBW), preterm infants that changes in slee p /waking state, facial brow raising, finger .splay, and leg extension, aswell as the physiologic measure of heart rate HR) weresignificandy related to experience of procedures that would beconsidered to cause distress i.e., endotracheal suctioning, chestphysiotherapy, diapering, and gavage feeding). F tirther, John ston,Sherrard , et al. 1999) positively correlated cry duration with painscores of preterm infants experiencing heelstick procedures.

hysiologic responses Physiologic responses can include increasedHR and blood pressure BP), the presence of palmar sweating,increased intracranial pressure, varying transcutaneous oxygentension TcPO.^), increased respiratory rate RR), decreased vagaltone , decreased oxygen saturation SaO2), and the presence o fagalvanic skin response. For example, HR, RR, and SaOy ofpreterm infants experiencing rou tine painful procedures i.e.,injection, heelstick, squeezing of the heel to induce blood flow,and tape removal) and nonpainful procedures that could stillinduce stress in a high-risk infant i.e., han dling , tem peratu remeasurement, alcohol swabbing, patting, taping a tube, feeding,and pacifier insertion) have been measured to be significantlydifferent between pre-, during-, and post-procedure intenals, withHR and RR significantly higher and SaOg significantly lowerduring painful procedures than during those considered to benonpainful Gonsalves Sc Mercer, 1993).

Measuring variability in physiologic variables is another, and

possibly more effective, method of evaluating pain. Historically,studies have considered HR reactivity as a unidimensionalmeasure that increases with a painful stimulus, typically increasingimmediately following the noxious stimulus, and declining duringthe recovery period. Like all homeostatic functions, greaterincreases and decreases in HR are considered to indicate healthand maturity, since organized patterns of phy.siologic measurescan denote increased capacity of the infant to respond tochanging environmental demands. Consequently, quantificationof variability in HR patterns may provide a measure of changes inautonomie and CNS activity that reflect behavior responses of the



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The comparison of low and high frequencies is considered the

preferred method for obtaining measures of HR variability(HRV), yet this method is complex and standard deviationsinstead can provide some HRV information (Oberlander : Saul,2002).

Regardless, all physiologic ind icators of pain and distress shouldbe considered in light of normal parameters. Infant HR should bebetween 100 and 200 beats per minute or not greater than 20over baseline. Changes in HR paired with irritability should alsobe monitored as should changes in HR that occur along with SaOg

below 86 . Respiratoi7 rate should n()t exceed 20 over baselineand episodes of apnea paired with bradycardia or oxygendesaturation are considered to be outside of normal parameters.Finally, SaOg of 86 or greater is within normal limits, tbough allgradual, consistent desaturation should be monitored (Burns,Cunningham, White-Traut, Silvestri, : Nelson, 1994).

actors nfluencing Neona tal Pain Responses

Several factors may influence physiologic pain responses,including behavior state (Oberländer, Grünau, Fitzgerald, &Wbitfield, 2002; Oberlander Saul, 2002), gestational age at birtliand time of intervention (Johnston, Stevens, Yang, et al., 1996;Oberlander Saul, 2002), and frequency and intensity of medicalor caregiving procedures (Oberlander et al., 2002). Infants closeto term age display smaller HR increases in response to invasiveprocedures tban those born prem aturely (Oberländer &: Saul,2002) and also demonstrate smaller HR increases even when

studied at tbe same post conceptional age (PCA) (Johnston,Stevens, Yang, et al., 1996). It also seems that behavioralimmaturity may be associated with greater frequency of invasiveprocedures, wbile birth factors are associated with physiologicimmaturity (Johnston & Stevens, 1996). Based on bebavioralresponses to heelstick procedures, preterm infants who spendPCA weeks 28 through 32 in an NICU are less mature in painresponses than newborn prem ature infants born at 32 weeks.Furtber, based on observed changes across time, it appears that

infants who experience frequent heelstick procedures may learnto anticipate the painful stimulus (Goubet, Clifton, & Shah ,



oumal of f\ lusic Therapy

gestation to nursing and medical procedures tends to increase

with rising level of procedural invasiveness, demonstrating thatintensity of procedure may also influence infant pain re-sponses Porter, Wolf, Miller, 1999). Also, some hehavioraland physiologic pain response. may be more evident duringpainful procedures when infants have been handled not longbefore the procedure. Porter, Wolf, and Miller 1998) found thatinfants who were handled prior to a baseline period as if they werebeing prepared for a lumbar puncture procedure displayedhigher mean HR, greater behavioral arousal, and more facial

activity dunng a subsequent heelstick procedure than did thenon-handled infants. In addition, Grünau et al. 2000) foundfacial brow raising to he significantly related to the number ofinvasive procedures an infant had experienced within theprevious 24 hours. i . . .

harmacologie Neonatal Pain Management

Untreated pain in infants is associated with increased major

morbidity and mortality Anand, 1998, 2000; Menon, Anand, Mclntosh, 1998). Choice of pharmacologie intervention tomanage pain in neonates is based largely on the type of pain.Antipyretic analgesics like ace tam inophen Tylenol®) may assistin managing inflammatory pain, though intravenous (IV) opiatestend to be the primary pharmacologie form of analgesia used withneonates Menon et al., 1998). Sedatives including benzodiazi-pines and barbituates may also be used Mainous. 1995).

Analgesics While necessary, the use of analgesia du ring the firstfew days of life is complicated by prematurity and critical illnesses van Lingen, Simons, Anderson, Sc Tibboel, 2002). Accuracy indosing is challenging since many drugs are not recommended hythe manufacturer or have not been tested for neonates and thetoxic dose for some infants may be the desirable dose for others.In addition, the use of opioid analgesics e.g., m orp hin e fentanyl) in neonates may present dangers such as negativecardiovascular effects and convulsions Mainous, 1995). Further,use of pharmacologie pain management may inhibit some painindicators, as behavioral and physiologic responses are moredifficult to assess in the presence of mechanical ventilation,



Vol. XLV No. 3 Fall 2008 33

Stability, decreased incidence of advanced IVH in pre term infants

receiving ventilator assistance, and better behavioral and cognitiveoutcomes at long-term follow-up (van Lingen et al., 2002).Sedatives Sedative agents can facilitate physiologic stability in

the presence of less acutely painful stimuli or when opiates woitldproduce adverse effects (Menon et ah, 1998). However, sedativesalso present dangers, such as dependence; possible increased riskof IVH; and gastric mucosa irritation, which is a challenge forpremature infants already at risk for feeding intolerance. Further,sedation for relief of pain without analgesia is rarely acceptable;however, certain analgesics aud sedatives are interactive andaddictive and require close monitoring of infant respiration(Mainous, 1995).

Local anesthesia and topical treatment Local anesthesia of skin an dmucous membranes, such as with Eutectic Mixture of LocalAnesthetic (EMLA). can be beneficial for infants experiencinginvasive procedures (Menon et al., 1998), with diminishedphysiologic and behavioral responses during circumcision docu-mented for infants who received EMLA com pared to tho.se who didnot. Such treatment may also diminish pain responses duringvenipuncture, arterial ptincture, and percu taneous venous catheterplacem ent (Taddio, Ohisson, Einarson, Stevens, Koren, 1998).However, EMLA has not been shown to diminish heelstick pain(Mclntosh, van Veen, Brameyer, 1994; Taddio et al., 1998), likelybecause the components of the mixture cause vasoconstriction thatreduce blood flow and lead to more painful squeezing of the heelto obtain adequate blood samples (Mclntosh et al., 1994).

Role of Developm ental Intervention

A variety of interventions for premature infants, often fromopposing theoretical bases, yield similar results (Feldman 8cEidelman, 1998), and the type of intervention may be lessimportant than its influence in promoting homeostasis (Dieter cEmory, 1997). The NICU should not only assure survival btit alsosupport infant developmental progression (Blickman, Brown, Als,Lawhon, c Gibes, 1990) through environmental, caregiving, andpain reduction practices. Environmental adaptations includeshielding from overhead lights and noise (.\ls 8c Duffy, 1989;



4 oumal of Music Therapy

1997). Since reduction of noxious stimuli can improve oxygénation

of hlood and thereby reduce need for supplemental oxygen andventilator support, method and timing of all sensory input,including medical and caregiving procedures, m ust be considered(Blickman et al., 1990). Caregiving practices of staff and parents toreduce infant pain and stress responses can incltide positioning,sleep state regulation pro tection (Als Duffy, 1989), soothingmusic or touch, containment or rocking, spring-loaded lances forheelsticks, analgesics during stressful procedures (Modrein-McCarthy et al., 1997), and nonnutritive sucking (NNS) (Als

Dufïy, 1989; Modrein-McCarthy et al., 1997). Intervention shouldbe tailored to the infant's autonomie, motor, and state behaviors,and stability should be monitored so that continual modificationsto eare may he made (Modrein-MeCaithy e t al., 1997).

The use of such adaptations has resulted in documentation ofthe following medical and netirodevelopmental henefits forpremattire, VLBW infants:

• earlier normalization of feeding behaviors;

• reduction in du ration of mechanical ventilation andstipplemental oxygen support (Als c Duffy, 1989; Als etai., 1986; Als et al., 1994; Blickman et al, 1990) andincidence of IVH, bronchopiilmonary dysplasia (BPD), andpneumotho rax (Als Duffy, 1989; Als et al., 1994);

• increase in daily weight gain (Als et al., 1994) and decreasein length of hospitalization and related expenses; (Als et al.,1994; Als Dufïy, 1989); and

• hetter psychomotor, motor, verbal, memory, and cognitioncapabilities throughout childhood (Als et al., 1986; Als et al.,1994; Als c Cilkerson, 1997; Blickman et al., 1990).

Nonnutritive sucking A form of neonatal interven tion oftenincorporated into individualized caregiving is provision of NNS.The earliest compon ents of sucking behaviors have been observedin the fetus beginning around 7 or 8 weeks PCA. Oral and gagreflexes first appear between 2 and 6 weeks and sucking appearsby 24 weeks. Sucking and swallowing are present by 28 weeks, but

are not fully coo rdinated until a round 32 to 34 weeks PCA (Pinelli Symington, 2003). Th e following benefits of NNS have been



Vol. XLV No. 3 Fail 2008 23 5

• increased TcPO j (Shiao, Chang, Lannon, Yarandi, 1997)

and relationships in TcPO'¿ levels among pre-sucking,sucking, and post-sucking intervals, indicating that NNSmay facilitate optimal oxygénation (Burroughs, Asonye,Anderson-Shanklin, Sc Vidyasagar, 1978);

• decreased HR, suggesting that NNS reduces energy expen-ditvire and possibly explaining why NNS has been shown toenhance preterm infant giowlh (Shiao et al., 1997;Woodson Ham ilton, 1988); and

• reduced length of hospitalization (Pinelli 8c Symington,2000, 2008).

onphajinacologic Neonatal Pain Management

Sensory stimulation Given the cumulative nature of stimtilationand hypersensitivity of preterm infants, touch in the form ofstroking during painful procedures can increase infant stressrather than serve as a soothing intervention. Beaver (1987) fotmdthat stroking the infant's leg during a heelstick procedure was

more aversive to preterm infants than the painful procedurealone, as evidenced by a greater change in physiologic measuresfrom the baseline period.

Yet music may be beneficial for preterm infants dtiring noxiousprocedures. Burke, Walsh, Oehler, and Gingras (1995) reportedresults from four case studies of preterm infants with BPDundergoing suctioning, which has been shown to be a stress-producing inten'ention for neonates. For these infants, thepresentation of music in the form of recorded intratiterine

sounds blended with synthesized female voices for 15 minutesfollowing suctioning resulted in reduced level of arousalcompared to no intervention, and more time spent sleeping thanwithout music or with vibrotactile stimulation. Also, Bult andKisilevsky (2000) demonstrated that, in preterm infants older than31 weeks PCA, the presentation of piano and a cappella voicerecordings of a lullaby affected more rapid ret\nn of HR,beha\'ioral state, and facial expressions of pain to baseline levelsfollowing heelstick procedures.

Nonnu tritive sucking and sucrose Field and Goldson (1984)investigated the effects of NNS on behavior state and cardiac




gestational age and clinical stability, those infants who were given

pacifiers spent significantly m ore time in alert and quiescent statesand less time in fussing and crying states during and afterheeisticks. Results suggested that NNS during heelstick proce-dures may diminish behavioral distress in all neonates regardlessof gestational age. Similarly, Miller and A nderson (1994)discovered that infants receiving assisted mechanical ventilationcried significantly less, had lower HRs during IV catheterinsertion, and had significantly smaller HR increases frombaseline to post-cry when provided opportunities for NNS.

Another method of nonpharmacologic pain management forneonates is the use of sucrose with and without NNS. The calmingand pain-relieving effects of sucrose are thought to be mediatedby endogenous opioid pathways activated by sweet taste (Gibbins Stevens, 2001). Stevens, Yamada, and Ohlsson (2003) complet-ed a re\'iew of the use of orally administered sucrose as analgesiain hospitalized term and preterm neonates, finding that sucrosedecreased HR, citing, facial activity, and pain scores in infantsexperiencing heelstick or venipuncture.

Opposite of sucrose, the analgesic effects of S are thought tobe activated through nonopioid pathways by stimulation oforotactile and mechanoreceptor mechanisms. Because combiningNNS and sucrose involves opioid and nonopioid pathways as wellas orogustatory- and oro tactile-induced analgesia, the combina-tion offers the most potent nonpharmacologic intervention. Thiscombination is still not sufficient for managing severe pain, but itcan be incorporated with other pharmacologie and nonpharma-

cologic interventions to create multi-faceted pain-relieving strat-egies (Ramenghi, Evans, c Levene, 1999)

Music Therapy Intervention fo r Preterm nfants

Results of a meta-analysis ofthe efficacy of music in interventionfor premature infants completed by Standley (2002) revealed aneffect size of 0.83, indicating benefits of almost a full standarddeviation greater than had no intervention been implemented.Results were not differentiated based on PC^ at time ofintervention, birtbweight, or method of music presentation. Theuse of music alone or combined with other types of stimulation



Vol. XLV No. 3 Fall 2008 \ .- 37

increased rates of NNS and feeding, weight gain, and SaO-i*.

decreased HR; and behavior state modulation. usi listening Music listening alone hy ho.spitalized prematureinfants has resulted in decreased iniiial weight loss and observedstress behaviors (C-aine, 1991), increased weight gain (Malloy,1979 , improved SaO^ (Cassidy 8c Standley, 1995; Standley 8cMoore, 1995), decreased HR and RR (Cassidy Standley, 1995),and less crying at 6 months after hospital discharge (Standley,1991 . In fact, Cassidy and Standley (1995) found no contraindi-cations for music during the first week of life as early as 24 weeks

gestation, thcmgh sensory stimulation, including auditory stimula-tion, is often restricted for those very young and clinically tinstahleinfants, such as those with chest tubes or receiving certain types ofassisted ventilation. In some situations, music li.stening may providethe most beneficial type of stimulation, yet, depending on infantage and stability, implementation of modifit^d auditory, tactile,visual, and ve.stibular stimulation procedures, whether simplifiedfor younger infants or with greater complexity to encourageinteraction for more mature infants, could be developmentallyappropriate (Abromeit, 2003; Wliipple, 2005).

Music ranforc£d nonnutritive sucking. A meta-analysis of studiesregarding the effects of music as reinforcement for subjectsranging in age from 2 days to 24 years revealed that the use ofcontingent music alone or when paired with nonmusic stimuli wasmore elective than non-contingent music and contingentnonmusic stimuli (Standley, 1996). A separate meta-analysis ofstudies utilizing contingent music specifically for infant learning,

with infants ranging from 34 weeks PC^ to 8 months of age,indicated that contingent music had a positive and significantimpact (Standley, 2001).

Supported by these results, Standley (2000) developed thepacifier-acüvated hillaby system to reinforce NNS. The system wasfound to significantly increase sucking frequency of preterminfants as young as 32 weeks PCA, with mean PCA of 35.5 weeks,when reinforced with lO-second intervals of a recording of awoman singing lullabies. In an average of 2.5 minutes, infantslearned to suck frequently enough for music to be playedcontinuously, and sucking rates during contingent music were




sucking rate, an important aspect of the suck-swallow-breathe

coordination necessary for independent feeding. The same systemwas used by Standley 1999) to assess transfer of increased suckingrates to feeding behaviors. Baseline evening bottle-feeding rateswere lower than morning bottie-feeding rates for preterm infantsaged approximately 36 weeks PCA who were referred for servicesdue to delays in ind ependent feeding. For infants who received anopportunity for approximately 15 minutes of music-reinforcedNNS from 30 minutes to one hour prior to evening bottie-feeding, mean evening feeding rate was significantly increased

from morning rate, while evening rate mean for control infantswas somewhat decreased from the morning rate.

Documentation of these benefits led to development byHealing Health Systems of the Sondrex® Pacifier ActivatedLullaby PAL) System®. The PAL system, designed to teachpacing and endurance of sucking necessary for nipple feeding,plays mtisic contingen t on infant sucking. A wired o r wirelesstransm itter connected to a pacifier sends a signal to the Sondrex®Sound CD System and the infant is rewarded with music, providedhe or she generates a certain threshold of sucking pressure. TheP system also has the capability to play continuous music withor without the u.se of the pacifier and transmitter. The device hasreceived approval as a mechanism to facilitate poor feedingbehaviors from the United States Food and Drug Administration.

The purpose oí this study was to examine the effects of music-reinforced NNS using the Sondrex® PAL System® on painresponses of preterm, LBW infants experiencing a painfulprocedure, specifically blood collection via heelstick. Physiologicand behavioral measures for infants provided the PAL werecompared to those for infants provided only a pacifier and thosewho received no intervention beyond standard care.

Method uiêcts and etting

Subjects TV = 60) were prete rm born prior to 37 weeksgestation, based on estimated date of con finem ent), LBW bornweighing less than 2500 g) infants, hospitalized in an NICU,



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• < 32 weeks PCA at the time of study participation;

• >: 37 weeks PCA at the time of study participation;• cleft palate, cleft lip, or oth er oral anom alies;• diagnosed grade 3 or 4 IVH, hydrocephalus, or PVL;• size too small or too large for th e Wee Soothie®

(recommended weight of 3 to 5 pounds) or Soothie® ( ^5 pounds) pacifier as determined hy nursing staff

• ventilator assistance al the time of study par ticipation.

Subject identification and group assignment did not control for

gestational age or clinical stability of infants beyond the abovelisted inclusion and exclusion criteria. Infants were randomlydivided into one experimental and two conüol groups totaling 20infants each, evenly divided between males and females. Infor-mation was recorded from infant medical charts regarding weightand gestational age at birth and at the time of study participation,medical and developmental assessments, diagnoses, and interven-tions. Birthweight was not recorded for one male in the no-contact group. Acuity Score, a measure of infant clinical stability,was recorded on the day of study participation; an Acuity Scorewas not available for 3 infants (pacifier-only: male, female; no-contact: 1 male). The Acuity Score incorporates the followingfactors: feeding behaviors; bedding (i.e., open warmer, incubator,or open crib); requirem ent for oxygen, card io respiratory monitor,and pulse oximetry; use of heat lamp or phototherapy; medica-tions and tubing, including IV lines; additional care requirem ents,such as suctioning, circumcision, or ostomy care; and behaviorstate and responses to caregiving. Higher Acuity Scores indicatelower infant clinical stability.

All demographic and treatment variables were analyzed using aOne-way Analysis of Variance (ANOVA) test with an alpha level of.05. Also compared were the duration of the heelstick procedureand, for the experimental and pacifier-only control groups, theduration of sucking hefore the heelstick procedure hegan and forthe pre-, during-, and post-heelstick intei vals com bined . Suckingduration was defined as the length of time during which an infantwas offered a pacifier, regardless of the presence of actual sucking,measured from the time the pacifier was initially placed in the




The same demographic variables were examined for a subset of

40 infants for whom an additional physiologic variable of SaO2was available for analysis. The SaO.2 sample included 14 infants (7male, 7 female) in the experim ental group , 13 pacifier-oniyinfants (7 male, 6 female), and 13 no-contact infants (4 male, 9female). Of the infants mentioned above for whom Acuity Scorewas no t available, the pacifierKinly female and the no-conlact m alewere SaO^ Subjects. Using a one-way ANOVA, a significantdifference was found among treatment groups for Acuity Score, { 35), p ^ .04. Examination of group means revealed that the

experimenta l group had the lowest Acuity Score (or highest clinicalstability); however, post hoc analysis using Tukey's honestlysignificant difference (HSD) showed that the contrast indicateddoes not appear to be for any of the three pairs. Therefore, contrasttests were completed to isolate the difference. Results revealed thatthe largest difference occurred between the PAL group and thecombined pacifier-only and no-contact control groups T = 2.56,p = .01). No otber significant differences were found amongtreatment groups for the SaOy subsample.

Factors potentially affecting pain respon.ses but not analyzedwith demographic variables include medications, multiple heel-sticks during the observed heelstick procedure, and administra-tion of sucrose before or during the heelstick procedure. Withinthe sample of 40 infants for whom SaOg data were available, 18(45 ) were receiving caffeine citrate to decrease incidences ofapnea (Mainous, 1995). These subjects were divided fairly evenlyam ong the three groups, with 7 infants (50 ) of the experimen-

tal, 6 infants (46.15 ) of the pacifier-only, and 5 infants (38.46 )of the no-contact groups. In addition, one female infant in thepacifier-only group was receiving dobutamine and epinephrine,which could affect cardiac functioning, and one male in thepacifier-only group was receiving pentobarbital, a barbituatesedative, which can depress cardiorespiratory func tioning (Main-ous, 1995). No other infants were receiving any medications likelyto affect pain responses. Of the total sample of 60 infants, 3 (2pacifiernanly & 1 no<;ontact) required two needle sticks to satisfy

the necessaiy volume of blood collection. Sucrose was adminis-tered to 16 infants (26.67 ), distributed as 6 (30 ) of the



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This study was performed in a Level III, 110-bed NICU in the

southeastern United States. The researcher identified subjects bydaily reviewing tbe NICU patient summary book, which includedthe specified inclusion and exclusion criteria. The nurse andmedical chart of infants deemed eligible for study inclusion werethen consulted to ensure that exclusion criteria were not omittedfrom the shift report book. Parents were approached regardingtbe study once the researcher identified their infants as havingmet the study inclusion criteria. The procedure and rationale forthe study were explained at that time and parents who agi eed to

enroll their infants in the study signed an Informed Consent. Atthat point, the infant was randomly assigned to one of the threegroups. The researcher reviewed lab orders daily to determinewhen infants whose parents had given study inclusion consentwere scheduled to experience heeisticks. r.

Equipment [

Two identical digital video cameras were used. One camera wasplaced on a tripod beside the infant s bed in ord er to allowvideotaping of tbe entire procedure and the infant s responses atclose range. The other camera, also on an adjustable tripod, wasfocused on the infant s m onitor(s).

The Sondrex® PAL System® is manufactured by HealingHealthcare Systems; the Wee Soothie® and Soothie® pacifiersare distributed by Children s Medical Ventures. The Sondrex®PAL sensor is self-calibrating, adjusting tbe suck pressurethreshold required for music activation based on each infant s

first suck. The default setting for sound duration is 10 seconds,meaning that music will play for 10 seconds following each suckand then cease until the infant sucks again. It is possible forinfants to suck frequently enough to receive continuous music.This lO-second sound duration setting has been used successfullyin previous studies (Standley, 1999, 2000) and was used in thisstudy as well. The level of music was maintained not to exceed65dB, based on American Academy of Pediatrics (1997) recom-mendations and guidelines from previous music therapy studieswith the NICU population (Cassidy Ditty, 1998; Standley, 2003).The Sondrex® speakers default at 65 dB when kept 6 inches from



oumal of f lusic Therapy

traditional lullahies sung by a single female child's voice with

piano accompaniment. This music selection was consistent withresearch regarding optimal auditory stimulation for prematureinfants, as lullabies focus on vowels, which is optimal for languagedevelopment, and have relatively stepwise melodies that are oftensung softly, steadily, and continuously, which reduces risk ofoversti m Illation (Whipple, 2005). Also, m othe r's voice, followedby other female voices, is the auditory stimulus most preferred hyinfants (Standley Madsen, 1990), and simple instrumenta tion,preferably with only one accom panying instrum ent (e.g., piano or

guitar), limits the potential for oversti m ulation (Standley, 2003).The Continuous Response Digital Interface (CRDI) system

incorporates a software program and a box that connects to apersonal com puter via a USB cahle. A maximum of eight dials canbe connected to the CRDI box. Moving from left to right, datapotential ranges from 0 to 255 for each dial (Center for MusicResearch, 2003). The device and software were developed in thelate 1980s at the Center for Music Research at the Florida StateUniversity, with the goal of creating an inexpensive, nonverbalsystem, designed to be multipurpose, easily adapted for varioustypes of measu rem ent (Geringer, Madsen, Gregory, 2004).

For this study, two CRDI dials were used, with one assigned tobehavior state and one assigned to stress level, and two additionalidentical dials connected for reliability observation. For behaviorstate, the following data ranges were determined: deep sleep, 15-54 (35); light sleep, 55-94 (75); drowsy, 95-134 (115); alert 135-174, (155); active, 175-214 (195); and crying, 215-255 (235); and

an additional range of 0-14 to represent any point when view ofthe infant was obstructed. Values in parentheses represent thetarget value for each behavior state, which was marked with a reddot on the dial to increase reliability and consistency of datarecording among subjects. These determinations were hased onthe six standard infant behavior states defined in the Assessmentof Preterm Infan ts' Behavior (Als, Lester, Tronick, Brazelton,1982a). For the stress level dial, a line was drawn at the pointcorresponding to a value of 15, so that all space to the left ofthatline and all values below 15 represented an obstructed view of theinfant and undeterminable stress level. The following correspond-



Vol. XLV . No. 3 Fall 2008 43

purpose of target points, but for guidance to aid in increased

reliability and consistency among subjects: sucking or sleepingwitbout signs of distress, 17; finger splay, leg or foot extension, orgrimace, 35; startle or tremor, 55; whimper, sneeze, yawn, orhiccough, 75; grunting, 95; fussing or halt hand, 120; strugglingmovements, crying, or cry face, 155; intense crying, 195; andintense crying with change of body position in bed, 245. Thesestress behaviors and signs of overstimulation considered duringstress level analysis are samples of those defined by Burns et al.(1994) and Als, Lester, Tronick, and Brazelton (1982b). Engage-ment cues as defined by Burns et al. (1994) were also consideredas reference points when classifying infant behaviors.

Research esign ,

This study employed a multiple sample, posttest only design.Groups included the Sondrex® PAL System®, pacifier-only, andno-contact control. Data collection occurred over a period of 5.5months. A one-trial design was used for each subject.

ependent Measures

Pain and distress are not clearly differentiated in literature , norare effects of noxious versus painful procedures. However,accepted behavioral and physiologic indicators of botb from bothtypes of experiences include changes in HR, RR, SaOg, andbehavior state, and demonstration of specific overt stressbehaviors. Therefore, for this study, the following dependentmeasures were selected for measurement and are considered to

be responses to both painful and otherwise noxious aspects of theheeistick procedure.

Heart and respiratory rates were recorded at 15-second intervalsthrotighout the pre, during, and postprocedure intervals from thevideotape of each infant s monitor. In cases where the monitorwas blocked (e.g., the phlebotomist or nurse stood between thecamera and monitor) or the monitor displayed a noisy signal forHR or RR, the next available data within 5 seconds were recordedfor that particular data po int for both variables. If information wasnot available within 5 seconds for one of the variahtes, the valueavailable for the other variable at the actual 15-second point was



oumal of Music Therapy

were left empty for that 15-second data point. Thirteen data

points for each variable were possible for each baby during the 3-minute pre and postintervals. The du ring-procedure interval was adifferent dura tion for each infant (range; 54 seconds - 13 min-utes, 57 seconds) and therefore, there were 16 to 56 potentialdata poin ts for each variable. For all 60 subjects, at least 50 of alldata points were complete for each variahle for all three intervals.Percentages of collected data ranged from 76.92 to 100 forHR for both pre and postintervals, 84.62 to 100 for RR forboth pre and postintervals, 55.56 to 100 for HR for theduring-p rocedure interval, and 77.78 to 100 for RR for theduring-procedure interval.

Data were also available for SaOg for 40 infants. This variablewas recorded from the monitor videotape at 15-second intervals. IfHR and RR for a particular interval were recorded at a time otherthan the 15-second data point, that same alternate point was alsoused for the SaOg level. However, if SaOg was not available within5 seconds for any data point, the first SaO^ level within the

subsequent 5 seconds was recorded. For the 40 subjects with SaOgdata, 100 of all data points were com plete for the postinterval; atleast 50 of ll data points were complete for the pre and duringintervals, with percentage ranges from 84.62 to 100 and55.56 to 100 for the pre and during intervals, respectively.

A reliability observer recorded the physiologic data of HR, RR,and SaO^ for six of the monitor videotapes (10 of the sample).Interrater reliability was calculated as the percentage of identicalagreement on the sample of data points for each variahle for thesix subjects' videotapes. The combined sample resulted in a totalof 242 data points with interrater agreement of 97.93 (range:91.18 -100 ) for HR, 97.11 (range: 82.35 -100 ) for RR,and 95.04 (range: 83.33 -100 ) for SaO j- The interraterreliability for all physiologic variables for all subjects combinedwas 96.69 .

For infants in hoth control groups and the experimental group,infant hehavior state and stress level were simultaneously and

continuously recorded for the pre, during, and postprocedureintervals using the CRDI system while watching a videotaperecording of the heelstick procedure The CRDI dials were both



Vol. XLV. No. 3 an 2008 5

intervals, and from 54 to 837 data points for the during interval.

Data points below 15 and 17 for behavior state and stress level,respectively, were eliminated, leaving empty cells, as theyindicated an obstructed view of the infant during videotapereview.

A reliability observer watched and recorded data for tbe twobehavior variables for 10 of the sample by watching six infantvideotapes simultaneously with the researcher, recording behaviorstate and stress level using two additional, identical CRDI dials.Interrater reliability was calculated using Pearson product-

moment correlation. Results for individual subject videotapeanalysis ranged from r = 0.88 to r = 0.99 {p < .001 for behaviorstate and r = 0.81 to r = 0.98 {p < .001) for stress level. For thesix subjects com bined, reliability measures were r = 0.95 and r =0.97 for behavior state p < .001) and stress level {p < .001),respectively.

Procedures

The researcher was present in the NICU when infants whoseparents had given consent for study participation were scheduledto have blood collected. The researcher was responsible forproviding all PAL intervention and recording all data for controland experimental infants. A team of phlebolomists and in somecases, the infant's nurse conducted the blood collection heelstickprocedure. A separate spring-loaded heelstick device was used forall infants.

For experimental infants, intervention began approximately

3 minutes prior to the heelstick and continued throughout theduration of and approximately 3 minutes following tlie bloodcollection procedure. Infants were provided the Sondrex® PALSystem®, which played music contingent on infant sucking on aWee Soothie® or Soothie® pacifier. A separate pacifier andtransmitter were used for each infant and the transmitter wasdisposed of following intervention, though the pacifier was left forthe infant's future use. Continuous light, gentle pressure from theresearcher's finger was kept on the pacifier to prevent its slippingor falling otit of the infant's mouth. If necessary to initiate asucking response, the researcher gently stroked the infant's cheek




infant or 30 seconds, whichever came first. If an infant spit ou t or

used his or her tongue to thrust out the pacifier, the researcherwaited 5 seconds, then reinserted the pacifier each time thisoccurred. Additional standard care and pain managementprocedures , such as swaddling, cuddling, and sucrose Als et al.,1986; Als et al., 1996; Bellieni et al., 2001; Gibbins Stevens, 2001 ;VandenBerg, 1995) were not limited for infants in the PALexperimental group.

Infants in the first control group, pacifier-only, were providedeither the Wee Soothie® or Soothie® pacifier, but did not receive

music reinforcement for sucking. Otherwise, procedures were thesame as described for the experimental condition.

For these two conditions, each infant received PAL or pacifier-only intervention on only one occasion. The combined pre,during, and postprocedure inteivals were planned to be limited to15 minutes or less, in ord er to avoid the potentially contaminatingfactor of infant fatigue. While many published pain measurementscales employ a 2-minute observation period prior to andfollowing noxious procedures Lawrence et al., 1993), 8 minuteswas selected as the length of time for pre and postprocedureintervals in this study because infants receiving PAL interventionin previous studies learned to suck with the frequency necessary toelicit con tinuous music in an average of 2.5 minutes Standley,1999, 2000). This 3-minute interval allowed time for infantlearning to occur prior to painful intervention, but in most cases,did not extend the PAL or pacifier-only intervention to a lengththat would increase the likelihood of fatigue, as previous use hasdemonstrated a decrease in sucking near the 14-minute point Standley, 2000). Only 10 infants 5 PAL, 4 pacifier-only, a nd 1no-contact control) had sessions exceeding 15 minutes. Extendedsessions occurred either because the heelstick did not begin asquickly as expected, causing the pre-sucking interval to beextended, or because tbe infant was scheduled to have a largesample of blood collected or was not bleeding well, both factorswhich can cause the actual heelstick procedure to last for anextended period of time.

A final no-contact control group was also included. Infants inthis group were not provided pacifier or music listening



Vol. XLV No. 3. ait 2008 47

other previously de.scribed standard care and pain management

procedures were not limited for infants in this control group.Data Collection

Pre, during, and post intervals were determined duringvideotape review based on the audible click of the heelstickneedle signaling the beg inning of the during-procedure inten al.The pre interval ended 1 second before that and was consideredto have begun 3 minutes and 1 second before the heelstick click.The end of the during-procedure interval was considered to be

the second at which the application of the adhesive bandage wascompleted or the end of the gauze strip bandage was placed,depending which type of bandage was used. The post intervalbegan 1 second later and ended 3 minutes after that. Regardlessof the actual length of pacifier-sucking and videotaping in the preand post intervals, only the 3 minutes immediately prior to theheelstick and the 3 minutes immediately following the conclusionof the blood collection procedure were used for data collection;the entire during-procedure interval was used.

ResultsData were subjected to a variety of statistical computations, with

all /i values acquired via two-tailed tests.

Physiologe Variables

e rt rate Means of HR data were calculated for each infant forpre, during, and post-heelstick intervals, from which group means

were achieved for the same intervals. All group means werecompared for the three treatment groups using MultivariateAnalysis of Variance (MANOVA) with an alpha level of .05. Resultsindicated no significant differences among groups for the threeintervals. To exam ine changes in infant HR from one interval to thenext, differences between the three intervals were calculated foreach infant using the following formulas: during interval minus preinterval, during interval minus post interval, and post intervalminus pre interval. Group mean interval differences were thencalculated (see Tahle 1). Again, no significant differences amonggroups were found for the three mean intervïtl mean differences.



8 oumal of Music Thempy

T LE 1

Heart R ate, Respiratory Rate, and Oxygen Saturation Interval Means and StandardDeviations

. * ; f • • •

1st data pointHR . . .RRSaOa

Pre intervalH RRRSaOa

During intervalH RRRSaOg

Post interval

H RRRSaOs

During - PreH RRRSaOa (Pre - During)

Po.st - PreH RRRSaO-j (Pre - Post)

During PostHRRRSaOg (Post - During)

Post point SaOï > 95%Post point SaOy stays ^% Pre < 86% SaOa During SaOy < 86%% Post SaOa < 86%% Total SaOs < 86%

PAL («

M

158.8562.50*94.36

162.2552.8995.46

179.8748.1495.08

167.8856.1897.81

17.63-4 .75

0,38

5.633.29

- 2 . 3 6

11.998.042.74

1.6495% 3.79

4.948.49

0.554.78

= 141

SD

16.1424.8813.87

8.9317.736.19

13.4116.814.99

12.2117.481.95

10.848.618.06

10.5412.396.46

10.5011.614.27

1.494.51

12.2917.39

2067.39

Pacificr-oniy (n = 13)

M

154.1562.50*95.00

157.3958.0595.45

170.6456.40 *93.44

161.8362.3196.83

13.25-1.65

2.01

4.434.25

-1 .38

8.82-5 .90

3.38

2.154,853.54

15.452.376.85

.SD

19.1319.34

4.53

12,1815.114.25

16.8618.247.52

13.4721,752,57

9.3110.117.57

9.4011.173,31

10,4313.466.34

2.035.557.42

27,644.85

10.79

M

157.4542.4596.54

160.9349.6896.23

178.9445.0694.56

167.3853.3297.43

18.01-4 .63

1.67

6.453.65

-1.19

11.56-8 .27

2.87

1,925.081,184,840.592.66

( = B)

S l

14.0430.17

3.28

11.7910.212.70

15.248.573.a6

•I

15.9515.702.36

15.479.533.44

12.9613,61

1.43

17.7316.213.58

2.475.292.89

11,752.136.04



Vol XLV N o 3 Fall 2008 249

T LE 2

Means and Standard Deviations o f 15 Second Data Po int Heart Rate, Respiratory Rate, an dOxygen Saturation Means

CombinedHRRRS a O .

intervals (n

Pre Interval n = 13)H RRRSaOa

During (nHRRRSaO.¿

Post (n =

HRRRSaOs

= 56)

13)

PA L

M

= 82)181.0646.7795.57

176.6252.8995.46

188.7243.1694.78

167.3856.1897.82

14.6212.092.18

4.155.261,62

11.4012.742.16

4.154.36

.69

PaririiT-only

M

160.6062.0895.76

157.3858.1195.39

161.2163.2495.53

161.8562.3196.83

SI)

7.0610.952.12

3.784.10

.87

8.0313.282.49

5.415.331.27

No-con tiict

M

174.8146.6195.54

161.0049.6896.21

182.2443.1894.54

167.4653.3397.43

Sli

10.6711.60

2.09

2.796.05

.73

5.8913.452.15

6.394.571.09

Note, n refers to the sample of mean data points.

means and standard deviations for the combined and separateintervals were found. Means and standard deviations for HR 15-second interval means are listed in Tahle 2.

To further explain the significant interactions, Pearsonproduct-moment coirelations were completed for all intervalm ean s and interval m ean differences, with the following variables:age in days at tim e of study pa rticipation . Acuity Score , du ratio n ofduring-heelstick interval, duration of sucking prior to heelstick,and behavior state at the first second of the pre-heelstick interval(see Table 3).

Respiratory rate. Respiratory rate means and mean differenceswere calculated for the same intervals as for HR. All means and

mean differences were compared for the three treatment groupsusing a MANOVA (see Table 1). Results indicated a significantdifference among treatment groups for the first data pointF 2



250 Joumal of Music Therapy

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Vol. XLV . No. 3 Fall 2008 25

Statistically significant difference for tbe first data point occurred

between the no-contact group and both the pacifier-only and PALgroups M difference = —20.05, standard error = 7.96, p =.03), with the latter groups displaying a higher initial RR. Theduring-heelstick intei'val difference occurred between the pacifier-only and no-contact control groups (M difference = -1 1 .3 5 ,standard error = 4.64,/* = .04), with pacifier-only group infantsdisplaying a higher mean RR.

Comparisons of RR variability in the forms of means andstandard deviations of each 15-second data point for thecombined and separate intervals are listed in Table 2.

To further explain the significant differences, Pearson product-moment correlations were completed for the interval means andinterval mean differences, with the same variables as for HR (seeTable 3).

Oxy^n saturation. Means and mean differences were calculatedfor SaOa for the same intervals as for HR and RR. However, sinceSaOg would be expected to be higher when HR and RR were

lower, the formulas for determining mean differences werereversed. Interval means and mean differences were comparedfor the three treatment groups using MANOVA. The followingmeasures were also computed and compared: percent of cells forseparate and combined pre-, during-, and post-procedure intervalsin which SaOa was below 86 ; post interval data po int (each da tapoint represented the passing of 5 seconds) at which the infant'sSaO first reached 95 or higher; and the post interval data po intat which the infant's SaO2 remained at 95 or higher. For some

infants, this was the same data point; however, for infants whoseSaOg continued to fiuctuate below 95 thro ughout the postinterval, a value of 4 was used for the second measure, indicatinga point in time beyond the post intei^val, since only IS data pointswere possible for the 3-min post interval. No significantdifferences were revealed among treatment groups (see Table 1).

Comparisons of SaO^ variability in the forms of means andstandard deviations of each 15-s data point for the combined andseparate intervals are listed in Table 2.

Using tbe same variables as for HR and RR, Pearson product-moment correlations were completed and indicated significant




Mean interval d ifference patterns There were some consis tent

patterns in mean interval differences. For the variable of HR,there was an increase for all treatment groups from the pre to theduring-heeistick interval, as was anticipated when designingformulas to determine mean interval differences. However, RRmean interval differences occurred in the opposite direction thanexpected for the pre to during and during to post intervals in allthree groups, indicated by negative values in Tahle 1, which couldindicate apnea, another signal of distress (Burns et al., 1994). Inall three groups, the expected RR increase occurred from the p reto post interval.

For the variable of SaOg for the PAL group, the meandifferences between pre and post intervals occurred in theopposite direction expected, evidenced by negative values inTable 1 as SaOs was higher in the post than pre interval andduring than pre inter\'al. The pacifier-<}nly and no-contact controlgroups displayed mean interval differences as expected in all hutone calculation: an increase from pre to post interval m ean. While

not significant, the PAL group first reached 95 or higher SaOaand remained at or higher than 95 SaO^ at earlier points in thepost interval than the other two groups, and the no-contact grouphad the lowest percentages of intervals in which SaO2 was lessthan 86 for the com bined and separate intervals, except for thepost interval during which the PAL group's percentage of non-optimal SaO2 data points was lowest.

ariability over time Based on standard deviations of the threephysiologic variahles across the entire heelstick procedure and forthe separate pre, during, and postheelstick intervals, SaO2 appearsto be much less variable than HR and RR.

Correlations As shown in Tahle 3, more significant correlationswith physiologic measures occurred for the variahles of AcuityScore and initial behavior state than for other variables, followedby heelstick duration, though heelstick duration correlations wereinconsistent. Few correlations were evident for age and length ofsucking prior to heelstick.

Results of Pearson's product-moment correlations indicatedthat Acuity Score is negatively correlated with HR and positivelycorrelated with RR meaning that as Acuity Score increased (or



Vol. XLV. No. 3 Fall 2008 25 3

within the PAL gioup and mean difference in during and post

interval means for the pacifier-only group. As expected, negativecorrelations of Acuity Score with SaO2 indicate that as AcuityScore increased, SaO-j decreased for the during interval, as well asfor the mean difference hetween during and post interval means.Results also indicated that as Acuity Score increased, percent oftime in which SaOa was less than 86% increased.

Correlations of initial hehavior state with HR and RR measuresindicate that the higher initial behavior state was assessed to be,the higher pre interval no-contact HR and pacifier-only RR meanswere. In addition, as initial behavior state increased, dtiringinterval SaOg means increased and mean differences in pre andpost interval HR means decreased within the no-contact group.Also expected, a higher initial behavior state score was associatedwith an earlier point at which SaO2 reached 95% or greater withinthe post interval for the PAL group, yet was associated with ahigher percentage of time in which SaOa was below 86% withinthe no-contact group.

Consistent with age effects seen in previous studies (Johnston cStevens, 1996; Johnston, Stevens, Yang, et al., 1996), correlationanalysis revealed that as age increased, the mean difference in preand post intei val behavior slate m eans increased for the PALgroup, and the percent of time in which SaO^ was less Lhan 86%during the post interval increased for the no-contact control roup I

Behavioral Variables

Behavior state Means and mean differences were calculated forbehavior state for the same intervals, using the same formulas asfor HR and RR, and again were compared for the three treatmentgroups using MANOVA. Also compared was the percent of datapoints for separate and combined pre-, during-, and post-procedure intervals in which the behavior state CRDI value wasabove 174, which would correspond to the undesirable Active andCrying behavior states. Results indicated significant group

differences for the following measures:• during interval behavior state mean,




• percen t of during interval data points indicating Active and

Crying states, and• percent of com bined interval data poin ts indicating Activeand Crying states.

In all cases Tukey s HSD post hoc analysis indicated that thestatistically significant differences occurred between the pacifier-only and no-contact control groups as well as between the PALand no-contact grotips. In the case of mean difference in pre andduring interval means, the largest difference was between the

pacifier-only and no-contact control groups, but in all other cases,the larger difference was between the PAL and no-contact grotips.Means and standard deviations are listed in Tahle 4, significant F

values in Table 5 and Tukey s HSD post hoc analysis results inTable 6.

In order to evaluate and compare variability of behavior stateover time, the mean of each I-second data point was calculatedand then the mean for the combined and separate intervalsdivided by grotip was found. Means and standard deviations forhehavior state 1 second intei-val means are listed in Table 7 and agraph of behavior state for all groups over time is found inFigure 1

Using the same variahles as for the physiologic data analysis,Pearson product-moment correlations indicated significant cor-relations for all suhjecLs combined as well as within the threetreatment groups. Significant correlations are listed in Tahle 8.

Stress level Stress level means and mean differences were

calculated for the same intervals, using the same formulas as forHR and RR, and again were compared for the three treatmentgroups using MANOVA. Results indicated significant groupdifferences for the following measures:

• pre interval stress level mean,• during interval stress level mean,• post interval stress level mean,• mean difference in pre and during interval means, and

• mean difference in during and post interval means.Post hoc analysis using Tukey s HSD indicated that the statistically



Vol. XLV No. 3 Fall 2008 55

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oumal o Music Therapy

TABLE 5

F Values for Significant Behavior State nd Stress Level Group ifferences

Behavior State

DuringDtiring - PreDuring - Post During > 174 Combined > 174

Stress Level

PreDuringPostDuring - PreDuring - Post

Sum uf Squares

31 023.5551 498.9420.059.6522 700.74

3416.10

1099.9566 938.88

3531.0151 498.9439 905.23

if

22222

2222

Mcaii Square

15.511.7825.749.4710.029.8211.350.37

1708.05

549.833 469.440

1765.5125 749.4719 952.61

12.7511.726.59

11.7911.62

4.1614.089.72

11.728.79

/'

<.OO1<.OO1

.003<.OO1<.OO1

.02<.0Ol<.00I<.OO1<.00I

TABLE 6

Tukey's US for B ehavior State nd Stress Leo el Group ifferences

(GroupsStandard

Fr ro r

Behavior StateDuring

During - Pre

Post - During

During > 174

Total > 174

Stress LevelPreDuring

Post

During - Pre

No-contact

No-contact

No-contact

No-contact

No-contact

No-contactNo-contact

NoK:ontact

No<ontact

PA LPacifiernanlyPA LPacifler-onlyPA L

Pacifier-onlyP L

Pacifier-onlyPALPacifier-only

P.\LPALPacifier-onlyPAL

Pacifier-onlyPAI.Pacifier-only

48.8147.6464.6859.2635.17

41.6042.6439.7316.9314.89

10.3975.0765.7117.95

13.7864.6859.26

11.03

14.82

12.34

9.81

3.83

3.6415.42

4.26

14.82

< .001< .001< 001

.001

.01

.004< .001< 001< .001

.001

.01< .001< .001< .001

.006< .001

.001



I/o/. XLV. No. 3. Fall 2008 7

TABLE 7

Means and Standard eviations of ¡Sertm d Behavior State and Stress Level Means

Co mb ined intervals (n = 1197)

Behavior StaleStress Level

Pre mterval (n = 180

Beh a\ ior State

Stress LevelDuring interval (n = 837)

Behavior StateStress Level

Postinterval (n = 180)

Behavior StateStress Level

I .U.

M

111.2529.16

96.47

21.69

118.6232.45

91.7721.33

Sí)

13.4712.75

3.55

1.34

8.0813.98

6.392.13

P«cini:r-

.M

110.9232.39

103.37

25.68

116.4436.33

99.3725.51

.y t

12.2115.61

5.99

3.29

10.4918.11

10.066.26

146.25 40.5385.17 48.89

100.41 5.36

32.17 5.53

174.79 24.85117.72 35.01

10536 10.9439.29 12.22

Note, n refers to sample of mean data points.

Behavior Stale by Group

M

50

1)

PA L

ci llcr-onlyNo-contact

I K I 541 72 i

Seconds

1081

FIGURE 1.

Behavior state by group.Note. Interval dat a po int ra nge s follow: pre , 1 180; during 181-1017; and post,



258 Joumai of Music Therapy

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Vol. XLV, No. 3, F all 2008 259

Stress Level hy » u p

•PAL

Paciller-oiily

No-con lac

1081

F I G U R E 2 .

Sirt'ss level by grou p.Note Interval data point ranges follow: pre. 1—18 ; durin[r lHl-1017; and post,

1018-1197. Sample .size decreased following d a u point 234 and resumed to full sizeal data point 1018. Lint- breaks indicate that data were not recorded for any

subjects in thai treaiinent group for those data points.

the significant differences occurred both between the pacifier-only and no-contact control grotips and between the PAL and no-contact groups, though the differences were greatest between thePAL and no-contact groups. Means and standard deviations arelisted in Table 4, significant F values in Table 5, and post hocanalysis results in Tahle 6.

Comparisons of stress level variahilit)' in the forms of means andstandard deviations of each l-second data point for the combinedand separate intervals are listed in Table 7 and a graph of stresslevel for all grotips over time is found in Figure 2.

LIsing the same \^driahles as for the physiologic data andbehavior state analysis, Pearson product-moment correlationsindicated significant correlations for all subjects combined andwithin the three treatment groups (see Table S).

Mean interval difference patterns There are some consis tentpatterns in mean inlenal difierences. For the variables ofbehavior state and stress level there were increases as anticipated




mean was less than pre interval mean for stress level for PAL and

pacifier-only groups, indicating that decreases throughout thepost interval led to behavior state and stress level means less thanbaseline measures.

For the measure of behavior state, the percent of time spent inActive and Crying behavior states for combined and separateintervals was lowest for PAL group infants, followed by pacifier-only group infants. These différences were significant for the PALand pacifier-oniy groups compared to the no-contact group.

ri bility over time Based on standard deviations of the twobehavioral variables across the entire heelstick procedure and forthe separate pre, during, and postheelstick intervals, behavior stateand especially stress level appear to be more stable for the PALgroup than for the other two groups. For behavior .state, standarddeviations were smallest for the PAL group for the pre-, during-,and post-heelstick means, though the pacifier-only group displayedthe smallest standard deviation for all intervals combined. Thelargest standard deviations in the combined, during, and postintervals occurred for the no-contact gronp. For stress level,standard deviations were smallest for the PAL group and largestfor the no-contact group for all separate and combined intervals.

Graphic analysis of the beha\'iora variables supports thestandard deviation comparisons for the three treatment groups.There was an observable initial increase in behavior state andstress level at the beginning of the dtiring interval for all threetreatment groups. This initial increase was greater for the no-contact group than for the PAL and pacifier-only groups and

remained at the higher level, while stress level for the PAL andpacifier-only grotips began to decrease slightly. The PAL andpacifier-only groups showed some variability during the remain-der of the during interval, more for stress level than behaviorstate, while the no-tontact group displayed several observablespikes in stress level and behavior state. Toward the end of theduring interval, however, no-contact group behavior state andstress level dropped to levels close to those of the PAL andpacifier-only groups. At the beginning of the post interval, therewas a drop in behavior state and stress level for all three groupsthat continued to decrease then stabilize.



o XLV No. 3 Fail 2008 261

behavior state than other variables, followed by Acuity Score, then

age and heelstick diuation. No correlations were evident forlength of sucking prior to heelstick. It should be noted that theinitial behavior state measure is included iiï the pre interval, asfour of the nine .significant correlations for initial behavior statewere within the pre interval and two were for a comparison of thepre and post intervals. Results of Pearson product-momentcorrelations indicated that as initial behavior state increased,during and pre interval behavior state means increased, postinterval stress level means decreased, and mean differencesIjetween pre and post interval stress level means were reduced,dem onstrating potential influence of this variable beyond the preinterval.

Acuity Score was negatively correlated with during intervalbehavior state means and mean differences between pre andduring interval behavior state and stress level means, and duringand post interval stress level means within the pacifier-only group,meaning that as Acuity Score increased, those values for pacifier-

only infants decreased. Other negative correlations indicated thatas age increased, post behavior state means within the pacifier-only group decreased, as did the difference between during andpost interval stress level means for the PAL group, hoth consistentwith age efTects found in previous studies (Johnston ; Stevens.1996; Johnston, Stevens, Yang, et al., 1996). In add ition, asheelstick duration increased, mean differences between duringand post interval stress level means decreased within the pacifier-only group. Finally, longer heelstick durations were associated

with higher percentages of time spent in Active and C^ryingbehavior states witiiin the no-contact group only.

DiscussionGreater treatment group differences were evident for behavior-

al than physiologic measures. Examination of means and standarddeviations revealed that much more variability existed across timewithin all groupings for the HR and RR measures than for SaOa,

behavior state, and stress level. Potential causes for the lack ofsignificance within physiologic results are numerous.Fi t th i bl f RR i h tl fl d b th




specifically. Still, the measure of RR was included in this .study

since changes in movemeni could indicate distress. Furtlier, themean first RR data point was significantly higher for the PAL andpacifier-only groups than for the no-contact group. This couldhave been relatt^d to initial pacifier placement that, in many cases,had just occurred. On the other h and , this difference could havebeen a baseline difference caused by unknown factors. Alsosupporting inconsistencies within the RR measure is the fact thatfewer significant correlations were found for demographicvariables with RR than with any other physiologic or behavioralmeasure. The relatively inconsistent pattern of RR may indicatethat it is not a reliable measure. Smaller standard deviations maysignal SaO^ as a more reliable indicator of pain and distress thanHR and RR for the population this study.

Also, while much research regarding NNS and HR has indicateda calming effect of NNS manifested in lower HR, the fact that bothof the groups with larger HR increases were provided withopportunities for NNS may also indicate that their increase in HR

between the pre and during intei-vals was due to self-regulatorysucking on the pacifier, as Woodson and Hamilton (1986) founda significant positive correlation for HR with motor activity inpreterm infants due t(ï their common association with energyexpenditure. Further, since the PAL is designed and has beenshown to increase pacifier sucking (Standley, 2000), this effectcould explain why the PAL group had the highest during intervalHR mean.

Further, while changes in HR, RR, and SaOa coincided with theintroduction and withdrawal of noxious stimiili, group intervalmeans remained within normal limits (Burns et al., 1994),possibly reducing the chance for significant physiologic differ-ences among grotips.

Still, there seems to be some physiologic evidence that the PALis beneficial for facilitating return to homeostasis wilhin thepostheelstick period. Th e standard deviations for HR and RR overtime were smallest for the PAL group for the post interval, thoughthey had been larger than the other two groups for the combinedand pre intei-vals for HR and RR and liad been the largest for theduring intewal for HR In addition the PAL group first reached



Vol. XLV No. 3 Fall 2008 2 6 3

for the PAL group, there were mean increases in SaOa and frompre to post intei vals, larger than the other group increases. Thispattern is important because it is opposite expected outcomes,with SaO-2 higher in the post-procedure interval than in the pre-procedure interval, which functioned as the ha.seline perio d. Still,this should be considered cautiously since Acuity Score was foundto be .significantly higher for PAL SaO^ subjects than for the othertwo gioups combined, and some negative correlations for Acuity-Score with SaOa for during and mean interval differences werefound, though not for the specific measxues discussed.

Unlike the physiologic measures, behavioral measures in thisstudy revealed many significant group differences. Behavioralobservation is important within this study. First, interraterreliability was high for behavior state and stress level assessment.In addition, a meta-analysis completed by Standley and Whipple(2003) regarding music tberapy treatment with pédiatrie patients,though not including the NICU population, indicated thatbehavioral observations tend to be more conservative than

physiologic measures. Further, in the current study, the initialassessment measure of behavior state was significantly correlatedwith multiple physiologic as well as behavioral measures. Finally,DiPietro, Cusson, Caughy, and Fox (1994) found tbat NNS maylessen behavioral distress for preterm infants without alteringphysiologic responsiveness.

Supporting the use of music-reinforced NNS for preterm, LBWinfants experiencing heelstick, results of this study indicate thatthe PAL group had significantly lower during interval behaviorstate means, smaller mean differences in pre and dining intei-\aland during and post inter\'al behavior state means, and spent lesstime in Active and Crying states for the combined and duringintervals than the no-contact group. Competent development isrepresented by smoothness in modulation, regulation, anddifferentiation of five observable behavioral subsystems offunctioning: autonomie, motor, state regulatory, attention/interactive, and self-regulatory. Aroused states are characterizedby high levels of motor activity and disorganized behaviorpatterns, and may be counterproductive to energy conservation(Als k. Duffy, 1989). In addition , the PAL group had significantly



6 ournal of Music Therapy

I

interval stress level means. Except for the pre interval mean

difference which was significant only between the PAL and no-contact groups, these differences also occurred for the pacifier-only control group compared to the no-coutact control group,though the differences were greatest hetween the PAL and no-contact groups. Also, as with changes in SaO2 that signaled retu rnto homeostasis, the post interval stress level mean was less than thepre inteiTal mean for the PAL and pacifier-only groups, asdecreases throughout the post interval led to behavior state andstress level means less than baseline measures, though groupdifferences were not significant.

Behavior state and stress level also appear to be more stable forPAI, than for the o ther two treatm ent groups. Standard deviationsfor behavior state were smallest for the PAL group for the threeseparate intervals, and for stress level, PAL group standarddeviations were smallest for the combined and separate intervals.The largest standard deviations, and therefore most variation,were found in the no-<:ontact group for combined, during, and

post intervals for behavior state and for all combined and separateintervals for stress level.Interestingly, a higher initial behavior state score was associated

with an earlier point at which SaO^ reached 95 or greater withinthe post interval for the PAI., grovip only, yet was also associatedwith a higher percentage of time in which SaOs was below 86within the no-contact group, These seemingly opposite significantcorrelations seem to further support the use of music-reinforcedNNS in pain management.

This study has some limitations, as many variables of theheelstick procedure itself were beyond the control of theresearcher. Procedural changes could include the addition of aseparate baseline measurement prior to the period of time whenpreparation for the heelstick procedure occurs. In this study,preparation for the heelstick occurred at any point in time duringthe pre interval. For all infants, heelstick preparation progressedas follows: removal of hiankets and clothing from the infant's foot,placement of heel-warmer on the infant's foot, and cleansing ofthe heelstick site, followed by the actual heelstick using a spring-loaded heelstick device However for some infants these steps



Vol XLV No 3 all 2008 265

the official pre interval period. This variability meant that .some

infants were handled more frequently than others and eliminatedthe possibility for an actual baseline mea.surement. Mvich variationalso existed within the method used for blood collection, asphlebotomists and nurses used different techniques for encour-aging blood flow. Some squeezed, while other f iexed the infant sfoot; some scraped the vial along the infant s hee l, while othersallowed the blood to drop into the vial. Reduction in this processvariation could be achieved by enlisting only one phlebotomist ornurse to collect blood for the heelstick procedures used for data

collection, or by enlisting cooperation from the team ofphlebotomists and nurses in use of a specific, consistenttechnique. In addition, separate intervals for bandaging theheelstick site following blood collection and for post procedtirerecovery could also be beneficial and could help in future analysisto determine if decrease in physiologic and behavioral indicatorsof distress observed in graphic analysis occurred during thebandaging period, were due to a shut-down effect caused byoverstimulation or pain saturation with longer periods of painfulstimulation, or were caused by outliers since the sample becamesmaller as time passed within the during interval.

Duration of sucking prior to the heelstick was also affected bylack of control over the heelstick procedure itself Fatigue is apotential concern of extended length of NNS. Therefore , theprocedure was designed to incltide 3 minutes of S for PAL andpacifier-only infants prior to the heelstick. However, this timeperiod actually ranged from 3 min, 15 s to 10 min, 40 s, as it was

not possible for the researcher to know exactly when thephlebotomist wotild begin the heelstick for each infant. Eachphlebotomist had multiple infants from which to collect bloodeach day, all with varying heelstick procedure time requirements,and could not always accurately anticipate the amount of timeuntil he or she would arrive at an infant s bedside. Fewcorrelations were found for sucking duration prior to heelstick,which can be interpreted to mean that longer NNS periods didnot seem to limit effectiveness of the PAL or pacifier-oniyinterventions. In a meta-analysis of studies involving NNS forneonates, Shiao et ai. {1997) found larger effects on reducing HR




studies reviewed ranged from 2 to 5 min , com pared to 6 min, 18 s

to 27 min, 33 s of total NNS in this study. Therefore , it may be sdlladvisable to attempt greater control of this variable in futureresearch.

Since so many significant correlations were revealed for initialbehavior state, age. Acuity Score, sucking duration prior toheelsiick, and heelstick duration variables with physiologic andbehavior measures, greater control over these factors may need tobe established. To reduce variability in heelstick duration, datacollection could be limited to heelstick procedures in which a set

am ount of blood (e.g., one vial) is to he collected. This would alsolikely reduce incidences of multiple heeisticks heing necessaryduring a single heelstick procedure. Criteria could also be set forinfant age and Acuity Score. However, excluding infants based onthese factors could limit the opportunity to document painmanagement benefits for younger, less stable infants who arelikely to experience more heeisticks (Barker & Rutter, 1995). Inlight of evidence of long-term detrim ental effects of neonatal pain(Anand, 1998, 2000; Oberlander et al., 2000), it may instead bebeneficial to employ Analysis of Covariance (ANCOVA) proce-dures including these variables in future study. Of course, all ofthe suggested procedure adaptations require greater control overthe heelsdck procedure and are only possible with facilitycooperation. Further, highly controlled studies may yield less real results, as clinical application of these procedures willnecessarily bave the variability that was evident in this study.

Initially, physiologic data was to be downloaded from cardio-

respiratory and SaOs monitors, providing continuous data thatcould be correlated with continuous behavior state and stress leveldata obtained using the CRDI .system. Since this option was notavailable within the Sondrex® PAL System® at tbe time of studyimplementation, the format of tables and graphs allowed forcomparison of those variables. The data point at which the actualheelstick occurred was not included in analysis due to the delayeddisplay of its effect on the monitor, which caused this point to bedifficult to determine. In future study, especially with continuousdata, it might be possible to capture that information. Tbe abilityto download frequency and strength of infant sucking for the PAL



Voi. XLV No. 3 Fail 2008 67

during the pre interval, as those variables could be affected by

NNS as well as heelstick preparation procedtires. In addition,sucking data could be compared to peaks and valleys inphysiologic and behavioral changes. Future research shouldinclude this option once it is made available by the manufacturer.

Additional study may also support use of music-reinforced NNSduring other painful and stressful procedures frequently experi-enced by premature infants, to include intubation, endotrachealsuctioning, peripheral venous cannula and line insertion,umbilical catheter placement, intramuscular injection, lumbarpuncture, and chest drainage (Barker c Rutter, 1995), as well asduring dressing changes and eye exams. During suctioning forventilator-dependent infants, the continuous music function ofthe Sondrex® PAL System® could be used for infants unable toconsistently produce adequate sucking strength and frequency toactivate the contingent music function. In addition, music-reinforced NNS might be beneficial for term or older preterminfants during circumcision. Some insight could also be gained byobserving PAL effects on ilR. RR, SaO2, behavior state, and stresslevel imder non-painful conditions. Since NKÛ infants freqtientlyexperience distress, regardless of the presence of an actual painfulevent, such investigation could potentially provide support for useof the Sondrex® PAL System® for modtilating preterm, LBWinfant behavior in non-painful situations. One such use could befacilitation of Alert states optimal for feeding, as preterm neonateshave limited periods of alertness and those periods are ideal forinteractions that may tax their limited ability to maintain

beba\aoral organization (Pickler, Frankel, Walsh, c

Thompson,1996). Finally, it is possible that the combination of music andNNS in this study became oversti m ulating once the painfulstimulus of the heelstick was introduced. Beaver (1987) foundthat stroking the infant s leg during a heelstick procedureappeared to be more aversive to preterm infants than theheelstick alone, based on changes in physiologic measures fromthe baseline period. That same effect may have occurred in thisstudy for the PAL group within the during-heeistick interval. If

that is the case and this population of infants would be betterserved with only one additional input dtning noxious or painful



8 oumal of Music Thempy

postprocedure intervals, with use of the pacifier alone once

painful or noxious procedure begins.This study provides much evidence to support benefits of mureinforced NNS for attenuating behavior stale and stress leincreases for preterm, LBW infants experiencing heelstick. Sinformation documents another method of nonpharmacolopain management for the population of premature infants, aidentifies an additional benefit of the Sondrex® PAL System ^

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The Effect of Music-Reinforced Nonnutritive Sucking on State of Preterm, Low Birthweight Infants Experiencing Heelstick