16

CHAPTER II

REVIEW OF LITERATURE

2.1 REVIEW OF LITERATURE

Review of literature refers to the activities involved in searching for information

on a topic and developing a comprehensive picture of the state as knowledge on that

topic ( Polit & Hungler, 1993).

Therefore the researcher studied and reviewed the related literature to broaden

the understanding about the topic to gain insight in to the selected problem

Section A: Literature regarding complementary therapies for hypertension

Section B: Literature regarding biofeedback on hypertension

Section C: Literature regarding anxiety among hypertensive patients

Section D: Literature regarding biofeedback on anxiety

Section A: Literature regarding complementary and alternative therapies for

hypertension

Hänsel & Känel (2012) presented a narrative review focusing on the current

stress concept and factors that influence the degree of blood pressure change following

a psychosocial stressor. Relevant psychosocial factors such as marital status, social

support, socioeconomic status, work conditions, personality and cognition on blood

pressure were discussed. It also focused on the outcome of cognitive-behavioural

therapies and relaxation techniques as a means to effectively control blood pressure.

They concluded that psychosocial factors and stressors may increase blood pressure

and agreed that with respect to therapeutic options, cognitive-behavioural interventions,

17

combined with relaxation techniques all fitting the needs of the individual patient best

can offer a clinically meaningful contribution of an effective blood pressure control.

Anderson and Taylor (2012) compared complementary and alternative

medicine (CAM) use among those individuals in the United States who have known

coronary heart disease; n = 1055, general population among individuals who are not

having CVD or CVD risk factors, n = 22 290, as well as individuals with CVD risk

factors (hypertension, n = 6849 or high cholesterol, n = 5808) through secondary

analyses of the 2007 National Health Interview Survey data. Use of complementary

practices and products by patients with CVD and CVD risk factors was common and

significantly greater than individuals without CVD in the general population. The most

common categories of complementary modalities used by individuals with a self-

reported diagnosis of CVD or CVD risk factors were natural products and mind-body

practices.

Agte , Jahagirdar and Tarwadi (2011) undertook an open label intervention

study on 26 mild hypertensives and 26 apparently healthy adults of age group 30-60

yrs, for the effect of Sudarshan Kriya Yoga practice for two months as complementary

therapy. In the hypertensives, there was a significant decrease in diastolic blood

pressure (P < 0.01), serum urea (P < 0.01) and plasma MDA (malondialdehyde

adducts) as oxidative stress marker (P < 0.05). The pattern of change in most of the

study parameters was such that values above normal range were lowered but values

within normal range were unaltered.

Edwards , Wilson , SadjaJ, Ziegler and Mills (2011) investigated the effects

of lifestyle interventions on autonomic nervous system function in patients with

elevated BP. Sedentary participants with elevated BP were randomly assigned to either

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an exercise only (N = 25), exercise plus dietary approaches to stop hypertension

(DASH) diet (N = 12), or waitlist control (N = 15) 12-week intervention. Plasma nor

adrenaline was measured at rest and participants performed a peak exercise test before

and after the intervention. Heart rate recovery (HRR) was calculated as peak heart rate

(HR) minus HR at 1 min post-exercise. Similarly, exercise plus diet and exercise

groups, but not waitlist, showed significant increase in HRR, significant reductions in

BP from pre- to post-intervention. Linear regression revealed that BP post-intervention

was significantly predicted by change in HRR when controlling for pre-BP, age, gender

and BMI. Lifestyle interventions induced BP reduction and altered autonomic tone,

indexed by HRR. This study indicates the importance of behavioural modification in

hypertension and that increased parasympathetic function is associated with success in

reduction of BP.

Ireland, MacKenzie, Gould, Dassinger, Koper and LeBlanc (2010)

addressed the need to improve risk factor outcomes through identifying clients with

uncontrolled hypertension. Cognitive, self-efficacy and/or adherence characteristics

predictive of non-achievement of blood pressure targets and an expanded nurse case

management care delivery model was pilot tested for feasibility in a participant sample

of 20 clients. Motivational interviewing and self-management approaches were

combined with interventions designed to improve adherence: facilitation of the

simplification of medication routines, providing memory cues, home self-monitoring

equipment, counselling, and six-month nursing follow-up. At six months, there were

significant reductions in blood pressure and increases in medication self-efficacy and

adherence for selected clients identified with high risk for stroke and non-achievement

of treatment outcomes.

19

Tang, Harms and Vezeau ( 2008) conducted a pilot study with purpose to

evaluate the effectiveness of an audio relaxation tool for lowering blood pressure and

augmenting heart rate variability (HRV) in older adults. Fourteen older adults (83 +/- 8

years) participated in the study. The intervention consisted of 12 sessions of a guided

relaxation program. Blood pressure was taken before and after each intervention. HRV

was assessed once before training and at the conclusion of the final session. Paired

sample t tests were used for data analysis. Comparing pre and post parameters for all

sessions, the intervention resulted in a statistically significant reduction in systolic

blood pressure (P < .001), diastolic blood pressure (P < .001), and heart rate (P < .005).

HRV was unaffected. This study provides support for the use of guided relaxation to

reduce high blood pressure in older adults.

Nahas (2008) reviewed the evidence supporting complementary and alternative

medicine approaches used in the treatment of hypertension. MEDLINE and EMBASE

were searched from January 1966 to May 2008 combining the key words hypertension

or blood pressure with acupuncture, chocolate, cocoa, coenzyme Q10, ubiquinone,

melatonin, vitamin D, meditation, and stress reduction. Clinical trials, prospective

studies, and relevant references were included. Evidence from systematic reviews

supports the blood pressure-lowering effects of coenzyme Q10, polyphenol-rich dark

chocolate, Qigong, slow breathing, and transcendental meditation. Vitamin D

deficiency is associated with hypertension and cardiovascular risk; supplementation

lowered blood pressure in 2 trials. Acupuncture reduced blood pressure in 3 trials;

melatonin was effective in 2 small trials. Investigators suggested that several

complementary and alternative medicine therapies can be considered as part of an

evidence-based approach to the treatment of hypertension.

20

Dickinson et al. (2008) evaluated the effects of relaxation therapies on

cardiovascular outcomes and blood pressure in people with elevated blood pressure.

Meta-analysis of 25 RCTs, with eight weeks to five years follow-up, indicated that

relaxation resulted in small, statistically significant reductions in SBP (mean difference:

-5.5 mmHg, 95% CI: -8.2 to -2.8, I2 =72%) and DBP (mean difference: -3.5 mmHg,

95% CI: -5.3 to -1.6, I2 =75%) compared to control. The nine trials that reported

blinding of outcome assessors found a non-significant net reduction in blood pressure

(SBP mean difference: -3.2 mmHg, 95% CI: -7.7 to 1.4, I(2) =69%) associated with

relaxation. The 15 trials comparing relaxation with sham therapy likewise found a non-

significant reduction in blood pressure (SBP mean difference: -3.5 mmHg, 95% CI: -

7.1 to 0.2, I(2) =63%).

Linden and Moseley (2006) reviewed evidence for the efficacy of behavioral

treatments for hypertension. Extensive evidence from over 100 randomized controlled

trials indicated that behavioural treatments reduced blood pressure (BP) to a modest

degree, and this change was greater than what is seen in wait-list or other inactive

controls. Effect sizes were quite variable. The observed BP reductions were much

greater when BP levels were high at pre-test, and behavioural studies tend to

underestimate possible benefits because of floor effects in their protocols. Multi-

component, individualized psychological treatments lead to greater BP changes than do

single-component treatments. Among biofeedback treatments, thermal feedback and

electrodermal activity feedback fared better than EMG or direct BP feedback, which

tended to produce null effects.

Yeh, Davis and Phillips (2006) conducted a study using the 2002 National

Health Interview Survey and analyzed data on CAM use in 10,572 respondents with

21

cardiovascular disease. Among those with CVD, 36% had used CAM in the previous

12 months. The most commonly used therapies were herbal products (18%) and mind-

body therapies (17%). Among mind-body therapies, deep-breathing exercises and

meditation were most commonly used. Overall, CAM was used most frequently for

musculoskeletal complaints. Mind-body therapies were also used for anxiety or

depression (23%) and stress or emotional health and wellness (16%). Fewer

respondents (10%) used CAM specifically for their cardiovascular conditions (5% for

hypertension, 2% for coronary disease, 3% for vascular insufficiency, < 1% for heart

failure or stroke) however most of them perceived the therapies to be helpful (80% for

herbs, 94% for mind-body therapies). CAM use was more common in younger

respondents, women, Asians, and those with more education and greater incomes. In

was concluded that, CAM use, particularly herbs and mind-body therapies, is common

in the United States in patients with cardiovascular disease and mirrors use in the

general population.

Tibbits, Ellis, Piramelli, Luskin and Lukman (2006) conducted a study with

objective to determine if patients with diagnosed stage-1 hypertension could benefit by

a forgiveness training program to achieve measurable reductions in anger expression

and blood pressure. Twenty-five participants were randomly divided into wait-listed

control and intervention groups. The control group monitored blood pressure while the

intervention group participated in an 8-week forgiveness training program. At the end

of eight weeks, the wait listed group became an intervention group. Those who

received forgiveness training achieved significant reductions in anger expression when

compared to the control group. While reductions in blood pressure were not achieved

by all the participants, those participants who entered the program with elevated anger

expression scores did achieve significant reductions in blood pressure.

22

Ernst (2005) summarised the evidence from clinical trials of numerous herbal

remedies in which non-herbal remedies and other approaches have been tested and

some seemed to have antihypertensive effects. They felt that the effect size was usually

modest, and independent replications were frequently missing. According to them, the

most encouraging data pertain to garlic, autogenic training, biofeedback and yoga.

Section B: Literature regarding biofeedback on hypertension

McGrady (2010) described that the metabolic syndrome was likely to develop

in patients in whom genetic predisposition, chronic stress, negative emotion, and

unhealthy lifestyle habits converge. In light of the psycho-physiologic aspect of most of

these factors, biofeedback, relaxation, and other psycho-physiologic interventions have

been studied and used in patients with elements of the metabolic syndrome, particularly

diabetes and hypertension. The article reviewed the rationale and evidence for

biofeedback for the treatment of diabetes and hypertension, which has been shown to

effectively lower blood glucose and blood pressure in numerous studies. Investigator

felt that patients with pre-hypertension are particularly appropriate target population

for biofeedback for blood pressure reduction.

Tsai, Chang, Chang, Lee and Wang (2007) examined whether a 4-week

blood pressure (BP) biofeedback program can reduce BP and BP reactivity to stress in

participants with mild hypertension in a randomized controlled study. Participants in

the active biofeedback group (n=20) were trained in 4 weekly laboratory sessions to

self-regulate their BP with continuous BP feedback signals, whereas participants in the

sham biofeedback group (n=18) were told to manipulate their BP without feedback

signals. BP, skin temperature, skin conductance, BP reactivity to stress, body weight,

23

and state anxiety were assessed before training and repeated at the eighth week after the

training. The decreases in systolic (12.6 +/- 8.8 versus 4.1 +/- 5.7) and mean BP (8.2

+/- 6.9 versus 3.3 +/- 4.9) from baseline at week 12 follow-up were significantly greater

in the active biofeedback group compared with the sham biofeedback group (p=0.001

and 0.017, respectively). The pre-to-post differences in skin conductance and SBP

reactivity were statistically significant for the biofeedback group (p=0.005 and 0.01,

respectively), but not for the control group. They concluded that BP biofeedback

exerted a specific treatment effect in reducing BP in individuals with mild

hypertension, possibly through reducing pressor reactivity to stress.

Khanna, Paul and Sandhu (2007) evaluated the effect of progressive muscle

relaxation training and galvanic skin response biofeedback training in reducing the

blood pressure and respiratory rate of stressed female students of age group 18–27 yrs.

Their stress level was assessed using Comprehensive Anxiety Test questionnaire. It

was administered to about 120 females undergraduate, post graduate, graduate and

research scholars from Guru Nanak Dev University, Amritsar, India. 30 highly stressed

females with high anxiety scores, who were free from any ailments and not undergoing

any kind of medication treatment were chosen for the study. Of these subjects, 20 were

randomly fedback from the machine. Blood pressure was measured using

sphygmomanometer with conventional method and respiratory rate was recorded by

observing the movement of chest wall for one minute. There were two training groups:

GSR biofeedback training (n = 10) and PMR training (n = 10). The remaining 10

subjects were taken as control. The training was provided for 20 min daily for 10

consecutive days. Results indicated that PMR group showed significant differences for

SBP (P<0.05) and DBP (P<0.001). Pre and post session comparison of blood pressure

values of GSR biofeedback group on day 1 revealed significant reduction in SBP

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values (P<0.05) while no effect was observed for DBP while on day 10, both SBP and

DBP values showed significant differences in pre and post session values. Results

indicated the effectiveness of GSR biofeedback training in reducing blood pressure

after training session. PMR group showed significant reduction in pre-post session

values of SBP and DBP on day 10 only. Control group (group 3) did not show

significant results on both day 1 and day 10 .

Toshiho, Kazuhiro, Fusae and Haruna (2006) demonstrated the efficacy of

biofeedback (BF) therapy using electroencephalograms (indirect method) and BF

therapy using a monitoring system in the treatment of hypertension and white-coat

hypertension, and reported that a combination of BF therapy (indirect method) and

relaxation therapy was also effective. In the present study, they compared the effects

of a combination of the direct method and relaxation therapy (11 cases) for essential

hypertension with those of the direct method alone (20 cases). After BF therapy,

systolic blood pressure, diastolic blood pressure, anxiety score, and depression score

decreased significantly in both groups. Comparing the two groups, significantly higher

effects on systolic blood pressure, diastolic blood pressure, anxiety score, and

depression score were obtained in the combination therapy group than in the mono-

therapy group.

McGrady, Nadsady and Schumann-Brzezinski (2005) assessed the usefulness

of biofeedback-assisted relaxation as an adjunct or substitute for pharmacotherapy in

essential hypertension and whether can be enhanced if the effects are shown to persist

after formal treatment has ended. Patients with essential hypertension successfully

treated with biofeedback-assisted relaxation were recalled for follow-up yearly after the

termination of treatment. Twenty-six of 40 patients met the BP criterion for success. At

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one-, two-, and three-year follow-up, 31%, 38%, and 27% of the successful completers

continued to meet the criterion for success. The pretreatment-posttreatment decreases in

BP were accompanied by decreases in forehead muscle tension and urinary cortisol.

Forehead muscle tension, urinary cortisol, and anxiety levels were significantly lower

than pretreatment one year after the end of treatment. Self-report data were used to

assess continued relaxation practice. It was concluded that some patients trained in

biofeedback-assisted relaxation can maintain lowered blood pressure, muscle tension,

anxiety, and cortisol levels over the long term.

Carolyn et al. (2005) conducted a study was to determine the effectiveness of

biofeedback in the treatment of stages 1 and 2 essential hypertension via meta-

analytical methods. A utilization-focused integrative review was limited to adult

randomized clinical trials, and study groups were categorized into biofeedback, active

control, and inactive control. Both biofeedback and active control treatments resulted in

a reduction in systolic blood pressure (SBP) and diastolic blood pressure (DBP). Only

biofeedback (with related cognitive therapy and relaxation training) showed a

significantly greater reduction in both SBP (6.7 mm Hg) and DBP (4.8 mm Hg) when

compared with inactive control treatments. The investigator also suggested that nurses

in practice settings should consider biofeedback therapy for their hypertensive clients.

Yucha et al. (2005) conducted a study to develop a way to predict which

persons with essential hypertension would benefit most from biofeedback-assisted

relaxation (BFAR) training. The authors evaluated the effect of BFAR on blood

pressure (BP) reduction, which was measured in the clinic and outside the clinic using

an ambulatory BP monitor. Fifty-four adults with stage 1 or 2 hypertension (78%

taking BP medications) received 8 weeks of relaxation training coupled with thermal,

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electromyographic, and respiratory sinus arrhythmia biofeedback. Blood pressure was

measured in the clinic and over 24 hours using an ambulatory BP monitor pretraining

and posttraining. Systolic BP dropped from 135.0 ± 9.8 mm Hg pretraining to 132.2 ±

10.5 mm Hg posttraining (F = 6.139, P = .017). Diastolic BP dropped from 80.4 ± 8.1

mm Hg pretraining to 78.5 ± 10.0 mm Hg posttraining (F = 4.441, P = .041). Data from

37 participants with baseline BP of 130/85 mm Hg or greater were used to develop a

prediction model. Regression showed that those who were able to lower their SBP 5

mm Hg or more were (1) not taking antihypertensive medication, (2) had lowest

starting finger temperature, (3) had the smallest standard deviation in daytime mean

arterial pressure, and (4) the lowest score on the Multidimensional Health Locus of

Control-internal scale. Author suggested that since these types of persons are most

likely to benefit from BFAR, they should be offered BFAR prior to starting

hypertensive medications

Del Pozo et al. (2004) tried to determine if cardio respiratory biofeedback

increases heart rate variability (HRV) in patients with documented coronary artery

disease (CAD). Patients with established CAD (n = 63; mean age, 67 years) were

randomly assigned to conventional therapy or to 6 biofeedback sessions consisting of

abdominal breath training, heart and respiratory physiologic feedback, and daily

breathing practice. HRV was measured by the standard deviation of normal-to-normal

QRS complexes (SDNN) at week 1 (pretreatment), week 6 (after treatment), and week

18 (follow-up). The SDNN for the biofeedback and control groups did not differ at

baseline or at week 6 but were significantly different at week 18. The biofeedback

group showed a significant increase in SDNN from baseline to week 6 (P < .001) and to

week 18 (P = .003). The control subjects had no change from baseline to week 6 (P =

.214) and week 18 (P = .27).

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Nakao, Yano, Nomura and Kuboki (2003) tried to examine the blood

pressure-lowering effects of biofeedback treatment in patients with essential

hypertension, a meta-analysis was conducted on studies published between 1966 and

2001. A total of 22 randomized controlled studies with 905 essential hypertensive

patients were selected for review. Compared with clinical visits or self-monitoring of

blood pressure (non-intervention controls), biofeedback intervention resulted in systolic

and diastolic blood pressure reductions that were greater by 7.3 mmHg (for systole;

95% confidence interval: 2.6 to 12.0) and 5.8 mmHg (for diastole; 95% confidence

interval: 2.9 to 8.6). Compared with sham or non-specific behavioural intervention

controls, the net reductions in systolic and diastolic blood pressures by biofeedback

intervention were 3.9 (95% confidence interval: -0.3 to 8.2) and 3.5 (-0.1 to 7.0)

mmHg, respectively. The results of multiple regression analysis also indicated that

biofeedback intervention decreased systolic and diastolic blood pressures more than

non-intervention controls (p < 0.001), but not more than sham or non-specific

behavioural intervention controls (p > 0.05), when controlling for the effects of initial

blood pressures. When biofeedback intervention types were classified into two types,

simple biofeedback and relaxation-assisted biofeedback, only the relaxation-assisted

biofeedback significantly decreased both systolic and diastolic blood pressures (p <

0.05) compared with those in sham or non-specific behavioral intervention controls.

Rau, Bührer and Weitkunat (2003) investigated whether biofeedback of

the R-wave-to-pulse interval, a measure related to the pulse wave velocity, enabled

participants with either high or low arterial blood pressure to modify their blood

pressure. Twelve participants with high blood pressure (mean systolic blood pressure =

142.6 +/- 13.5 mmHg; mean diastolic blood pressure = 99.9 +/- 12.3 mmHg) and 10

participants with low blood pressure (mean systolic blood pressure = 104.8 +/- 6.6

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mmHg; mean diastolic blood pressure = 73.2 +/- 4.2 mmHg) received 3 individual

sessions of RPI biofeedback within a 2-week period. Participants with high blood

pressure were rewarded for decreasing and participants with low blood pressure for

increasing their blood pressure. Standard arm-cuff blood pressure measurements across

the sessions served as dependent variables. Participants with high blood pressure

achieved significant reductions of systolic (15.3 mmHg) and diastolic (17.8 mmHg)

blood pressure levels from the beginning of the first to the end of the last training

session. In contrast, participants with low blood pressure achieved significant increases

in systolic (12.3 mmHg) and diastolic (8.4 mmHg) blood pressure levels.

Linda and Paul (2003) studied a variety of non pharmacologic interventions

in an attempt to discover their use as therapies for these diseases. The literature relating

to the use of biofeedback therapies for hypertension, cardiac arrhythmias, angina

pectoris, cardiac ischemia, myocardial infarction, and Raynaud's phenomenon was

reviewed. They identified that various methods of biofeedback have shown promise in

the treatment or management of several cardiovascular disorders. The number and

types of studies in each of these areas varied widely, but biofeedback was suggested to

be a useful alternative or adjunct to more conventional forms of treatment.

Nakao, Nomura, Shimosawa, Fujita and Kuboki (2000) compared blood

pressure (BP) biofeedback treatment (BF) effects between white-coat hypertension and

essential hypertension. Fifteen white-coat hypertensive out-patients and 23 essential

hypertensive out-patients were randomly assigned to groups A or B. Subjects in group

A underwent BF once a week for a total of four sessions. Those in group B visited the

clinic only to measure BP and later underwent the same BF. In group A, BPs of white-

coat hypertensives and essential hypertensives were significantly reduced by 22/11 and

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14/8 mmHg, respectively. In group B, they were unchanged during the same period but

later suppressed by BF. Under BF, elevation of diastolic BP due to mental stress testing

was better suppressed in white-coat hypertensives than in essential hypertensives. This

treatment was effective in both types of hypertension, and pressor response to stress

seems to be important in the differentiated BF effect.

Libo and Arnold (1983) did a follow-up study 1 to 5 years after biofeedback

therapy, involving 58 patients in six diagnostic groups (migraine headache, tension

headache, mixed headache, chronic pain, anxiety, and essential hypertension), revealed

that 86% of the patients who continued to practice relaxation techniques improved,

while only 50% of those who had stopped practice improved (p=.04). Among the

patients who improved, 91% had continued to practice and only 9% had stopped

practice, while among the patients who did not improve, 63% had continued to practice

and 36% had stopped practice. Patients who were practicing only occasionally, as

needed, or when stressed improved as much as or more than those who practiced

regularly and frequently (i.e., at least weekly): 89% versus 77% improved, respectively

(p=n.s). There was no difference in the occurrence or frequency of relaxation practice

between patients who have been out of therapy 3 to 5 years and those who completed

therapy more recently, or between those who were in brief versus longer-term therapy.

Although continued relaxation practice is significantly related to the maintenance of

long-term improvement, a few patients manage to improve without it, or continue to

practice yet relapse. It also appeared that only occasional relaxation practice after

therapy is sufficient to maintain long-term therapeutic gains.

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Section C: Literature regarding anxiety among hypertensive patients

Aydoğan et al. (2012) examined the frequency of anxiety disorders among

hypertensive patients. 52 primary hypertensive patients followed by Gulhane Military

Medical Akademi (GATA) Internal Medicine Polyclinic were included. Beck Anxiety

Inventory (BAI) was applied and blood pressures were measured in polyclinic

(measured by physician in sitting position) and house measures were recorded. Co-

morbid diseases and drugs used by patients were asked, all data were transferred to

database. 63.46% (n=33) of patients were female and 36.54% (n=19) male. Mean age

was 57.33±15.88 (20-91). The mean systolic blood pressure was detected 137.50±18.79

(110-180) mmHg, while diastolic blood pressure was 79.38±7.71 (60-90) mmHg in

polyclinics. When BAI scores were examined, the average score was found as 14.61 ±

8.80 (3-36) and 25% (n=13) of patients had minimal anxiety, 36.5% (n=19) mild, 25%

(n=13) moderate and 13.5% (n=7) severe anxiety. There wasn’t a statistically

significant difference between BAI scores and blood pressure values at target (p>0.05).

Bajkó et al. (2012) examined the relationship between autonomic nervous

system dysfunction, anxiety and depression in untreated hypertension. 86 newly

diagnosed hypertensive patients and 98 healthy volunteers were included in the study.

The psychological parameters were assessed with Spielberger State-Trait Anxiety

Inventory and Beck Depression Inventory by a skilled psychologist. Autonomic

parameters were examined during tilt table examination (10min lying position, 10min

passive tilt). Heart rate variability (HRV) was calculated by autoregressive methods.

Baroreflex sensitivity (BRS) was calculated by non-invasive sequence method from the

recorded beat to beat blood pressure values and RR intervals. Significantly higher state

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(42.6±9.3 vs. 39.6±10.7 p=0.05) and trait (40.1±8.9 vs. 35.1±8.6, p<0.0001) anxiety

scores were found in the hypertension group. There was no statistically significant

difference in the depression level. LF-RRI (Low Frequency-RR interval) of HRV in

passive tilt (377.3±430.6 vs. 494.1±547, p=0.049) and mean BRS slope (11.4±5.5 vs.

13.2±6.4, p=0.07) in lying position were lower in hypertensives. Trait anxiety score

correlates significantly with sympatho/vagal balance (LF/HF-RRI) in passive tilt

position (Spearman R=-0.286, p=0.01).

Rafanelli, Offidani, Gostoli and Roncuzzi (2012) aimed to assess clinical

and subclinical distress, psychosocial aspects and psychological well-being in treated

hypertensive patients and to evaluate the psychosocial variables associated with higher

levels of blood pressure according to guidelines for hypertension management. A

consecutive series of 125 hypertensive patients were evaluated using both self- and

observer-rated reliable measures. Generalized anxiety disorder, minor depression,

demoralization and alexithymia were the most frequent diagnoses. Cluster analysis

revealed an association of three distinct symptomatological groups such as the Anxiety-

Depression, the Alexithymia and the Somatization groups, with different levels of

hypertension. Patients with moderate to severe hypertension were more frequently in

the Anxiety-Depression and the Alexithymia groups, whereas the Somatization cluster

has been shown to be associated with isolated systolic hypertension.

Chiaie et al. (2011) investigated the nature of the association between

hypertension and subsyndromal depression in hospitalized hypertensive patients.196

hypertensive and 96 non hypertensive inpatients underwent a SCID interview, to

exclude patients positive for any Axis I or Axis II diagnosis. Symptomatic

32

Subsyndromal Depression (SSD) was identified according to criteria proposed by Judd.

Psychopathological assessment was performed with Anxiety Sensitivity Index (ASI)

and Hopkins Symptom Checklist-90 (SCL-90). Clinical assessments included blood

pressure measurement, evaluation of general health conditions and screening

cardiovascular risk factors (smoke, alcohol, body weight, sedentary life style).

Hypertensives met more frequently criteria for SSD. They also scored higher on ASI

and SCL-90.

Saboya, Zimmermann and Bodanese (2010) aimed to test the hypothesis

that arterial hypertension can be associated with anxiety and depressive symptoms and

to verify its effect on the quality of life. A controlled cross-sectional study included 302

patients (152 hypertensive and 150 normotensive) outpatients at a selected hospital.

Measurements were made in individual interviews and included data collection and

application of general scales such as State-Trait Anxiety Inventory (STAI), Beck

Depression Inventory (BDI), and Medical Outcome Study Short Form, General Health

Survey (SF-36).Anxiety was significantly associated with SAH only after adjusted for

relevant risk factors (odds ratio (OR) = 2.83, 95% confidence interval (CI) = 1.55 to

5.18). Depressive symptoms were significantly associated with SAH (OR) = 4.34 (95%

CI: 2.34 to 8.06). A significant association between quality of life and SAH were also

found and the effect of depressive symptoms, in particular, and anxiety, in the

worsening of quality of life.

Hamer, Batty, Stamatakis and Kivimaki (2010) in a representative study of

33 105 adults (aged 51.7+/-12.1 years; 45.8% men), measured levels of psychological

distress using the 12-item General Health Questionnaire and collected blood pressure,

data on history of hypertension diagnosis, and medication usage. Awareness of

33

hypertension was confirmed through a physician diagnosis or the use of

antihypertensive medication, and unaware hypertension was defined by elevated clinic

blood pressure (systolic/diastolic > or =140/90 mm Hg) without previous treatment or

diagnosis. In comparison with normotensive participants, an elevated risk of distress

(General Health Questionnaire score > or =4) was observed in aware hypertensive

participants (multivariable adjusted odds ratio: 1.57 [95% CI: 1.41 to 1.74]) but not in

unaware hypertensives (odds ratio: 0.91 [95% CI: 0.78 to 1.07]). Antihypertensive

medication and comorbidity were also associated with psychological distress. These

findings suggest that distressed participants were more likely to have low or highly

elevated blood pressure and labeling individuals as hypertensive, rather than having

elevated blood pressure, may partially explain the greater levels of distress in patients

treated for hypertension.

Masmoudi et al. (2010) focussed on the links between the blood pressure

imbalance and some psychosocial factors in a population of ambulatory patients with

hypertension. It was a cross-sectional study on 100 patients with hypertension followed

up in Cardiology in Sfax (Tunisia). Anxiety and depression were assessed by the

Hospital Anxiety and Depression Scale (HADS). Behavioural pattern was evaluated by

a clinical interview, referring to the model of Friedman and Rosenman. They also

collected socio-environmental, clinical, therapeutic and prognostic data. The most

predictive factors of an unbalanced blood pressure were independently: personality

type "A" or unspecified (p = 0002), high fat diet (p = 0026), poor drug adherence (p =

0038) and depression (p = 0015).Several sociodemographic and lifestyle factors are

interrelated and implicated in the blood pressure imbalance, suggesting the need of a

hygienic behavior joining the international recommendations.

34

Joyner, Mount, McCorkle, Simmons, Ferrario and Cline (2009) in response

to almost universally recorded poor blood pressure (BP) control rates, developed a

novel health paradigm model to examine the mindset behind BP control barriers. This

approach, termed patient inertia (PtInert), is defined as an individual's failure to take

responsibility for health conditions and proactive change. Fifty percent of patients

reported slight psychological distress (psychosomatic > anxiety > depression), with

61% possessing hopelessness surrounding complications from high BP no matter their

actions. An unanticipated finding was that patients who had a low reading proficiency

self-reported high levels of hypertension health literacy. Less than half of patients

transferred this health literacy into lifestyle changes in diet, exercise, and medication

adherence. Although patients felt that they could control their BP and frequently

thought about better BP control, 55% of the subjects had uncontrolled hypertension

(>140/90 mm Hg).

Antropova, Osipova, Simonova , Vorob'eva , Pyrikova and Zal'tsman

(2009) elucidated rates of development of arterial hypertension (AH) at working place

(wp), risk factors of cardiovascular diseases (CVD) and anxiety depressive disorders in

persons with professional stress using the Hamilton scale in 138 men (mean age 40.0+/-

1.2 years). Results of the study evidenced for high frequency (46.4%) of development

of AHwp among representatives of stressful occupations. Patients with AHwp have risk

factors of CVD development and total coronary risk comparable with those of patients

with hypertensive disease. Patients with AH have more pronounced anxiety depressive

disorders than healthy subjects.

Han, Yin, Xu, Hong , Liang and Wang (2008) studied the current situation of

depression and anxiety from patients with hypertension as well as to provide reference

35

for the development of control and prevention program. Participants older than 35-year

including both hypertensive patients and healthy controls were randomly selected in 2

communities through Health Behavior Survey. All the subjects were assessed by the

Zung's self-rating depression scale (SDS) and the Zung's self-rating anxiety scale

(SAS).Raw score and index score of SDS and SAS were both significantly (P < 0.01)

greater in hypertensive patients than in healthy control group. The prevalence of

depression of 17.9% and anxiety of 9.5% in patient group were found significantly

higher than that in healthy control group as 11.5% and 4.3%. Data from logistic

regression model analysis showed that depression and anxiety were possible risk

factors of hypertension (OR = 1.677, 95% CI: 1.013-2.776; OR = 2.451, 95% CI:

1.228-4.894). There was a combined effect seen between depression and anxiety (OR =

5.238, 95% CI: 2.356-11.664).

Wei and Wang (2006) investigated incidence and severity of anxiety

symptoms in patients with hypertension. A cross-sectional survey in 891 (432 females)

hypertensive patients was conducted in a regional community. All patients were

interviewed and detailed physical examination was performed. Zung self-rating anxiety

scale (SAS) was used to evaluate the severity of anxiety symptoms. Anxiety was

diagnosed on clinical grounds in 103 patients (11.6%) who also had a raw SAS score of

more than 40. In all subjects surveyed, the average SAS score in females was higher

than males (32.9+/- 7.1 vs 31.2+/-6.4, p < 0.001). The average SAS score was also

higher in patients with hypertension of more than 3 years (32.4+/-7.0 vs 31.2+/-6.1, p =

0.01), in patients with severe hypertension (39.8+/-6.9 vs 29.6 4+/-4.5, p < 0.001), and

in patients with a history of hospitalization for cardiovascular disorders (35.7+/-7.7 vs

31.7+/-6.6, p < 0.001). Multivariate regression analysis showed that female gender,

36

duration of hypertension, and hospitalization history were independent predictors of

anxiety symptoms (p < 0.05).Almost 12% of hypertensive patients have anxiety

symptoms.

Cilli et al. (2007) verified whether hypertensive patients, with recent or old

poor-controlled hypertension, asymptomatic for anxiety and/or depression, seemed

more disturbed in personality than normotensive patients.122 patients with arterial

hypertension and 65 normotensive subjects (37 women, 28 men, middle age 41 +/-

11.7 years) answered two self-extiming questionnaires: A.S.Q. by Krug and Cattel and

C.D.Q. by Krug and Laughlin. 37 hypertensive patients (30.3%) were positive in the

C.D.Q. and 34 (27.8%) in the A.S.Q. test. In the group of normotensive subjects, 13

(20%) were positive in C.D.Q. and 12 (8.4%) in A.S.Q. There was a statistical

difference in C.D.Q and A.S.Q. between hypertensive and normotensive subjects. No

statistical difference was found in C.D.Q. and A.S.Q. between new and old-

hypertensives. The study has shown a significant higher level of anxiety and depression

in hypertensive subjects as compared to normotensives. However, no significant

difference in anxiety and depression levels was found between new- and old-

hypertensive patients or in relation with the use of antihypertensive drugs.

Vetere, Ripaldi, Ais , Korob , Kes and Villamil (2007) determined and

compared prevalence of anxiety disorder among patients with essential hypertension

and a control group. The structured clinical interview (SCID I) was administered

(anxiety disorder module) to 157 people including 57 essential hypertensive patients

(non diabetics, without CVA and or other complications) and 100 controls (non

hypertensive people that converge to the hospital).They observed a higher frequency of

anxiety disorder in the hypertensive group than in the control group (p <0.001).

37

Yasunari , Matsui , Maeda , Nakamura , Watanabe and Kiriike (2006)

examined the hypothesis that anxiety and depression lead to increased plasma

catecholamines and to production of reactive oxygen species (ROS) by mononuclear

cells (MNC) in hypertensive individuals. They also studied the role of BP in this effect.

In Protocol 1, a cross-sectional study was performed in 146 hypertensive patients to

evaluate whether anxiety and depression affect BP and ROS formation by MNC

through increasing plasma catecholamines. In Protocol 2, a 6-month randomized

controlled trial using a subtherapeutic dose of the alpha(1)-adrenergic receptor

antagonist doxazosin (1 mg/day) versus placebo in 86 patients with essential

hypertension was performed to determine whether the increase in ROS formation by

MNC was independent of BP. In Protocol 1, a significant relationship was observed

between the following: trait anxiety and plasma norepinephrine (r = 0.32, P < .01);

plasma norepinephrine and ROS formation by MNC (r = 0.36, P < .01); and plasma

norepinephrine and systolic, diastolic, and mean BP (r = 0.17, P = .04; r = 0.26, P = .02;

r = 0.23, P < .01, respectively). In Protocol 2, subtherapeutic doxazosin treatment (1

mg/day) had no significant effect on BP.

Vicario, Martinez, Baretto, Diaz Casale and Nicolosi (2005) studied sixty

hypertensive patients, aged 65-80 years, compared with 30 normotensive individuals

for recall scores. Neither gender differences, duration of hypertension (10.2+/-8.2

years), nor prescribed antihypertensive drug treatment had an influence on study

results. Immediate recall was impaired in both groups. The hypertensive patients

evinced impairment in all tests vs. the normotensive subjects. Mean deferred recall

scores +/- SD were 5.68+/-2.6 vs. 7.13+/-2.4; p<0.01. Deficits in attention speed and

executive function, as measured by non-performance on the Trail Making Test Part B,

38

were present in 46% of hypertensive patients vs. 13% of normotensive patients

(p<0.005), with more errors made by the hypertensive patients (1.15+/-1.54 vs. 0.46+/-

0.9; p<0.02). Scores on the Stroop Color and Word Test also revealed deficits in the

hypertensive patients (24.7+/-7.6 vs. 32+/-10.7; p<0.005). Compared with the control

group, the hypertensive participants revealed more deficits in skills involving delayed

recall and prefrontal-region skills.

Section D: Cognitive behaviour therapy for the anxiety triad.

Sarris et al. (2012) did a meta review with an objective to examine evidence

across a broad range of CAM and lifestyle interventions in the treatment of anxiety

disorders. In early 2012 they conducted a literature search of PubMed, Scopus,

CINAHL, Web of Science, PsycInfo, and the Cochrane Library, for key studies,

systematic reviews, and meta analyses in the area. The paper found that in respect to

treatment of generalized anxiety or specific disorders, CAM evidence revealed current

support for the herbal medicine Kava. One isolated study shows benefit for

naturopathic medicine, whereas acupuncture, yoga, and Tai chi have tentative

supportive evidence, which is hampered by overall poor methodology. The breadth of

evidence does not support homeopathy for treating anxiety. It was also identified that

strong support existed for lifestyle modifications including adoption of moderate

exercise and mindfulness meditation, whereas dietary improvement, avoidance of

caffeine, alcohol, and nicotine offer encouraging preliminary data. In conclusion,

certain lifestyle modifications and some CAMs may provide a beneficial role in the

treatment of anxiety disorders.

39

Chen et al. (2012) screened over 1,000 abstracts and reviewed 200+ full

articles. Only randomized controlled trials were included. The Boutron checklist to

evaluate a report of a non pharmaceutical trial (CLEAR-NPT) was used to assess study

quality; 90% of the authors were contacted for additional information. Review Manager

5 was used for meta-analysis. A total of 36 RCTs were included in the meta-analysis

(2,466 observations). Most RCTs were conducted among patients with anxiety as a

secondary concern. Twenty-five studies reported statistically superior outcomes in the

meditation group compared to control. No adverse effects were reported. This review

demonstrates some efficacy of meditative therapies in reducing anxiety symptoms,

which has important clinical implications for applying meditative techniques in treating

anxiety.

Bystritsky et al. (2012) examined a large sample of patients with anxiety and

the association between types of complementary and alternative treatments that were

used, demographic variables, diagnostic categories, and treatment outcomes.

Interviewer-administered questionnaires via a centralized telephone survey by blinded

assessment raters. The interviews were done at baseline, 6, 12, and 18 months of the

study. A total of 1004 adults ages 18-75 who met DSM-IV criteria for Generalized

Anxiety Disorder (GAD), Panic Disorder, Social Anxiety Disorder, or Post-Traumatic

Stress Disorder. They assessed medication/herbal use, the use of any alternative

therapies, and combined Complementary and Alternative Medicine (CAM) use. They

found an extensive (43%) use of a variety of CAM treatments that is consistent with

previous study results in populations with anxiety. Users most often had a diagnosis of

GAD, were older, more educated, and had two or more chronic medical conditions.

40

Chung , Brooks , Rai , Balk and Rai (2012) investigated the effect of Sahaja

yoga meditation on quality of life, anxiety, and blood pressure control. The prospective

observational cohort study enrolled two study groups: (meditation group) and (control

group). Researchers measured quality of life, anxiety, and blood pressure before and

after treatment. Sixty-seven (67) participants in the meditation group and 62

participants in the control group completed the study. The two groups were comparable

in demographic and clinical characteristics. At baseline, the meditation group had

higher quality of life (p<0.001) than controls but similar anxiety level (p=0.74) to

controls. Within-group pre- versus post-treatment comparisons showed significant

improvement in quality of life, anxiety, and blood pressure in the meditation group

(p<0.001), while in controls, quality of life deteriorated and there was no improvement

in blood pressure. The improvement in quality of life, anxiety reduction, and blood

pressure control was greater in the meditation group.

Ko, Lin (2012) aimed to investigate the effect of a relaxation tape on levels of

anxiety in surgical patients with a one-group pretest-post-test quasi-experimental

design. The patients were given relaxation tapes the day before their scheduled surgery.

Tests were conducted before and after patients listened to the tapes. STAI and

respiration, pulse and blood pressure were used to collect data measurements on the

anxiety level of these patients. The average age of 80 patients was 43·14 (SD 17·27)

years. After the patients listened to the relaxation tape, their respiration rate dropped

from 18·4 (SD 6·9) -17·8 (SD 7·4), pulse rate dropped from 81·9 (SD 33·5) - (SD

33·7), systolic blood pressure decreased from 125·4 (SD 16) mmHg - 121·5 (SD 13·4)

mmHg and STAI score dropped from 50·9 (SD 11·1) - 41·1 (SD 9·8). They all showed

a significant level of difference (p < 0·05). The results showed that a relaxation tape

41

can significantly reduce the level of anxiety and vital signs related to anxiety in surgical

patients.

Busch, Magerl, Kern, Haas, Hajak and Eichhammer (2012) in order to

disentangle the effects of relaxation and respiration, investigated two different DSB

techniques at the same respiration rates and depths on pain perception, autonomic

activity, and mood in 16 healthy subjects. In the attentive DSB intervention, subjects

were asked to breathe guided by a respiratory feedback task requiring a high degree of

concentration and constant attention. In the relaxing DSB intervention, the subjects

relaxed during the breathing training. The skin conductance levels, indicating

sympathetic tone, were measured during the breathing maneuvers. Thermal detection

and pain thresholds for cold and hot stimuli and profile of mood states were examined

before and after the breathing sessions. The mean detection and pain thresholds showed

a significant increase resulting from the relaxing DSB, whereas no significant changes

of these thresholds were found associated with the attentive DSB. The mean skin

conductance levels indicating sympathetic activity decreased significantly during the

relaxing DSB intervention but not during the attentive DSB. Both breathing

interventions showed similar reductions in negative feelings (tension, anger, and

depression). Results suggested that the way of breathing decisively influences

autonomic and pain processing, thereby identifying DSB in concert with relaxation as

the essential feature in the modulation of sympathetic arousal and pain perception.

Reinecke, Hoyer, Rinck and Becker (2012) investigated whether generalized

anxiety disorder (GAD) is susceptible to cognitive-behavioural treatment (CBT). 22

GAD patients and 22 healthy controls (HC) were tested twice within 15 weeks, with

patients receiving CBT in between. A subset of patients was additionally tested while

42

waiting for treatment to control for retest effects. Using a mental control paradigm, they

measured intrusion frequency during the voluntary suppression of thoughts related to

(a) the individual main worry topic, (b) a negative non-worry topic, and (c) a neutral

topic. Self-reported worry was measured before and after treatment, and at 6-months

follow-up. Compared to HC, GAD showed specifically more worry-related intrusions.

CBT reduced this bias to a healthy level, over and above mere test-retest effects.

Norton and Barrera (2012) conducted a randomized clinical trial examining

the efficacy of a 12-week trans diagnostic cognitive- behavioral group treatment in

comparison to 12-week diagnosis-specific group Cognitive-Behavioral Therapy (CBT)

protocols for panic disorder, social anxiety disorder, and generalized anxiety disorder.

Results from 46 treatment initiators suggested significant improvement during

treatment, strong evidence for treatment equivalence across transdiagnostic and

diagnosis-specific CBT conditions, and no differences in treatment credibility. This

study provided evidence supporting the efficacy of transdiagnostic CBT by comparison

to current gold-standard diagnosis-specific CBT for social anxiety disorder, generalized

anxiety disorder, and panic disorder.

Hedman, Andersson, Lindefors, Andersson, Rück and Ljótsson (2012)

investigated the cost-effectiveness and 1-year treatment effects of ICBT for severe

health anxiety. Cost-effectiveness and 1-year follow-up data were obtained from a

randomized controlled trial comparing ICBT (n=40) to an attention control condition

(CC, n=41). The primary outcome measure was the Health Anxiety Inventory (HAI). A

societal perspective was taken and incremental cost-effectiveness ratios (ICERs) were

calculated using bootstrap sampling. Baseline to 1-year follow-up effect sizes on the

43

primary outcome measure were large (d=1.71-1.95). ICBT is a cost-effective treatment

for severe health anxiety that can produce substantial and enduring effects.

Cutshall et al. (2011) assessed whether a self-directed, computer-guided

meditation training program is useful for stress reduction in hospital nurses. They

prospectively evaluated participants before and after a month-long meditation program.

The meditation program consisted of 15 computer sessions that used biofeedback to

reinforce training. Participants were instructed to practice the intervention for 30

minutes per session, four times a week, for four weeks. Visual analogue scales were

used to measure stress, anxiety, and quality of life (assessments were performed using

Linear Analogue Self-Assessment [LASA], State Trait Anxiety Inventory [STAI], and

Short-Form 36 [SF-36] questionnaires). Differences in scores from baseline to the

study's end were compared using the paired t test. Eleven registered nurses not

previously engaged in meditation were enrolled; eight completed the study. Intent-to-

treat analysis showed significant improvement in stress management, as measured by

SF-36 vitality subscale (P = .04), STAI (P = .03), LASA stress (P = .01), and LASA

anxiety (P = .01). Nurses were highly satisfied with the meditation program, rating it

8.6 out of 10.The results of this pilot study suggest the feasibility and efficacy of a

biofeedback-assisted, self-directed, meditation training program to help hospital nurses

reduce their stress and anxiety. Optimal frequency of use of the program, as well as the

duration of effects, should be addressed in future studies.

Sherman et al. (2010) evaluated the effectiveness of therapeutic massage for

persons with generalized anxiety disorder (GAD).Sixty-eight persons with GAD were

randomized to therapeutic massage (n=23), thermotherapy (n=22), or relaxing room

therapy (n=23) for a total of 10 sessions over 12 weeks. Mean reduction in anxiety was

44

measured by the Hamilton Anxiety Rating Scale (HARS). Secondary outcomes

included 50% reduction in HARS and symptom resolution of GAD, changes in

depressive symptoms (Patient Health Questionnaire (PHQ-8)), worry and GAD-related

disability. They compared changes in these outcomes in the massage and control

groups posttreatment and at 6 months using generalized estimating equation (GEE)

regression. All groups had improved by the end of treatment (adjusted mean change

scores for the HARS ranged from -10.0 to -13.0; P<.001) and maintained their gains at

the 26-week followup. Massage was not superior to the control treatments, and all

showed some clinically important improvements, likely due to some beneficial but

generalized relaxation response.

Bertisch, Wee, Phillips and McCarthy (2009) analyzed data on MBT use

from the 2002 National Health Interview Survey Alternative Medicine Supplement

(n=31,044). MBT included relaxation techniques (deep breathing exercises, guided

imagery, meditation, and progressive muscle relaxation), yoga, tai chi, and qigong. To

identify medical conditions associated with use of MBT overall and of individual MBT,

they used multivariable models adjusted for socio-demographic factors, insurance

status, and health habits. Among users of MBT (n=5170), they assessed which medical

conditions were most frequently treated with MBT, additional rationale for using MBT,

and perceived helpfulness. They found a positive association between MBT use and

several medical conditions including various pain syndromes and anxiety/depression.

Among adults using MBT to treat specific medical conditions, MBT was most

commonly used for anxiety/depression and musculoskeletal pain syndromes. More than

50% of respondents used MBT in conjunction with conventional medical care, and

20% used MBT for conditions they thought conventional medicine would not help.

45

Bradt and Dileo (2009) tried to examine the effects of music interventions with

standard care versus standard care alone on psychological and physiological responses

in persons with CHD. They searched the Cochrane Central Register of Controlled

Trials (CENTRAL), MEDLINE, CINAHL, EMBASE, PSYCINFO, LILACS, Science

Citation Index, www.musictherapyworld.net, CAIRSS for Music, Proquest Digital

Dissertations, ClinicalTrials.gov, Current Controlled Trials, and the National Research

Register (all to May 2008). They hand searched music therapy journals and reference

lists, and contacted relevant experts to identify unpublished manuscripts. They included

all randomized controlled trials that compared music interventions and standard care

with standard care alone for persons with CHD. Data were extracted, and

methodological quality was assessed, independently by the two reviewers. Twenty-

three trials (1461 participants) were included. Music listening was the main

intervention used, and 21 of the studies did not include a trained music therapist.

Results indicated that music listening has a moderate effect on anxiety in patients with

CHD, however results were inconsistent across studies.

Singh et al. (2009) aimed to evaluate the acute effects of music and progressive

muscle relaxation (PMR) in hospitalized COPD subjects after a recent episode of

exacerbation. A Randomized controlled study was performed of pre-test post-test

design after recruiting 82 COPD subjects from K.M.C hospitals. All patients were

admitted for acute exacerbation and were medically stabilized. After being screened for

the inclusion and exclusion criteria, 72 subjects were selected for the study. Music

group listened to a self selected music of 60-80 beats per minute for 30 minutes. PMR

group practiced relaxation through a pre-recorded audio of instructions of 16 muscle

groups. Outcome variables were Spielberger's state anxiety inventory (SSAI),

46

Spielberger's trait anxiety inventory (STAI), dyspnea, systolic blood pressure (SBP),

diastolic blood pressure (DBP), pulse rate (PR) and respiratory rate (RR). There was

statistically significant main effect across the sessions for state anxiety (F = 62.621, p =

0.000), trait anxiety (F = 19.528, p = 0.000), dyspnea (F = 122.227, p = 0.000), SBP (F

= 63.885, p = 0.000), PR (F = 115.780, p = 0.000) and RR (F = 202.977, p = 0.000).

There was statistically significant interaction effect between the two groups for state

anxiety (F = 6.024, p = 0.003), trait anxiety (F = 8.222, p = 0.000), dyspnea (F =

10.659, p = 0.000), SBP (F = 12.889, p = 0.000), PR (F = 4.746, p = 0.008) and RR (F

= 12.078, p = 0.000). Music and PMR are effective in reducing anxiety and dyspnoea

along with physiologic measures such as SBP, PR and RR in two sessions in COPD

patients hospitalized with exacerbation. However, reductions in the music group were

greater compared to the PMR group.

Yook et al. (2008) examined the usefulness of a mindfulness-based cognitive

therapy (MBCT) for treating insomnia symptoms in patients with anxiety disorder.

Nineteen patients with anxiety disorder were assigned to an 8-week MBCT clinical

trial. Participants showed significant improvement in Pittsburgh Sleep Quality Index (Z

= -3.46, p = 0.00), Penn State Worry Questionnaire (Z = -3.83, p = 0.00), Ruminative

Response Scale (Z = -3.83, p = 0.00), Hamilton Anxiety Rating Scale (Z = -3.73, p =

0.00), and Hamilton Depression Rating Scale scores (Z = -3.06, p = 0.00) at the end of

the 8-week program as compared with baseline. Multiple regression analysis showed

that baseline Penn State Worry Questionnaire scores were associated with baseline

Pittsburgh Sleep Quality Index scores. These findings suggest that MBCT can be

effective at relieving insomnia symptoms by reducing worry associated sleep

disturbances in patients with anxiety disorder.

47

Evans, Ferrando, Findler, Stowell, Smart and Haglin (2008) recruited

eligible subjects to a major academic medical center participated in the group MBCT

course and completed measures of anxiety, worry, depressive symptoms, mood states

and mindful awareness in everyday life at baseline and end of treatment. Eleven

subjects (six female and five male) with a mean age of 49 (range=36-72) met criteria

and completed the study. There were significant reductions in anxiety and depressive

symptoms from baseline to end of treatment. MBCT may be an acceptable and

potentially effective treatment for reducing anxiety and mood symptoms and increasing

awareness of everyday experiences in patients with GAD.

Section E: Literature regarding biofeedback on anxiety

Prinsloo, Rauch, Karpul and Derman (2013) examined the effect of heart rate

variability (HRV) biofeedback on measures of electroencephalogram (EEG) during and

immediately after biofeedback. Eighteen healthy males exposed to work-related stress,

were randomised into an HRV biofeedback (BIO) or a comparative group (COM). EEG

was recorded during the intervention and during rest periods before and after the

intervention. Power spectral density in theta, alpha and beta frequency bands and

theta/beta ratios were calculated. During the intervention, the BIO group had higher

relative theta power [Fz and Pz (p < 0.01), Cz (p < 0.05)], lower fronto-central relative

beta power (p < 0.05), and higher theta/beta [Fz and Cz (p < 0.01), Pz (p < 0.05)] than

the COM group. The findings of this study suggested that a single session of HRV

biofeedback after a single training session was associated with changes in EEG

suggestive of increased internal attention and relaxation both during and after the

intervention.

48

Wells, Outhred, Heathers, Quintana and Kemp (2012) studied a total of 46

trained musicians and were randomly allocated to a slow breathing with or without

biofeedback or no-treatment control group. A 3 Group×2 Time mixed experimental

design was employed to compare the effect of group before and after intervention on

performance anxiety (STAI-S) and frequency domain measures of HRV. Slow

breathing groups (n=30) showed significantly greater improvements in high frequency

(HF) and LF/HF ratio measures of HRV relative to control (n=15) during 5 minute

recordings of performance anticipation. Participants with high baseline anxiety who

received the intervention (n=15) displayed greater reductions in self-reported state

anxiety relative to those in the control condition (n=7) (r=0.379). These findings

indicated that slow breathing was particularly helpful for musicians with high levels of

anxiety.

Ratanasiripong, Ratanasiripong and Kathalae (2012) assessed 60 second-

year baccalaureate nursing students. The 30 participants in the biofeedback group were

given training on how to use the biofeedback device to assist in stress and anxiety

management for 5 weeks while the 30 in the control group did not receive any training.

Results indicated that the biofeedback group was able to maintain the stress level while

the control group had a significant increase in the stress level over the 5-week period of

clinical training. Additionally, the biofeedback group had a significant reduction in

anxiety, while the control group had a moderate increase in anxiety.

Sutarto, Wahab and Zin (2012) conducted a study to examine the effect of

resonant breathing biofeedback training for reducing stress among manufacturing

operators. Thirty-six female operators from an electronic manufacturing factory were

randomly assigned as the experimental group (n = 19) and the control group (n = 17).

49

The participants of the intervention received 5 weekly sessions of biofeedback training.

Physiological stress profiles and self-perceived depression, anxiety, and stress scale

(DASS) were assessed at pre- and post-intervention. Results indicated that depression,

anxiety, and stress significantly decreased after the training in the experimental group;

they were supported by a significant increase in physiological measures. Overall, these

results supported the potential application of resonant biofeedback training to reduce

negative emotional symptoms among industrial workers.

Nilsson, Lundh, Faghihi and Roth-Andersson (2011) asked forty socially

anxious participants to give a speech, then to listen to and evaluate a taped recording of

their performance. Half of the sample was given cognitive preparation prior to the

audio feedback and the remainder received audio feedback only. Cognitive preparation

involved asking participants to (1) predict in detail what they would hear on the

audiotape, (2) form an image of themselves giving the speech and (3) listen to the audio

recording as though they were listening to a stranger. To assess generalization effects

all participants were asked to give a second speech. Audio feedback with cognitive

preparation was shown to produce less negative ratings after the first speech, and

effects generalized to the evaluation of the second speech. More positive speech

evaluations were associated with corresponding reductions of state anxiety. Social

anxiety as indexed by the Implicit Association Test was reduced in participants given

cognitive preparation.

Mikosch et al. (2010) conducted a study to evaluate the value of psychological

assistance including respiratory-sinus-arrhythmia biofeedback training in its ability to

reduce the level of anxiety in patients undergoing coronary angiography. 212 patients

50

undergoing routine elective coronary angiography for the evaluation of stable coronary

artery disease were randomized into two groups. In the psychological support group (n

= 106) a structured psychological conversation and respiratory-sinus-arrhythmia

biofeedback training were offered prior to coronary angiography. In the control group

(n = 106) standard care and information was provided without psychological support.

State-anxiety was measured (scale 20-80) 1 day prior to and after coronary

angiography, along with blood pressure and heart rate. Prior to coronary angiography,

state-anxiety was 54.8 +/- 11.5 (mean +/- SD) in the control group and 54.8 +/- 12.6 in

the psychological support group. After coronary angiography, state-anxiety was 47.9

+/- 18.5 in the control group but 28.3 +/- 12.5 in the psychological support group

(Wilcoxon rank sum test W = 7272, P < 0.001). Blood pressure was significantly lower

in the psychological support group prior to the intervention and the day after coronary

angiography.

Rodebaugh, Heimberg , Schultz and Blackmore (2010) tested video feedback

with cognitive preparation among treatment-seeking participants with a primary

diagnosis of social anxiety disorder. In Session 1, participants gave an extemporaneous

speech and either received the intervention or not. In Session 2, 6-14 days later,

participants gave a second extemporaneous speech. The intervention improved self-

perception of performance, particularly for those participants with the most

unrealistically negative impressions of their performance (i.e., high self-observer

discrepancy). In addition, the intervention reduced anticipatory anxiety for the second

speech for participants with high self-observer discrepancy. These findings suggested

that the intervention may be useful for people with social anxiety disorder and higher

self-observer discrepancies for a specific task.

51

Henriques, Keffer, Abrahamson and Horst (2011) explored the effectiveness

of a computer-based heart rate variability biofeedback program on reducing anxiety and

negative mood in college students. A pilot project (n = 9) of highly anxious students

revealed sizable decreases in anxiety and negative mood following utilizing the

program for 4 weeks. A second study (n = 35) employing an immediate versus delayed

treatment design replicated the results, although the magnitude of the impact was not

quite as strong.

Bhat (2010) carried out a study in multispecialty Command Hospital by

enrolling 100 patients with psychiatric diagnosis from both inpatient and outpatient

services. The anxiety level was assessed clinically and by using Hamilton Anxiety

Scale and Taylor's Manifest Anxiety Scale. One group of 50 patients was treated with

Alfa EEG biofeedback sessions only, 5 times in a week for 8 weeks, along with specific

pharmacotherapy. The other group was treated with appropriate dose of anxiolytics.

The anxiety level was reassessed after 4 weeks and 8 weeks. The response was better

for mixed anxiety and depressive disorder with pharmacotherapy than with the

biofeedback, but female patients showed better response with EEG biofeedback. Alfa

EEG biofeedback therapy was almost as efficacious as pharmacological intervention in

the management of anxiety symptoms, and relatively more useful in females.

Reiner (2008) examined the effectiveness of a portable Respiratory Sinus

Arrhythmia (RSA) biofeedback device as an adjunct to CBT in persons with anxiety

disorders and other disorders associated with autonomic dysfunction attending

outpatient treatment. Participants were 24 individuals attending outpatient cognitive

behavioural treatment for a range of anxiety disorders. Participants were assessed over

a 3 week period. Outcomes included measures of anxiety (STAI-Y), sleep disturbances

(PSQI), anger (STAEI), and subjective questions about the effectiveness of the device

52

as a treatment adjunct. Significant reductions were found for anxiety and anger and for

certain sleep variables (e.g. sleep latency). There was a significant dose-effect in that

those who were more compliant had significantly greater reductions in most domains

including sleep, anger and trait anxiety. These results suggested that portable RSA

biofeedback was a promising treatment adjunct for disorders of autonomic arousal and

is easily integrated into treatment

Michael, Krishnaswamy and Mohamed (2005) tried to establish the

effectiveness of EEG biofeedback using beta training as a relaxation technique and

ultimately reducing anxiety levels of patients with confirmed unstable angina or

myocardial infarction. Patients with confirmed unstable angina or myocardial infarction

referred by cardiologists were recruited 2-3 days after their cardiac event from the

cardiology wards. Their initial anxiety scores were determined using the Hospital

Anxiety and Depression Scale. Those that returned for therapy underwent instrument

feedback training using EEG every two weeks for a total of five sessions. EEG

frequencies were measured for all sessions. Dropouts who did not participate in the

program agreed to return 3 months later for the second psychological assessment. The

study design was uncontrolled. Subjects had significantly lower anxiety scores at the

second screening (p < 0.001), while the dropouts had significantly higher scores (p <

0.001). Beta training was effective in increasing sensory motor rhythm (SMR) waves

but no significant effect was present for the alpha waves.

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3.2 CONCEPTUAL FRAMEWORK

Health is described as a positive state of well being in which a person is

productive to his maximum level. He sustains his effort to maintain this state and

contribute to the wellness of his co-beings and society. The concept of health is also

accepted as a complex interaction of personal, environmental, psychological and

social factors. Chummun (2009) has implied that patients with arterial hypertension

require support to adhere successfully to their prescribed therapeutic regimen, and

nurses have the leading role in providing relevant information to encourage the

empowerment of patients with this disease. After exploring various theoretical

contexts, the investigator opted for Nola J Pender’s Modified Health Promotion

Model (1996) as means to guide the patients with hypertension. Nola J Pender is the

theorist who described and emphasized the importance of contributing factors to a

person’s health and his commitment to maintain and promote healthy behaviour.

The major concepts covered in the model are

Individual characteristics

Behaviour specific cognitions and affect

Behaviour outcomes

Individual characteristics are personal elements which are non- modifiable

or modifiable and has a positive health outcome. They include demographic

characteristics, personality traits, health behaviours, and willingness to adopt and

sustain healthy behaviours, personal inclination to one’s own health and

commitment to the well being of the society.

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Aspects such as age, sex, BMI, FBS, cholesterol levels, smoking /

alcoholism, physical activity and lifestyle, menopause, dietary pattern,

antihypertensive medications and doses etc. play a role in the level of blood pressure

of an individual. Blood pressure level is also influenced by psychological factors like

anxiety (state and trait), perception on health, perceived health status and self

motivation to practice life style modifications. Socio- cultural background of the

patients constituted by educational status, area of residence, monthly income, type of

family and social support also exert an effect on blood pressure.

Behaviour specific cognitions and affect describe the way an individual

mentally process a selected input and his ability to translate that cognitive process

into an action. Numerous factors may influence a behaviour of an individual in

relation to a mental concept. One’s understanding of the possible benefits in

practicing a particular action, perception of the possible hindrances to continue the

behaviour if he chooses to pursue it, self confidence to sustain the action even in the

absence of hindrances and ability to overcome any negative feelings or setbacks

after he started up are examples of cognitive process. Cognition and related affect

are also influenced by modifying factors like situational and interpersonal elements.

This is a fitting concept because human being can be best influenced by a peer, a

professional or media as is he a social being, constantly in interaction with

surroundings.

The subcomponents identified for this selected group of patients in the

cognitive-affective aspect are perceived health status, perceived self efficacy,

perceived barriers to action, activity related affect and modifying factors.

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Perceived health status

A known hypertensive patient’s awareness about the disease, drug

compliance and follow-up, dietary restrictions etc. are assumed to be adequate since

they are well-informed by the consulting physician. But most of the patients are

unaware of the possible benefits of a relaxation therapy. So apart from the routine

care, the investigator impart knowledge and skill on abdominal breathing and

biofeedback over a period of one month with four learning sessions. This is followed

by a schedule of relaxation at home (20 minutes every day and noting down the time

of practice in the diary provided). The learning sessions are supplemented by once a

month reinforcement for three times. The intervention includes fortnightly telephonic

reminders to the study group patients. The effect of the intervention is assessed at the

end of first, second and third month of selecting the patient. The benefits of the

intervention like lowering of blood pressure and anxiety, prevention of complications,

reduction of dose of medications and thus lesser cost of treatment are also explained

to the patient.

Perceived self- efficacy

Patients are helped to identify a time slot suitable for practice of relaxation at

home after their daily choirs. They are guided to stick on to the same timing everyday

to establish a routine. The participants clarify their doubts from the investigator as

needed to improve their practice.

Perceived barriers to action

Out patients commonly present with difficulty to report for follow-up on

scheduled days because of their domestic commitments or other planned

appointments. It is expected that the participants are resourceful to overcome such

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difficulties by making necessary changes in the schedule with the investigator’s help.

The investigator has planned to accommodate the patients who report one or two days

before or after the schedule by relaxing the reporting days for a short period

Activity related affect

Patients experience relaxation, better energy levels and calmness after the

intervention . This will motivate them to carry on further. The interested participants

are the low defaulters. The patients who feel that the intervention schedule is difficult

or who have hesitation will get more frequent telephonic reinforcement to continue in

the study.

Modifying factors

Interpersonal influences

In the health context, the major figure who influences a patient is the

consulting physician. The nurse investigator also motivate on medication compliance,

life style modification, relaxation therapy and regular follow-up. Media and peers as

well inspire the participants. In this study, an immediate family member is assigned to

motivate the patient to adhere to the relaxation plan at home. It is also assumed that

the scheduled telephone reinforcement will improve the adherence to the relaxation

practice.

Situational influences

The environment of the intervention room is maintained noise-free and non-

distracting. The objective evidence of relaxation (the number of green lines appearing

on the screen of biofeedback machine) motivates the patient to relax better and to

maintain the relaxation at the desired level for long. At home, the patient is instructed

to be calm, in clean dress in a clean room preferably with shut doors and recollect the

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level of relaxation achieved with the machine. These make the exercise a pleasurable

one at home.

Behavioural outcome is the final concept described in this theory. The

outcomes can be as desired or anything less than that. The likelihood of any of these

options depend on selected elements like immediate commitment to plan of action

and competing demands/ preferences. Commitment encompasses the readiness to

follow reminders and scheduled follow ups, regular home practice, interaction with

health professionals etc. Competing preferences/ demands are two sets of situations

on which the person has good control or least control in spite of his commitments to

action.

Commitment to a plan of action

The patient is helped to hold on to the intervention plan, drug compliance,

interaction with medical personnel, and regular follow-up (for reassessment and

reinforcement), daily home practice and reminders to achieve the best results.

Telephonic reinforcement and pre-scheduled follow-up days help the patients to

remain committed .

Immediate competing demands and preferences

Some of the patients can not comply with the intervention schedule fully,

though they are well motivated. Such situations include travelling to far places, family

functions and rarely running out of fund to buy medications etc. Patients can

compensate for these situations by making alternate feasible timings and being more

adherent to the life style modifications.

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Health promoting behaviours

They are the endpoints or actions directed towards attaining positive health

outcome such as optimal well-being, personal fulfilment, and productive living. The

positive outcomes expected in the study are lowered blood pressure, less anxiety, dose

reductions of antihypertensive medications, and fewer hospitalisations for

hypertension related complications. It is assumed that patients with hypertension will

positively adhere to life style modifications and the relaxation therapy to effect

desired health outcomes.

Non modifiable

factors

Age, Sex, Area of

residence, Education,

Income per month,

Social support,

Menopausal status

Type of personality

Modifying factors

- Interpersonal influences:

Physician advices,

Support/motivation from

family for regular medications,

nutrition advice by medical

personnel, BART intervention

(over four weeks) & telephonic

reminders from investigator

- Situational influences:

Evidence of relaxation from

BF machine, Conducive home

environment & reinforcements

Modifiable factors

BMI, Cholesterol

level, FBS level,

Duration of

hypertension,

Physical activity style,

Alcoholism/ Smoking

Anxiety level

Anti hypertensive

medicines

Cognitive perceptual factors

Benefits: Better BP control, Less

medicines and complications

Barriers: Time constraints, Lack of

motivation, Social commitments,

Cost of commute

Self efficacy: Confidence for daily

practice, Thorough with relaxation

Activity related affect: Feel relaxed

/ calm, Better energy levels

Health promoting

behaviour

Study group

Better BP control

Less anxiety

Dose reductions of

antihypertensive

medications

Less hospitalisations Reduced cost of treatment Control group

No significant change in

Blood Pressure,

Variable levels of

anxiety,

No significant

dose reductions,

Possible hospitalisations

for related complications

Commitment to

plan of action

Drug compliance,

Interaction with physician

& investigator, Regular

follow-up for reassessment

and reinforcement (3 times)

Daily home practice,

Accepting phone reminders

Immediate competing demands :

Travel to distances

Social events

Skipping medicines

Lack of fund

Preferences

Finding time for self

Self reminders, Seeking

alternative from investigator

Interaction with Physician

Compensating for missed

follow-up, Dietary

modifications, Physical

exercise

Figure 2: Conceptual frame work based on Nola J. Pender’s Modified Health Promotion Model (1996)

Patients with

Stage I/stage II

hypertension

Study Group/

Control Group

INDIVIDUAL

CHARACTERISTICS BEHAVIOUR SPECIFIC

COGNITIONS AND AFFECT BEHAVIOUR OUTCOMES

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