Complementary Therapies in Clinical Practice xxx (2015) 1e8

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Complementary Therapies in Clinical Practice

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Combination of music with lifestyle modification versus lifestyle

modification alone on blood pressure reduction e A randomized
controlled trial
Kirthana Ubrangala Kunikullaya a, *, Jaisri Goturu a, Vijayadas Muradi a,
Preethi Avinash Hukkeri a, Radhika Kunnavil c, Venkatesh Doreswamy a,
Vadagenahalli S. Prakash b, Nandagudi Srinivasa Murthy d
a
Department of Physiology, M S Ramaiah Medical College and Group of Hospitals, Bangalore, Karnataka, India
b
Department of Cardiology, M S Ramaiah Medical College and Group of Hospitals, Bangalore, Karnataka, India
c
Department of Community Medicine, M S Ramaiah Medical College and Group of Hospitals, Bangalore, Karnataka, India
d
Department of Division of Research and Patents, Gokula Education Foundation, Bangalore, Karnataka, India

a r t i c l e i n f o a b s t r a c t

Article history: Objective: To evaluate the change in blood pressure (BP) after 3 months of music intervention combined
Received 24 February 2015 with lifestyle modifications, in comparison with conventional lifestyle modifications.
Accepted 6 May 2015 Methods: A Prospective randomized control trial was conducted on hundred prehypertensives or stage I
hypertensives who were randomly divided into two groups (n ¼ 50 each). Both the groups were given
Keywords: lifestyle modifications while one had added music intervention (raga bhimpalas) for 3 months. Main
Stage I hypertension
outcome measures were 24 h ambulatory BP monitoring, stress levels, and biomarkers of hypertension.
Prehypertension
Results: Mean (SD) of diastolic BP (DBP) pre and post intervention were overall ¼ 85.1(6.8) and 83(8.7)
Indian music
24 h ambulatory blood pressure
{P ¼ 0.004}, awake ¼ 87.7(7.6) and 85.9(9.2){P ¼ 0.021}. Regression analysis showed association between
Biomarkers hypertension diastolic BP change and post-intervention stress score in the music intervention group. Significant
change in BP was seen among those who were prehypertensives prior to intervention.
Conclusion: Music decreased DBP and when used as an adjunct benefitted subjects with initial BP in
prehypertension range.
© 2015 Elsevier Ltd. All rights reserved.

1. Introduction passive listening.

Music as a non-pharmacological therapy for hypertension has
Hypertension prevalence is increasing and globally, the number been tried by a few investigators (listening to music, for durations
of hypertensives has been predicted to be 1.56 billion by 2025 [1]. ranging between 10 and 25 min for 1e3 months). Most of the
The Seventh report of the Joint National Committee (JNC VII) has studies have used clinical sphygmomanometric recordings and
indicated lifestyle modifications (weight reduction, dietary modi- shown significant reduction in blood pressure (BP) [4e8]. Effect of
fications, salt restriction and physical activity) and pharmacological music on 24 h ambulatory BP (ABP) measurements, with a pre-
therapy for the management of hypertension [2]. hypertension group and simultaneous measurements of bio-
Non-pharmacological modes aimed at reducing stress and markers of hypertension has not been studied [9e13].
promoting relaxation have been evaluated for the treatment of Raga, a word used to denote musical scale, is a set of musical
hypertension [3]. Listening to music, offers advantages of low cost, notes presented in an orderly manner in order to generate a melody
ease of administration, better compliance and safety. Music can be out of the same, in Indian music. Different ragas have the property
used for stress reduction through active music making, as well as of evoking different emotions among humans (example: raga
Mishra Mand e refreshing light touch, Neelambari e sleep). Ac-
* Corresponding author. Department of Physiology, M. S. Ramaiah Medical Col- cording to Sama veda and raga chikitsa (Ancient Indian music
lege and group of Hospitals, MSR Nagar, MSRIT Post, Bangalore, Karnataka 560054, literature), ragas that normalize BP are Ahir bhairav, Bhupali, Puriya,
India. Todi, Kausi Kanada, Hindol and Bhimpalas [14,15]
E-mail address: [email protected] (K.U. Kunikullaya).

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Please cite this article in press as: Kunikullaya KU, et al., Combination of music with lifestyle modification versus lifestyle modification alone on
blood pressure reduction e A randomized controlled trial, Complementary Therapies in Clinical Practice (2015), http://dx.doi.org/10.1016/
j.ctcp.2015.05.004
2 K.U. Kunikullaya et al. / Complementary Therapies in Clinical Practice xxx (2015) 1e8

The objective of the present study was to evaluate the change in (GHQ12) [16], involvement in physical activity, diet history, family
stress levels, 24 h ABP and biomarkers of hypertension after 3 history, smoking, alcohol intake history and drug history and a
months of music intervention (using raga Bhimpalas) combined short questionnaire that included questions related to music
with lifestyle modifications, in subjects with prehypertension or preference such as type of instrument, genre, and frequency of
stage I hypertension, in comparison with conventional lifestyle listening and formal training, if any. Standard questionnaires were
modifications. The hypothesis was that there would be a decrease used in this study. The research assistant was trained for 6 months
in 24 h ABP in subjects exposed to music and a concomitant change prior to collection of data. Biostatistician analyzed this data
in the level of stress and biomarkers. collected after 6 months and assured uniformity in sample
collection.
2. Methods
2.5. Experimental outcome measures (at the beginning and at the
2.1. Inclusion and exclusion criteria end of 3 months)

Subjects were recruited by the first author from the out-patient The primary end point of this study was change in 24 h ABP at
department patients and staff of a tertiary care centre. Inclusion the end of intervention. Secondary end points were change in stress
criteria were as follows: Age group between 30 and 60 years; levels (State Trait Anxiety Inventory (STAI)), biomarkers and cor-
prehypertensives and stage I hypertensives as per JNC VII classifi- relation of this with change in BP.
cation [2]. Pregnant women, subjects with body mass index (BMI) Stress levels were assessed using STAI. It is a standardized tool
35 kg/m2, stage 2 hypertension, renal impairment, uncontrolled with forty questions, with four possible responses to each [17,18].
diabetes, stroke, epilepsy, hearing problems, psychiatric disorder, On reliability generalization testing the measures of STAI demon-
other cardiovascular and respiratory disorders were excluded. strated excellent internal consistency (average as>0.89), and
The study period ranged from May 2012 to August 2013. The excellent testeretest reliability (average r ¼ 0.88) at multiple time
study protocol was approved by the institutional scientific com- intervals [19]. The reliability of STAI in patients with anxiety dis-
mittee on human research and ethical review board. order is found to be between 0.87 and 0.93 [20]. The BP (clinical
sphygmomanometry), anthropometric measurements, BMI and
2.2. Sample size waist hip ratio (WHR) were recorded according to standard pro-
tocol [21].
The sample size was calculated (using nMaster 2.0 sample size Those subjects satisfying our inclusion criteria (prehypertensive
software, Department of Biostatistics, CMC, Vellore) based on liter- or stage I hypertensives) were now subjected to 24 h ABP recording
ature survey [7] which indicated that before lifestyle modifications using Schiller BR 102 Plus 24/48 h ABP monitor (ABPM), Schiller
the mean SBP was 133.03 ± 4.4 mm Hg. To calculate sample size, a India. The device was programmed to measure half hourly BP be-
SBP of 133.03 ± 4.4 mm Hg was predicted to reduce after lifestyle tween 07:00 to 22:00 h and hourly BP between 22:00 to 07:00 h.
modification to 130 ± 8 mm Hg; and the group undergoing both Subjects who had 18 readings (out of 39) were included for final
lifestyle modifications and music intervention the SBP was predicted analysis. The values of 24 h overall (average 24 h BP), awake and
to reduce to 126 ± 8 mm Hg; expecting a decrease of 4 mm Hg due to asleep SBP and DBP were recorded. This device has been stan-
music intervention. Using, independent t-test and considering a dardized and validated by British Hypertension Society (BHS) and
mean difference of SBP as 4 mm Hg (SD ¼ 8) with 90% power and 5% Association for the Advancement of Medical Instrumentation
level of significance the estimated sample size was 50 per group. A (AAMI) [22,23].
total of 100 prehypertensives and hypertensives were studied. Five mL of whole venous blood was collected under aseptic
conditions between 09:00 to 10:00 h to avoid diurnal variations.
2.3. Randomization Plasma was separated and stored at 70  C until further analysis.
Plasma catecholamines were measured using CAT Enzyme linked
This was a prospective, open labelled, parallel group, random- immunosorbant assay (DLD Diagnostica GMBH, Germany) within
ized controlled study. The study protocol was explained and one week of its collection. The intra-assay precision as measured by
informed consent was obtained. The subjects were informed about coefficient of variance (CV) was 8.35%, 9.7% and 9.6% for adrenaline,
their rights to withdraw their participation from the study. The noradrenaline and dopamine respectively. Plasma Renin Activity
study's biostatistician randomly placed subjects in the control or (PRA) was determined via radioimmunoassay (Immunotech, Czech
treatment group in 1:1 ratio, by permuting the total sample size Republic). The inter-assay CV was <10.5%.
into 2 arms; the first 50 numbers were allotted to the music
intervention combined with lifestyle modifications (group 1) by 2.6. Intervention
tossing the coin and the next 50 into the other group (for only
lifestyle modifications e group 2). No stratification for age, sex, or 2.6.1. Lifestyle modification (as per JNC VII) [2].
BP range was performed. The random number indicating inter- Counselling for lifestyle modifications and various non-
vention or control was kept in an opaque and sealed envelope and pharmacological measures was given to all the subjects as per
the serial number of the patients were written on the top of the JNC VII guidelines. Handouts were given to enhance compliance
envelope. The envelope was opened by the research assistant after and to help them recall the instructions.
the baseline assessment of each participant had been completed
and assigned the participants to both the arms. All the other in- 2.6.2. Music intervention
vestigators who did the outcome assessments were blinded to the Music was provided to the subjects based on their personal
interventions. preference (compact discs, mobiles, i-pods). A 22 min instrumental
(Bansuri) music, playing raga Bhimpalas without any accompani-
2.4. Baseline characteristics ments was used. According to study protocol, the subjects had to
listen to this music for about 15 min daily (during the same time
Detailed baseline characteristics recorded on a pretested, semi- every day, preferably without interruptions) at least 5 days a week
structured proforma, included general health questionnaire for 3 months, irrespective of the music which they listen to

Please cite this article in press as: Kunikullaya KU, et al., Combination of music with lifestyle modification versus lifestyle modification alone on
blood pressure reduction e A randomized controlled trial, Complementary Therapies in Clinical Practice (2015), http://dx.doi.org/10.1016/
j.ctcp.2015.05.004
 K.U. Kunikullaya et al. / Complementary Therapies in Clinical Practice xxx (2015) 1e8 3

otherwise. The music intervention group also followed lifestyle Student t test/Wilcoxon signed rank test. Qualitative data was
modifications. expressed as percentages. Chi square and Fischer's test was applied
to test for associations between the categorical variables. Pearson's
2.7. Follow up correlation coefficient was used to estimate the correlation be-
tween BP and biomarkers. Significant predictors in the univariate
Weekly follow up was done to ensure compliance towards the analysis were then included in a forward stepwise multiple logistic
intervention (by personal contact) (Fig. 1). Any change in pharma- regression model to assess the independent predictors of change in
cological management was periodically monitored and recorded. BP. In order to study interaction effect, repeated measures ANOVA
was used. P value of 0.05 was considered as the level of signifi-
2.8. Statistical analysis cance. The data was analyzed using SPSS software Version 18.0
(SPSS Inc., Chicago, USA).
Quantitative data were expressed as mean, standard deviation
(SD), median and inter-quartile ranges. Differences in the mean/ 3. Results
median values between groups were tested by student t test/non-
parametric tests of significance (Mann Whitney U test). Mean dif- A total of 50 subjects were recruited in both the groups namely,
ferences between pre and post intervention was assessed by paired music along with lifestyle modifications (group 1) and only lifestyle

Fig. 1. Consort diagram of participant recruitment, distribution and follow up.

Please cite this article in press as: Kunikullaya KU, et al., Combination of music with lifestyle modification versus lifestyle modification alone on
blood pressure reduction e A randomized controlled trial, Complementary Therapies in Clinical Practice (2015), http://dx.doi.org/10.1016/
j.ctcp.2015.05.004
4 K.U. Kunikullaya et al. / Complementary Therapies in Clinical Practice xxx (2015) 1e8

modification (group 2). Most of the subjects reported that they the DBP decreased significantly in group 1 (P ¼ 0.05), but not in
were following the lifestyle modifications recommended and that group 2 (P ¼ 0.097). Rest of the BP measurements did not vary
they were also listening to music as per instructions. A few subjects significantly. Further, on exclusion of diabetics it was found that the
were lost due to various reasons during follow up. ABPM of twelve decrease in DBP (overall, P ¼ 0.006 and awake, P ¼ 0.021) persisted
subjects could not be recorded (5-refused to wear, 7-due to non- in group 1 and the reduction in SBP remained in group 2 (overall,
availability). Blood sample was not drawn from 11 subjects (9- P ¼ 0.030, awake, P ¼ 0.043) and was statistically significant.
due to non-availability, 2-refused to give blood). Questionnaire
recording was incomplete due to non-availability of 4 subjects. The
3.4. Factors affecting the change in DBP in multiple logistic
final analysis was done on 49 subjects in group 1 and 47 in group 2.
regression analysis
3.1. Baseline characteristics
All parameters that significantly changed after intervention on
univariate analysis (Supplementary file e list of covariates) were
Mean age, gender, BMI and WHR were comparable between the
further analyzed using multiple logistic regression analysis to
two groups. Twelve and 14% of the subjects were smokers and 22
confirm their effects on the post intervention overall DBP (overall
and 32% were current alcoholics in group 1 and group 2 respec-
DBP significantly declined in group 1 which was our main experi-
tively. History of smoking and consumption of alcohol did not differ
mental group) in both the groups. The subjects were categorized
significantly throughout the study in both the groups (Table 1).
into 2 groups based on change in overall DBP into those with <2
Other data in Supplementary file.
and > 2 mm Hg change after intervention (The association of the
co-variates were studied with the dichotomized DBP levels). Post-
3.2. Blood pressure measured by ABPM
intervention STAI state score was the only variable which showed
association with the change in DBP in group 1 (Odds ratio 0.156;
3.2.1. Baseline ABPM
95% CI ¼ 0.03e0.84; P ¼ 0.03). Those subjects who had lesser STAI
The number of subjects in the prehypertension range (JNC VII
state score after intervention (92.6%) showed a higher fall in DBP
Criteria) was higher in both the groups (Table 1) [2]. Prior to
(>2 mm Hg) in group 1(P ¼ 0.02) (Chi-square analysis). In group 2
intervention none of the BP measures were statistically different
only BMI had a significant association with the DBP (Odds ratio
between the two groups (Table 2).
0.045; 95% CI ¼ 0.003e0.61; P ¼ 0.02). Those with BMI in normal
range and pre-obese range had higher fall in DBP (P ¼ 0.02)
3.3. Pre versus post intervention ABPM
(Table 3). On combining both the groups, the only factor that had a
significant association was BMI (Normal BMI e P ¼ 0.01, Preobese
The SBP decreased by 1.3 (overall) and 1.7 (awake) mm Hg in
BMI e P e 0.042).
group 1, but this was not statistically significant. However, a sta-
tistically significant reduction in SBP was found in group 2 (overall
e 3.2 mm Hg, P ¼ 0.015 and awake e 3.7 mm Hg, P ¼ 0.026). 3.5. Stress (STAI)
Diastolic BP decreased significantly in group 1 (overall e 2.1 mm
Hg, P ¼ 0.004 and awake DBP e 1.83 mm Hg, P ¼ 0.021). In group 2, Prior to intervention the stress levels among both the groups
the overall DBP decreased significantly (P ¼ 0.015) (Table 2). was comparable. It decreased significantly after intervention in
On analysis of the data after excluding smokers and alcoholics both the groups (P  0.001) (Tables 1 and 4).

Table 1
Comparison of baseline characteristics between the groups presented as mean (SD) and percentage.

Variable Groups for analysis Group 1 (N ¼ 50) Group 2 (N ¼ 50) P

Age (Years) as mean(SD) 46.50(8.5) 46.88(8.5) 0.824

BMI (kg/m2) as mean(SD) 25.93(3.9) 25.86(3.1) 0.925
WHR 0.92 0.94 0.147
GHQ12 Score as mean(SD) 11.74(3.1) 12.72(2.9) 0.106
Males 60 74 0.137
Based on SBP (On the basis of Clinical BP measurement) Pre hypertensive 86 72 0.086
Stage I Hypertensive 14 28
Hypertension present (Based on history) 46 34 0.221
Age at diagnosis as mean(SD) Years 44.87(6.7) 44.12(7.5) 0.741
Non pharmacological measures followed to control hypertension Diet modification 2 4 0.608
Walking 4 8
Exercise 2 2
Yoga 2 0
Meditation 6 0
Medication b blockers 10 4 NC
ACE inhibitors 0 2
Calcium channel blockers 4 4
b blockers þ Calcium channel blockers 4 4
Angiotensin receptor blockers 16 6
Ayurvedic medicine 0 2
STAI state score <40 86 84 0.078
40 14 16
STAI trait score <40 68 68 <0.001
40 32 32
STAI state score as mean(SD) 31.34(10.3) 34.76(8.4) 0.072
STAI trait score as mean(SD) 36.82(8.7) 38.3(8.4) 0.389

Note: N ¼ sample size in each group, NC¼Not computed, STAI¼State Trait Anxiety Inventory, SD¼Standard Deviation; P < 0.05 was considered significant.

Please cite this article in press as: Kunikullaya KU, et al., Combination of music with lifestyle modification versus lifestyle modification alone on
blood pressure reduction e A randomized controlled trial, Complementary Therapies in Clinical Practice (2015), http://dx.doi.org/10.1016/
j.ctcp.2015.05.004
 K.U. Kunikullaya et al. / Complementary Therapies in Clinical Practice xxx (2015) 1e8 5

Table 2
Comparative data of pre versus post intervention 24 h ABPM within group 1 and 2.

Group Pressure INT SBP (mm Hg) DBP (mm Hg)

Mean(SD) 95% CI P Mean(SD) 95% CI P

Group 1 Overall Pre 130.74(8.7) 124.8e137 0.261 85.1(6.8) 81e87.3 0.004

(n ¼ 45) Post 130.02(12.2) 121e135.5 83(8.7) 77e89
Awake Pre 133.34(9.1) 125.8e140.3 0.216 87.72(7.6) 83e91 0.021
Post 132.18(12.9) 121.5e139.5 85.89(9.2) 78.5e92.5
Asleep Pre 122.7(11.5) 115e126.5 0.506 76.4(6.8) 71.8e80.3 0.285
Post 124.58(15.5) 113.5e132.5 75.6(10.3) 68.5e80
Group 2 Overall Pre 133.12(11.8) 122.8e141.3 0.015 85.24(7.3) 79.5e92 0.015
(n ¼ 43) POST 129.91(11.5) 122e136 82.58(8.0) 76e88
Awake Pre 136.36(11.9) 127e145.3 0.026 88.16(7.5) 82e94 0.084
Post 132.53(11.5) 125e139 86.02(7.8) 79e91
Asleep Pre 122.32(16.3) 109.8e132 0.483 75.42(10.9) 67e80.3 0.324
Post 121.16(13.1) 112e130 74.14(8.4) 68e78

Paired t test was employed to compare pre and post values within a group; Unit of BP is in mmHg; Values are given as mean (SD), P Value of <0.05 is considered significant.

Table 3
Multiple forward stepwise logistic regression analysis between change in DBP and factors which showed significant relation on (STAI state score and BMI) in both the groups.

Group Change in DBP (mm Hg) STAI state score c2 P BMI categories (kg/m2) c2 P

<26 >26 18.5e24.99 25e29.99 >30

1 <2 65.2 34.8 5.82 0.016 39.1 52.2 8.7 4.11 0.122
>2 92.6 7.4 51.9 25.9 22.2
2 <2 61.9 38.1 0.512 0.474 42.9 57.1 0 5.8 0.022
>2 51.7 48.3 51.7 31 17.2

Total number of subjects was 50 in each group (100%); List of covariates that showed significant difference on univariate analysis is shown in appendix; P value of >0.05 was
considered significant.

3.6. Biomarkers of hypertension intervention in group 1; but this significance was not observed after
log conversion for noradrenaline and PRA (Table 4). It was hy-
There was a statistically significant decrease in PRA (P ¼ 0.046), pothesized that the anticipated reduction in BP is likely to correlate
noradrenaline (P ¼ 0.049) and dopamine (P ¼ 0.002) levels after with the levels of biomarkers. On analysis within the group a sig-
nificant negative correlation between the post intervention overall
Table 4 and awake DBP with adrenaline (P < 0.05) was found. However
Comparison of pre versus post intervention stress scores and biomarkers of hy- only 16% (r2) of the effect on overall DBP was explained by adren-
pertension within group 1 and group 2. aline values. None of the other biomarkers were correlating with
Group STAI Scores Pre (n ¼ 49) Post (n ¼ 47) Pre vs post the DBP.
Mean(SD) Mean(SD) P

1 State 31.34(10.3) 27.69(6.1) 0.001 3.7. Subgroup analysis

Trait 36.82(8.7) 30.9(5.3) <0.001
PRE (N ¼ 50) Post (N ¼ 47)
See supplementary file.
2 State 34.76(8.4) 30.53(5.5) <0.001
Trait 38.3(8.4) 33.77(5.8) <0.001
1 Adrenaline PRE (n ¼ 46) POST (n ¼ 43) 4. Discussion
pg/mL 40.13(27.3) 40.29(19.8) 0.595
Log10 1.5(0.3) 1.55(0.2) 0.219
Noradrenaline
In this study role of Indian music on BP was evaluated among
pg/mL 467.87(294.9) 400.43(186.9) 0.049 prehypertensives and stage I hypertensives. We choose a particular
Log10 2.51(0.5) 2.54(0.3) 0.376 raga after referring to ancient literature in music according to
Dopamine which a few ragas of Indian music could normalize BP. According to
pg/mL 59.07(43.9) 40.43(38.4) 0.002
Swara shastra, there are 72 parent ragas (melakartha ragas) which
Log10 1.62(0.4) 1.45(0.4) 0.001
PRA transmit life energy through nadis [15] (energy channels e Ayur-
ng/mL/hr 3.05(2.4) 2.67(2.4) 0.046 vedic concept) according to its lakshana (norms) and pitch. Sama
Log10 0.34(0.4) 0.31(0.3) 0.11 Veda, music therapy and Raga chikitsa have identified specific ragas
2 Adrenaline and their benefits. Raga Bhimpalas was chosen among all the ragas
pg/mL 43.2(25.7) 38.76(21.6) 0.349
Log10 1.54(0.3) 1.5(0.3) 0.558
that normalize BP [14,15]. This raga is predominantly made of komal
Noradrenaline (soft) notes. Komal notes always create a positive impact on the
pg/mL 440.93(310.9) 434.26(246.1) 0.564 mind with parasympathetic dominance, irrespective of the musical
Log10 2.49(0.4) 2.56(0.3) 0.811 training of the person [24].
Dopamine
Instrumental music was used because it uses musical compo-
pg/mL 50.8(27.9) 49.92(68.6) 0.124
Log10 1.62(0.3) 1.49(0.4) 0.073 nents like pitch, intensity, and timbre and it does not contain lyrics.
PRA So, the effect generated is exclusively by the musical components.
ng/mL/hr 1.75(1.9) 2.46(1.7) 0.012 Very little literature available on the most relaxing or soothing
Log10 0.06(0.4) 0.3(0.3) 0.002 instrument, we chose bansuri/flute for this study. Flute is one of the
P Value of <0.05 is considered significant; PRA, plasma renin activity. most common instruments used in musical pieces meant for

Please cite this article in press as: Kunikullaya KU, et al., Combination of music with lifestyle modification versus lifestyle modification alone on
blood pressure reduction e A randomized controlled trial, Complementary Therapies in Clinical Practice (2015), http://dx.doi.org/10.1016/
j.ctcp.2015.05.004
6 K.U. Kunikullaya et al. / Complementary Therapies in Clinical Practice xxx (2015) 1e8

relaxation or meditation in India. The use of percussion in- modifications in order to avoid intervention bias for the second
struments was avoided as tempo has been shown to significantly group of subjects. Music based intervention to study change in BP
affect the heart in various ways [25]. have not used ABPM [6e8].
Stress decreased after intervention significantly in both the
groups. Classical music is an effective stress buster and stress 4.2. Study limitations
reduction can effectively reduce BP [26,27]. In this study subjects
were educated about the ill effects of stress on health and emphasis Acute effect of music on BP, stress and biomarkers of hyper-
was laid on the various methods of stress reduction. tension was not studied. A better effect on BP could have been
In group 1, there was a significant decrease in overall and awake observed if we had used familiar rather than unfamiliar music
DBP (~2.5 mm Hg) after intervention. Previous studies have re- intervention. However, music preference is purely subjective and
ported reduction in SBP by > 10 mm Hg and DBP by > 4 mm Hg varies widely among individuals. Music intervention combined
after 2e3 months of music intervention [4e8]. These studies used with slow breathing may be a better intervention. Better compli-
one time sphygmomanometric BP monitoring. The magnitude of ance can be achieved in a laboratory. The study was conducted on a
reduction in SBP and DBP was lesser in the present study. This can non-homogenous sample (prehypertensives and hypertensives in
be attributed to 24 h ABP monitoring which is more accurate since the same group; on or off treatment).
it takes multiple measurements (>18/day) and averages them.
Home BP and ABP measurements are lower than those obtained by 5. Conclusion
clinic measurements [28].
After lifestyle modification (predominantly change in diet and Music when used as an adjunct benefitted subjects with initial
stress; Supplementary file) in group 2, there was a statistically BP in prehypertension range. NPM for reduction of stress should be
significant decrease in overall, awake SBP and overall DBP. included in the recommendations given by JNC VII for better con-
Subjects who had lesser post intervention state anxiety score trol of BP.
had a higher fall in DBP (logistic regression) [29]. A significant
negative correlation has been observed between the trait score Authors' contributions
and flow mediated dilation [30]. In group 2 and on combining
both the groups, subjects with BMI in normal and pre-obese UKK, GJ, VJ, DV, VSP and NSM were responsible for the study
range had higher fall in DBP [31]. Thus, it is important to be conception and design. UKK, GJ, VJ and PAH performed the data
less anxious and maintain an optimal BMI for effective control of collection and intervention. UKK, RK and NSM performed the sta-
BP. tistical analysis and interpretation of data. UKK, GJ and NSM were
Subgroup analysis (Supplementary file) showed that subjects responsible for drafting and editing the manuscript. All authors
with pre-intervention SBP in prehypertension range, overall DBP reviewed, edited and approved the final manuscript.
decreased by 3.18 mm Hg after intervention in group 1 and
2.54 mm Hg in group 2. Lifestyle modifications aided in reducing Source of Funding
overall and asleep SBP significantly among stage I hypertensives in
group 2. Group 1 subjects with DBP in prehypertension range prior This research was supported by Indian Council for Medical
to intervention, had a statistically significant decline after inter- Research, Government of India (ICMR Project number: 2010-
vention, with fall in overall SBP (3.78 mm Hg), DBP (4.93 mm Hg); 13440). Clinical Trials.gov Identifier: NCT02147366; Full trial pro-
awake SBP (4.11 mm Hg), DBP (4.56 mm Hg) and asleep DBP tocol can be accessed from clinicaltrials.gov.
(3.59 mm Hg). Group 1 had 86% of subjects in prehypertension
range prior to intervention (with or without medication). Listening Conflict of interest
to music produced a significant reduction in BP among these sub-
jects specifically. This proves that music can be a useful adjunct in None.
normalizing the BP. Implementation of only lifestyle modifications
did not completely normalize the BP in prehypertensives of group Acknowledgments
2.
The plasma catecholamines and PRA decreased after music We acknowledge Vidhwan Pravin Godhkhindi, an exponent
intervention, similar to previous reports [32]. The possible absence flautist, who exclusively recorded the musical piece for us. We
of the correlation between biomarkers with the change in DBP acknowledge management of M S Ramaiah group of institutions
could be due to an attempt to establish correlation of biomarkers and all the subjects who participated in this study.
with 24 h BP levels. Instead, BP measured at the time of drawing
blood might have given better correlation on analysis. However, Appendix A. Supplementary data
monitoring these subjects for a longer period of time might have
decreased these biomarkers significantly along with BP, as BP Supplementary data related to this article can be found at http://
decrease follows the long term decrease in the causative factors. dx.doi.org/10.1016/j.ctcp.2015.05.004.

References
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Please cite this article in press as: Kunikullaya KU, et al., Combination of music with lifestyle modification versus lifestyle modification alone on
blood pressure reduction e A randomized controlled trial, Complementary Therapies in Clinical Practice (2015), http://dx.doi.org/10.1016/
j.ctcp.2015.05.004
 K.U. Kunikullaya et al. / Complementary Therapies in Clinical Practice xxx (2015) 1e8 7

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way noise stress in mice. Noise Health 2013;15:217e23. dicting Breast Cancer Survival Outcome.

Please cite this article in press as: Kunikullaya KU, et al., Combination of music with lifestyle modification versus lifestyle modification alone on
blood pressure reduction e A randomized controlled trial, Complementary Therapies in Clinical Practice (2015), http://dx.doi.org/10.1016/
j.ctcp.2015.05.004
8 K.U. Kunikullaya et al. / Complementary Therapies in Clinical Practice xxx (2015) 1e8

Dr. Venkatesh D., MD, employed as senior professor of arrhythmias and elective Coronary Angioplasties as Primary Operator and over 1600
Physiology, M.S. Ramaiah Medical College, MSRIT Post, primary PTCAs.
Bangalore e560 054. He has authored books such as asics
of Anatomy, Physiology and Microbiology for GNM stu-
dents, Basics of Medical Physiology (Level 2) for Nursing
students, Basics of Medical Physiology (Level 3) for Dental Professor Murthy N.S., is one of the well-known bio-
and Physiotherapy and is the section Editor for 13th Edi- Statistician, did his Ph.D. (Epidemiology), School of Public
tion of Best and Taylor's Physiological basis of Medical Health, University of Tampere, Finland, 1996. He is
Practice. He is a recipient of Prof. Puthuraya National Best currently employed as Research Director, Division of
Teacher award for the year 2011 by Association of Physi- Research & Patents, Gokula Education Foundation (Medi-
ologists and Pharmacologists of India, presented at Annual cal), Professor &Research Coordinator, Department of
National Conference of association, at AIIMS, New Delhi Community Medicine, M.S. Ramaiah Medical College,
during December 2011. He has been completed two year Bangalore, 560054. He super-annuated from the services
International fellowship awarded by Foundation for during the year 2004 from the Institute of Cytology &
Advancement of International Medical Education and Research (FAIMER) in the year Preventive Oncology, Indian Council of Medical Research
2007 at Philadelphia, USA for Innovation in Medical Education. His research interests (ICMR), New-Delhi as Sr. Grade Deputy Director (Bio-Sta-
include Stress and coping techniques, Medical Education. He is a member of the tistics) and later on, continued his research and teaching
editorial board of various journals such as Indian journal of Physiology and Pharma- activity as Emeritus Medical Scientist under ICMR at the
cology, Indian journal of Experimental Biology, Journal of Natural Remedies, Biomed- Institute of Pathology, New Delhi/National Cancer Registry
icine, National journal of Basic Medical Sciences, Al Ameen Journal of Medical Sciences, Programme (ICMR), Bangalore. He is emeritus scientist of ICMR (Cancer research di-
International Journal of Physiology. vision).
His main area of interest includes teaching of Bio-statistics, Research methodology,
designing, execution and analysis of data of epidemiological research studies in the
Dr. Prakash V.S. has completed DM (Cardiology), Cardiac field of bio-medical sciences, public health, dental health and cancer epidemiological
Clinical Electrophysiology Fellowship (Taiwan). He is studies. He has received special training in MRC Biostatistics unit, Institute of public
presently the Professor & Head of the department of car- health, Cambridge, UK, 1997; Institute of Public Health, Finnish Society of Bio-Statistics,
diology. Helsinki, Finland, 1994; Population Centre for University of Pennsylvania and depart-
He was the first in India to perform catheter based ment of Sociology, University of Helsinki, Finland, 1994; International Course on Cancer
ablation for atrial fibrillation in 1999. He has performed Epidemiology, National Institute of Occupational Health, Ahmedabad, 1992; INDO_US
over 350 cases of PV isolation (LACA)- for paroxysmal workshop on Ophthalmology, held at ICMR, New Delhi , 1990. He is a recipient of
atrial fibrillation, 155 cases of LACA+ LA roof line/endo- Achanta Lakshmi Patti Oration Award, 2013-14, National Academy of Medical Sciences,
cardial CS isolation and lateral mitral isthmus line for New Delhi; Docent in Epidemiology, University of Tamper, Finland, 2008; Fellow of
persistent/chronic atrial fibrillation. He has performed Society for Medical Statistics (India), 2006 (FSMS); Fellow of Academy of Medical
ablations for complex arrhythmias such as atrial tachy- Sciences (India), 2005 (FAMS); L.B. Mahajan award (1976); Prof. B.G. Prasad Award
cardia in post mitral valve replacement, percutaneous (1990 and 1995); Tampere University Research Fellowship awarded by the Govt. of
epicardial mapping and ablation for complex ventricular Finland for undergoing Post Graduate training and Doctoral Degree in Epidemiology at
tachycardia using 3D electro anatomical mapping the Dept. of Public Health , Finland during the year 1993-94, 1996; ICRETT Fellowship
(CARTO); Permanent pacemaker implantation: Over 1500 VVI, 1050 Dual Chamber and (UICC, WHO, 1997); Two of the five most cited papers of ICMR research papers in the
5 biatrial pacing as single operator; ICD and Heart failure device implantation: 175 domain of Cancer research between 1950-2010 has been co-authored by Dr N S
ICDs and 180 biventricular pacing; performed over 3500 ablations for various Murthy as per the citation classics of ICMR research papers.

Please cite this article in press as: Kunikullaya KU, et al., Combination of music with lifestyle modification versus lifestyle modification alone on
blood pressure reduction e A randomized controlled trial, Complementary Therapies in Clinical Practice (2015), http://dx.doi.org/10.1016/
j.ctcp.2015.05.004