Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03790462 |
| Other study ID # |
2017-0174 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2019 |
| Est. completion date |
February 9, 2021 |
Study information
| Verified date |
February 2021 |
| Source |
MS Ramaiah Medical College & Hospitals |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In India, music is predominantly used as entertainment. Despite ample vedic literature
available on the beneficial effects of ragas in Indian music on human mind and body,
scientific evidence for the same is extremely meager. This initial systematic study of 6
ragas, is an attempt to provide scientific evidence and validate the use of Indian classical
music & thus present the scientific community with a new complementary therapy / non-
pharmacological mode of treatment which could be used in prevention of various
non-communicable diseases. In our previous study on prehypertensives and hypertensives, blood
pressure (BP) reduced significantly after listening to Indian music [raga 'bhimpalas' (raga
that normalizes BP)], daily for 3 months. Heart rate variability (HRV) recorded once on
recruitment and end of study failed to show any change. On retrospection, we realised that
the effect of only a single raga had been tested and the acute effects had not been
elucidated. Specifically, EEG waves & cognitive ERPs were not studied. Hence a study
encompassing all the 6 ragas that are known to normalize BP as given in literatures such as
Gandharva Veda (Sama Veda) & Raga Chikitsa was planned. Among these, 3 ragas are now being
studied & data analysis is in line. This proposal is to study the immediate
electrophysiological changes with remaining 3 ragas. Music can be prescribed as a cheap and
effective adjuvant in the treatment of hypertension along with other lifestyle modifications.
To the best of our knowledge, there is scanty literature testing Indian ragas. Thus there is
a great need to address this issue.
Description:
INDIAN MUSIC: 'Raga' (musical scale) is a set of musical notes presented in an orderly manner
in order to generate a melody out of the same. Matanga (9-10th century AD) in his work
'Brihaddeshi' was the earliest to define raga as "raga is that kind of sound composition
consisting of melodic movements which has the effect of colouring the hearts of men".
However, there have been very few studies which have used Indian classical music as an
intervention for studying their health benefits. Gandharvaveda, a part of Sama veda, has
mentioned various ragas to have myriad health benefits.Dr. Burnell has mentioned a manuscript
named raga chikistsa in the collections of Saraswati Mahal Library in Tanjore which deals
with the various ragas that can be used for curing various ailments. For example raga
Malkauns is said to help in curing hypotension. Insomnic patients are said to benefit by
usage of raga Behag. 'Heart Rate Variability' has become the conventionally accepted term to
describe beat-to-beat alteration in HR, and RR intervals in ECG. The cause of HRV is
considered to be respiratory sinus arrhythmia as well as low-frequency oscillations (0.1 Hz)
associated with Traube-Hering-Mayer waves of BP . It was found that a decrease in HRV was a
strong predictor of mortality after acute myocardial infarction . HRV is assessed by either
time or frequency domain methods. EFFECT OF MUSIC ON BLOOD PRESSURE:Many studies have shown
that there is a modification of cardiorespiratory parameters on repeated rhythymic recitation
of a prayer, poetry or yoga mantra . So it is not surprising that music (rhythmic repetition
of notes and tones) can also have similar effects. A number of studies have reported that
listening to sedative music (slow tempo, legato phrasing, and minimal dynamic contrasts) can
lead to decreased HR and BP. BP was shown to be proportional to the crescendo present in
music, where as music with uniform emphasis reduced the BP .
Passive listening to music on a daily basis helped in reducing BP of 12 elderly subjects. The
experimental group listened to selected songs for 25 minutes every day, for four weeks. BP
was measured twice a week. There was a significant decrease in the mean BP: 11.8 mmHg in the
SBP and 4.7 mmHg in the DBP . Elderly subjects have shown statistically significant reduction
in SBP and DBP after 12-minute audio relaxation program . STUDIES ON EFFECT OF MUSIC ON HRV:
Whether music causes an increase or decrease in HR, remains a mystery . Several studies
reported that under various conditions music decreases sympathetic nervous system (SNS) and
increases parasympathetic nervous system (PNS) activity as measured by HR and HRV, indicating
physiological relaxation . No difference in HR or HRV was observed by a few investigators .
However, an increase in HR has also been reported by some . SALIVARY STRESS MARKERS: The
salivary glands receive sympathetic and parasympathetic innervations. The major enzyme that
is released on sympathetic stimulation is alpha (α) amylase. Thus it is presumed that,
changes in salivary alpha amylase indicate the activity of the SM system during stress.
Further, both salivary cortisol and alpha amylase have been used by number of researchers
recently to quantify stress or as biomarkers of stress. Nevertheless, it has also been put
forth that salivary amylase activity is an index of plasma norepinephrine levels under a
variety of stressful conditions. STUDIES ON EFFECT OF MUSIC ON EEG: In one study where EEG
was recorded after giving alpha music to about ten subjects, it was observed that increase in
the maximum amplitudes of Alpha waves either after 6 minutes or after 12 minutes of alpha
music. However, the maximum amplitude of beta waves showed a decline of up to 40% from the
initial value. These results, namely, the increase in Alpha activity and decrease in Beta
activity indicate that subjects experience 'relaxed alertness'.
Setting: Medical college and Tertiary care hospital Case group (totally 3 groups) = 35
subjects in each group; a total sample of 105 Control group = 35 subjects Basis for sample
size:Based on the study conducted by Okada et al, it was found that RMSSD (root mean square
standard deviation of NN intervals on ECG) was 17.4±7.2 ms and 24.1±15.5 ms before and after
music therapy with an effect size of 0.59 and power of 90% and confidence interval of 95%,
the minimum sample size required for the present study was estimated to be 32.
Methods and materials: The effect of at least 3 different Indian classical music ragas on the
autonomic functions and brain waves of subjects will be studied. Healthy subjects will be
recruited from M S Ramaiah Instituitions. Selection bias will be avoided by randomization
using computer generated random numbers. All numbers generated will be kept in an opaque and
sealed envelope. The envelope will be opened by the research assistant after the baseline
assessment of each participant and assigned to each of the seven groups randomly, into all
intervention and control categories. Each group will randomly be assigned to listen to a
particular raga using block randomization. The control group, the seventh group, will not
receive any raga, but HRV,BP, EEG and saliva will be recorded and collected. Literature given
in Gandharva veda and raga chikitsa will be used to choose ragas which have varied health
benefits especially on the cardiovascular system. The ragas which have been said to normalize
the BP are ahir bhairav, bhimpalas, hindol, puriya, kausikanada and todi. Ahir Bhairav, Kausi
Kanada & Bhimpalas will be used for the present study. Detailed methodology: The
investigators will include a few questions inquiring the subjects' preference of type of
music, previous experience with music instrumental or vocal training and note the same. A
general health check up will be done for all subjects. The BMI, waist hip ratio and BP in
sitting position measured twice after five minutes rest (Sphygmomanometry) in between will be
noted. A stress questionnaire (State Trait Anxiety Inventory) will be administered prior to
and after intervention to assess the baseline level of stress and the change in stress levels
after music intervention.
Subjects will be made to lie supine and relax for ten minutes. EEG electrodes will be applied
according to 10-20 system. A baseline EEG (Galileo NT) and ECG in lead II for 10 minutes
(Power lab 15 T Labchart by AD instruments) will be recorded. Baseline digital measurement of
BP will be done. Saliva for baseline stress markers (cortisol and amylase) will be collected.
All the subjects will be instructed to breathe at a rate of 6 breaths per minute, throughout
the procedure that will be monitored by the software. After this, a raga from Indian
classical music will be played for 10 minutes duration via earplugs connected to the laptop,
during which time the recording of ECG and EEG will continue. The time of start of music will
be marked using an event marker in the software. Post ten minutes, the music will be stopped
and BP will be recorded and saliva will be collected. ECG and EEG recording will continue for
another ten minutes to study any residual effects of music on the heart after which BP will
be recorded and saliva will be collected again (end of 30 minutes procedure). Stress
questionnaire will be administered at the end of the procedure. For those in control group
baseline BP, ECG and EEG will be recorded for ten minutes under resting conditions. Saliva
will be collected and stored. EEG will be analyzed using Galileo NT software. HRV will be
analyzed using the software provided. The saliva samples will be centrifuged at 3000 rpm for
15 minutes and supernatant saliva stored at -20° C until further analysis for cortisol and
amylase (ELISA).
