Indian Ragas on Health - a Electrophysiological Study (RAGA-1)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Blood pressure (BP) reduced significantly after listening to Indian music among
      prehypertensives and hypertensives in all subjects who were given a musical piece composed on
      raga 'bhimpalas' (raga that normalizes BP) to be heard daily for 3 months. On retrospection
      into the methodology, the effect of a single raga (Bhimpalas) alone had been tested. Heart
      rate variability (HRV) recorded once on recruitment and followed up after 3 months failed to
      show any change. The acute effect of music on HRV while listening to raga bhimpalas, and the
      effect of all ragas listed in Gandharva veda had not been tested. Respiratory rate was not
      controlled (affects HRV) and EEG waves were not studied.
    

Detailed 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).
    

Intervention name(s): Music Intervention
Intervention type(s): Other
Intervention description(s): A raga will be played for 10 minutes & data collected.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care