Select Indian Ragas on Electrophysiological Parameters

NCT03790462 | Completed DMC

• 1 other identifier: 2017-0174
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychology, Social; Stress; Stress, Psychological

Keywords

Stress, Electroencephalogram,Indian Music, Electrocardiogram

Outcome Measures

Primary Outcomes (4)

• Change in Blood pressure

  in mm Hg

  Baseline, 10 minutes after music intervention & 10 minutes post intervention

• Change in Electroencephalogram amplitude

  Change in Electroencephalogram (EEG) waves amplitude (in mV)

  Baseline, 10 minutes during music intervention & 10 minutes post intervention

• Change in Electroencephalogram Frequency

  Change in Electroencephalogram Frequency (in Hz)

  Baseline, 10 minutes during music intervention & 10 minutes post intervention

• Change in Stress using state trait anxiety inventory

  State trait anxiety inventory score in numbers - It comprises separate self-report scales for measuring two distinct anxiety concepts: state anxiety and trait anxiety. The STAI-T scale consists of 20 statements that ask people to describe how they generally feel. The STAI-S scale also consists of 20 statements. Each question is rated on a 4-point scale (not at all, somewhat, moderately so, very much so). The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-T and STAI-S subscales. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

  Baseline, after 10 minutes of music intervention & 10 minutes post intervention

Secondary Outcomes (3)

• Change in Heart rate variability

  Baseline, 10 minutes during music intervention & 10 minutes post intervention

• Change in Salivary Cortisol

  Baseline, after 10 minutes of music intervention & 10 minutes post intervention

• Change in Salivary alpha amylase

  Baseline, after 10 minutes of music intervention & 10 minutes post intervention

Study Arms (4)

Music intervention group 1

EXPERIMENTAL

Raga "A" will be played for 10 minutes \& data collected.

Other: Music intervention

Music intervention group 2

EXPERIMENTAL

Raga "B" will be played for 10 minutes \& data collected.

Other: Music intervention

Music intervention group 3

EXPERIMENTAL

Raga "C" will be played for 10 minutes \& data collected.

Other: Music intervention

Control group

NO INTERVENTION

Subject relaxes without music for 10 minutes and electrophysiological parameters will be collected

Interventions

Music intervention OTHER

A raga out of 3 select Indian classical ragas "Puriya/Hindol/Todi" will be played for 10 minutes \& data collected.

Music intervention group 1; Music intervention group 2; Music intervention group 3

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects
• Age group of 18-30 years
• Either gender will be included as autonomic functions change with age
• Non smokers
• Non alcoholics.

You may not qualify if:

• Any cardiovascular disorders,
• Renal disorders,
• Respiratory disorders,
• Endocrine disorders,
• Neurological problems
• Pregnancy,
• Body mass index (BMI)\>30 kg/m2,
• Hearing problems,
• Psychiatric disorder
• Drugs which are known to affect the BP or autonomic status of the individual
• Other impairments that prevent the subject from performing few experimental procedures will be excluded.

Sponsors & Collaborators

• MS Ramaiah Medical College & Hospitals: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

M S Ramaiah Medical college and hospitals

Bangalore, Karnataka, 560054, India

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• MEDHA RAO Y, MD

  M S Ramaiah Medical college and hospitals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: It is a triple blinded study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 31, 2018
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: February 9, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)