NCT02691585

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

3 years

First QC Date

January 27, 2016

Last Update Submit

August 13, 2019

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in Blood pressure

    in mm Hg

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

Secondary Outcomes (6)

  • Change in Salivary alpha amylase

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

  • Change in Heart rate variability - time domain

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

  • Change in Heart rate variability - frequency domain

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

  • Change in Electroencephalogram Frequency

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

  • Change in Electroencephalogram wave amplitude

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

  • +1 more secondary outcomes

Study Arms (4)

Music intervention group 1

EXPERIMENTAL

Raga 1 will be given

Other: Music Intervention

Music intervention group 2

EXPERIMENTAL

Raga 2 will be given

Other: Music Intervention

Music intervention group 3

EXPERIMENTAL

Raga 3 will be given

Other: Music Intervention

Control Group 4

NO INTERVENTION

No raga. Just collection of electrophysiological parameters will be done.

Interventions

Music InterventionOTHER

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

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

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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,
  • Stroke,
  • Pregnancy,
  • Body mass index (BMI)\>30 kg/m2,
  • Epilepsy,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M S Ramaiah Medical college and hospitals

Bangalore, Karnataka, 560054, India

Location

Related Publications (1)

  • Kunikullaya KU, Goturu J, Muradi V, Hukkeri PA, Kunnavil R, Doreswamy V, Prakash VS, Murthy NS. Combination of music with lifestyle modification versus lifestyle modification alone on blood pressure reduction - A randomized controlled trial. Complement Ther Clin Pract. 2016 May;23:102-9. doi: 10.1016/j.ctcp.2015.05.004. Epub 2015 May 12.

    PMID: 26007202BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • MEDHA RAO, MD

    Rajiv Gandhi University of Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 25, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

July 30, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations

IN(1)