| CTRI Number |
CTRI/2024/06/069206 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on the autonomic Effects of Indian Classical Music on Healthy Young Individuals |
|
Scientific Title of Study
|
A Randomised Controlled Trial on the Autonomic and Cardiovascular Effects of Indian Classical Music on Young Healthy Individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PIMSRC/E1/388A/89/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreelakshmi K |
| Designation |
MD Resident |
| Affiliation |
Department of Physiology, Pushpagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Physiology
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla-689101
Pathanamthitta
Kerala
Pathanamthitta
KERALA
689101
India |
| Phone |
919400455458 |
| Fax |
|
| Email |
sreelakshmikoliyot576@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Amrutha Mary Zachariah |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Physiology
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla-689101
Pathanamthitta
Kerala
Pathanamthitta
KERALA
689101
India |
| Phone |
918281748411 |
| Fax |
|
| Email |
marymitha100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sreelakshmi K |
| Designation |
MD Resident |
| Affiliation |
Department of Physiology, Pushpagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Physiology
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla-689101
Pathanamthitta
Kerala
Pathanamthitta
KERALA
689101
India |
| Phone |
919400455458 |
| Fax |
|
| Email |
sreelakshmikoliyot576@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pushpagiri Institute of Medical Sciences and Research Centre |
|
|
Primary Sponsor
|
| Name |
Sreelakshmi K |
| Address |
Department of Physiology
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla-689101
Pathanamthitta
Kerala |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sreelakshmi K |
Pushpagiri Institute of Medical Sciences and Research Centre |
Department of Physiology
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla-689101
Pathanamthitta
Kerala
Pathanamthitta
KERALA |
919400455458
sreelakshmikoliyot576@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pushpagiri Institute of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cardiac autonomic functions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music (Raga Puriya)exposure |
A Ten-minute, pre-recorded instrumental rendition of raga
Puriya will be played via headphones connected to a laptop, at a uniform volume (50%).
During this ten minutes, the ECG will be recorded followed by recording of BP and pulse rate and the values will be noted. |
| Comparator Agent |
Nature sounds |
In the control group, natural
sounds (birds chirping and flowing river) will be played for 10 seconds duration once every 2 minutes during the recording. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Individuals of age 20-30 years
of either gender
medically and surgically healthy
give consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Smokers
Alcoholics.
Hypertensives
Participants on any medication known to affect the BP or autonomic status of the individual.
Pregnancy
Body mass index (BMI) more than 30 kg/m2
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Systolic Blood Pressure
Diastolic Blood Pressure
Pulse Pressure
Mean Arterial Blood Pressure
Heart Rate
Heart Rate Variability |
During music exposure-baseline
Post music exposure-10 minutes after baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised, double- blinded, parallel group, single centre study to know the effect of Indian classical music ( Raga Puriya) on cardiac autonomic functioning of healthy human volunteers.The parameters studied are Systolic Blood Pressure, Diastolic Blood Pressure, Pulse Pressure , Mean Arterial Blood Pressure, Heart Rate and Heart Rate Variability.After the baseline assessment, each participant will be randomized either into the experimental group or the control group using block randomization technique. A Ten-minute, pre-recorded instrumental rendition of raga Puriya will be played via headphones connected to a laptop, at a uniform volume (50%) to the experimental group.In the control group ,natural sounds (birds chirping and flowing river) will be played for 10 seconds duration once every 2 min. The Systolic Blood Pressure, Diastolic Blood Pressure, Pulse Pressure , Mean Arterial Blood Pressure, Heart Rate and Heart Rate Variability will be recorded during and post music interventions and compared between two groups using T test and ANOVA. |