| CTRI Number |
CTRI/2025/09/094839 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Indian classical music and white noise] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
listening to music or noise what happens to your heart |
|
Scientific Title of Study
|
Effect of Indian Classical Music and White Noise on Heart Rate Variability hy And Blood Pressure: A Comparative Study |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Sumentha Dsouza |
| Designation |
post graduate |
| Affiliation |
goa medical college |
| Address |
Physiology Department, 4th Floor, Superspeciality Block, Goa Medical College, North Goa.
North Goa
GOA
403202
India |
| Phone |
09922254482 |
| Fax |
|
| Email |
drsumentha11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sandip Sardessai |
| Designation |
Professor and HOD |
| Affiliation |
Goa medical college |
| Address |
Physiology Department, 4th Floor, Room No 43, Superspeciality block,Bambolim, North Goa - 403202
North Goa
GOA
403202
India |
| Phone |
9823209814 |
| Fax |
|
| Email |
dr.sandipsardessai@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
sumentha dsouza |
| Designation |
post graduate |
| Affiliation |
goa medical college |
| Address |
goa medical college bambolim goa
North Goa
GOA
403404
India |
| Phone |
09922254482 |
| Fax |
|
| Email |
drsumentha11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sumentha DSouza |
| Address |
Physiology Department, 4th Floor, Superspeciality block, Goa Medical College, Bambolim, North Goa, Goa - 403202 |
| 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 |
| DrSumentha Dsouza |
Goa Medical College |
Physiology Department, 4th Floor, Room No 43, Superspeciality block,Bambolim, North Goa - 403202
North Goa
GOA |
09922254482
drsumentha11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| goa medical college institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NORMAL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Indian Classic Music and White Noise music |
Participants will be exposed to pre-recorded Indian classical instrumental music through headphones at comfortable volume (50–60 dB) for 20 minutes in a quiet room.
Participants will be exposed to standardized white noise through headphones at the same volume (50–60 dB) for 20 minutes in a quiet room. |
| Intervention |
Music Therapy |
Silent versus Indian classical versus White noise |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
first year medical students in the age group of 18-25years and who are willing to give consent will be enrolled |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in heart rate variability parameters and blood pressure before and after exposure/intervention |
at baseline and immediately post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
27/09/2025 |
| 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="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
my study is on effect of indian classical music and white noise on HRV and BP a comparative study aim and objective of study is to compare effects of indian classical music and white noise on frequency domain measures of heart rate variability and blood pressure in medical students sample size is 53 students instruments to be used are lmh physiograph and bp apparatus |