| CTRI Number |
CTRI/2024/04/066418 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Immediate impact of music on autonomic functions in daibetics] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of music on autonomic function in diabetic patients |
|
Scientific Title of Study
|
Immediate impact of music on autonomic functions in diabetics: An interventional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bijusha B S |
| Designation |
First year Post Graduate |
| Affiliation |
Shri Atal Bihari Vajpayee Medical College and Research Institute Bangalore |
| Address |
4th floor Physiology Department
Shri Atal Bihari Vajpayee Medical College and Research Institute, Shivajinagar, Bangalore-560001
Bangalore
KARNATAKA
560001
India |
| Phone |
8848742203 |
| Fax |
|
| Email |
bijushabiji8888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaitra M S |
| Designation |
Associate Professor,Department of Physiology |
| Affiliation |
Shri Atal Bihari Vajpayee Medical College and Research Institute Bangalore |
| Address |
4th floor Physiology Department
Shri Atal Bihari Vajpayee Medical College and Research Institute, Shivajinagar, Bangalore-560001
Bangalore
KARNATAKA
560001
India |
| Phone |
9591988200 |
| Fax |
|
| Email |
Chaitra.msridhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bijusha B S |
| Designation |
First year Post Graduate |
| Affiliation |
Shri Atal Bihari Vajpayee Medical College and Research Institute Bangalore |
| Address |
4th floor Physiology Department
Shri Atal Bihari Vajpayee Medical College and Research Institute, Shivajinagar, Bangalore-560001
KARNATAKA
560001
India |
| Phone |
8848742203 |
| Fax |
|
| Email |
bijushabiji8888@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bowring and Lady Curzon Hospital, Shivajinagar, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Bijusha B S |
| Address |
4th floor Physiology Department
Shri Atal Bihari Vajpayee Medical College and Research Institute, Shivajinagar,Bangalore-560001 |
| 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 Bijusha B S |
Bowring and Lady Curzon Hospital Bangalore |
4th Floor Physiology Department
Shri Atal Bihari Vajpayee Medical College and Research Institute ,Bangalore -560001
Bangalore
KARNATAKA |
8848742203
bijushabiji8888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Shri Atal Bihari Vajpayee Medical College and Research Institute Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autonomic function test and
Music therapy |
Study period :- after attaining CTRI number - March 2026(20 minute session of music therapy with a flute music)
Frequency- AFT will be done twice(before and after music intervention)
Duration- 1 hour ( which includes 20 minutes of music) |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients volunteering for the study |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Herat rate, respiratory rate and autonomic function |
20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| If music therapy proves to be beneficial in diabetic patients, the subjects can follow music therapy for their autonomic wellbeing. |
The effect is assessed immediately after 20 minutes of listening to music |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
08/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/04/2024 |
| 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 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
|
This is an interventional study on immediate impact of music on autonomic functions in diabetics.Autonomic function test will be performed in diabetic patients to detect cardiac autonomic neuropathy. Music therapy will be given for 20 minutes and its immediate impact will be checked by performing autonomic function test again in diabetic patients detected with cardiac autonomic neuropathy. The primary outcome will be decrease in heart rate , respiratory rate and autonomic functions in diabetics. Secondary outcome will be music therapy improves the autonomic function in diabetic patients, the subjects can follow music therapy for their autonomic wellbeing. |