| CTRI Number |
CTRI/2025/08/093703 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effects of Breathing Exercises on Lung Function and Performance Anxiety in Singers of Delhi NCR |
|
Scientific Title of Study
|
Effects of Inspiratory Muscle Training Versus Semi Vocal Occlusion Therapy on Lung Functions and Performance Anxiety in Hindustani Classical Vocalists of Delhi-NCR: A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BARNALI BHATTACHARJEE |
| Designation |
Ph.D Scholar |
| Affiliation |
GD Goenka University |
| Address |
GD Goenka University
Sohna Road, Gurugram , Haryana
Sohna Road, Gurugram, Haryana: 122103
Gurgaon
HARYANA
122103
India |
| Phone |
7896224137 |
| Fax |
|
| Email |
barnali2734@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTabish Fahim |
| Designation |
Associate Professor |
| Affiliation |
GD Goenka University |
| Address |
GD Goenka University
Sohna Road, Gurugram , Haryana
Gurgaon
HARYANA
122103
India |
| Phone |
9718481337 |
| Fax |
|
| Email |
tabish.fahim@gdgu.org |
|
Details of Contact Person
Public Query
|
| Name |
Barnali Bhattacharjee |
| Designation |
Ph.D Scholar |
| Affiliation |
GD Goenka University |
| Address |
GD Goenka University
Sohna Road, Gurugram , Haryana
Gurgaon
HARYANA
122103
India |
| Phone |
7896224137 |
| Fax |
|
| Email |
barnali2734@gmail.com |
|
|
Source of Monetary or Material Support
|
| Musical Minds School of Music
Dwarka Mor, New Delhi-110059 |
|
|
Primary Sponsor
|
| Name |
Barnali Bhattacharjee |
| Address |
GD Goenka University
Sohna Road, Gurugram, Haryana 122103 |
| 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 |
| Barnali Bhattacharjee |
Musical Minds School of Music |
A36,Rama Park, Dwarka Mor
New Delhi 110059
West
DELHI |
9911522622
barnali2734@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Waves Women Empowerment Trust |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hindustani Classical Vocalists |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Group 3 has control group which is having educational booklets of all the exercises |
| Intervention |
Inspiratory Muscle training, SVOT and Breathing exercises, ,combining IMT,SVOT and Breathing Exercises |
Group 1 is Inspiratory muscle training
Group 2 is SVOT and Breathing exercises
Group 4 is combining IMT,SVOT and Breathing Exercises |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Hindustani Classical Vocalists practicing 1 hour or more for atleast 5 years
FEV1 AND FVC Ratio greater than 75 percent.
Good general health
Willing to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Current respiratory illness
Recent shoulder or thoracic injuries
Use of medications for anxiety or respirtory conditions
Current voice impairement
Current or history of smoking
Participation in similar studies in last six months |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lung Functions like FEV1,FVC,FEV1 and FVC Ratio,PEFR, RR,HR,TV |
Pre and post Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mazzarolo Music Performance Anxiety Scale, Singers Voice Handicap Index, Maximum Phonation Time, Maximum Voluntary Ventilation |
Pre and post Intervention |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| Date of Study Completion (India) |
31/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Current research on inspiratory muscle
training (IMT) often groups musicians together without considering their
instrument-specific respiratory demands, despite differences between vocalists,
brass, and woodwind players. While studies highlight IMT’s physiological
benefits, its impact on psychological factors like performance anxiety remains
underexplored. Additionally, there is a lack of direct comparisons between IMT
, SVOT and traditional breathing exercises, making it unclear which approach is
more effective or whether a combination yields the best results. Addressing
these gaps could provide more tailored and comprehensive insights into IMT’s
benefits for Vocalists
|