| CTRI Number |
CTRI/2026/01/100333 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Voice Exercises Along with Physiotherapy in Reducing Voice Tiredness in School Teachers. |
|
Scientific Title of Study
|
Effect Of Vocal Function Exercise Protocol With Conventional Physiotherapy On Vocal Fatigue In School Teachers : 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 |
Gokani Pushti Ashishbhai |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK UNIVERSITY |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot. Gujarat, India. Rajkot GUJARAT 360020 India
Rajkot
GUJARAT
360020
India |
| Phone |
9687540165 |
| Fax |
|
| Email |
pgokani995@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Sojitra MPT Phd Scholar |
| Designation |
Assistant Professor , School Of Physiotherapy, RK University |
| Affiliation |
School of Physiotherapy, RK UNIVERSITY |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot. Gujarat, India. Rajkot GUJARAT 360020 India
Rajkot
GUJARAT
360020
India |
| Phone |
9427110124 |
| Fax |
|
| Email |
namrata.sojitra@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Gokani Pushti Ashishbhai |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK UNIVERSITY |
| Address |
Research Department, Room no. 207, School of Physiortherapy, RK University kasturbadham Rajkot-Bhavnagar Highway, Rajkot. Gujarat, India. Rajkot GUJARAT 360020 India
Rajkot
GUJARAT
360020
India |
| Phone |
9687540165 |
| Fax |
|
| Email |
pgokani995@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, RK University, Kasturbadham, Rajkot-Jamnagar Highway , Rajkot , Gujarat 360020 India |
|
|
Primary Sponsor
|
| Name |
School Of Physiotherapy RK University |
| Address |
School of Physiotherapy, RK UNIVERSITY, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat,360020 India |
| 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 Pushti Ashishbhai Gokani |
RK Physiotherapy Rehabilitation and Research center |
Physiotherapy Department, Room no 1 opp Meghani rang bhuvan,Bhaktinagar circle Raikot, Gujarat, India Rajkot GUJARAT Rajkot GUJARAT
Rajkot
GUJARAT |
09687540165
pgokani995@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, School Of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vocal fatigue, School Teachers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
The participants will receive only the conventional physiotherapy program consisting of:
Stretching and relaxation exercises for upper limb and cervical muscles
Breathing training (diaphragmatic breathing with and without phonation)
Resonance/phonation training (fricatives /s/, /z/, lip/tongue trills, humming)
Frequency & Duration:
5 days per week for 6 weeks. |
| Intervention |
Vocal Function Exercise Protocol + Conventional Physiotherapy |
1. Vocal Function Exercise Protocol, including
Sustained /i/ phonation
Pitch gliding (upward and downward) using /o/ or lip trill
Adductory power exercises on musical notes (C–G)
2. Conventional Physiotherapy, including
Stretching and relaxation exercises (upper limb and cervical region)
Breathing training (diaphragmatic breathing and breathing with phonation)
Resonance/phonation training (fricatives /s/, /z/, lip/tongue trills, humming)
Frequency & Duration:
5 days per week for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
School teachers both male and female aged between 25 and 55 years.
Minimum of 3 years of teaching experience.
Teaching atleast 5 hours daily for 6days/weeks.
Willingness to participate and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Teachers with Cognitive Impairment that affect communication.
Recent upper respiratory tract infections.
Neurological conditions affecting voice production.
Current smokers or individuals with a history of smoking in the past year. And Excessive Alcohol Consumption.
Receiving additional speech therapy assistance while taking part in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vocal Fatigue Index (Vfi)
(Measured Pre- And Post-Intervention)
|
Pre Outcome (first day of training)
Post outcome after 6 weeks (last day of training) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/01/2026 |
| 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="0"
Months="5"
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 Study Aims To Evaluate The Effect Of A Vocal Function Exercise Protocol Combined With Conventional Physiotherapy On Vocal Fatigue Among School Teachers. Participants Will Be Randomly Allocated Into Two Groups. Outcomes Will Be Measured Using The Vocal Fatigue Index. |