| CTRI Number |
CTRI/2025/09/094515 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Vocal Fatigue and Its Impact on Voice Use, Participation, and Quality of Life among Pediatric Speech-Language Pathologists in India |
|
Scientific Title of Study
|
Assessing the relationship between vocal fatigue and voice activity, participation, and quality of life among pediatric SLPs practicing in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharsha Poojya |
| Designation |
Postgraduate student pursuing MSc in Speech Language Pathology |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
6374981744 |
| Fax |
|
| Email |
dharsha.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Devadas |
| Designation |
Additional Professor, Head of Department |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448930882 |
| Fax |
|
| Email |
usha.d@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha Devadas |
| Designation |
Additional Professor, Head of Department |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448930882 |
| Fax |
|
| Email |
usha.d@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dharsha Poojya |
| Address |
Department of speech and hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka- 576104 |
| 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 Usha Devadas |
Manipal College of Health Professions |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA |
9448930882
usha.d@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Practicing Pediatric Speech Language Pathologists |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Practicing pediatric speech-language pathologists in India, working for at least six months and
regularly use their voice for a minimum of 4 hours/day.
2. Pediatric SLPs of both genders, aged 22 years and above, currently in practice. |
|
| ExclusionCriteria |
| Details |
• SLPs who are diagnosed with voice disorder (e.g., vocal nodules, laryngitis) and are currently
receiving treatment or therapy for vocal fatigue or voice-related conditions.
• SLPs who have a history of neurological conditions, head or neck surgery, or any condition
affecting vocal function. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of the presence and severity of vocal fatigue symptoms among pediatric SLPs in India, and their impact on voice activity, participation, and overall quality of life. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of associations between vocal fatigue and demographic or professional factors (e.g., age, years of experience, work setting, geographical region), and subgroup comparisons to identify variations in impact. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="337"
Sample Size from India="337"
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)
|
21/09/2025 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Justification for the study: Pediatric SLPs rely
heavily on their voice to provide therapy, making them vulnerable to vocal fatigue, which affects both
professional efficiency and quality of life. Despite its prevalence, research on vocal fatigue among
pediatric SLPs in India is limited. Studying its impact can inform workplace modifications and
educational programs to support their longevity in the field.
Aim and Objectives of the study: The aim of the study is to assess the relationship
between vocal fatigue symptoms on voice-related activities and participation and self-perceived impact
on quality of life among speech-language pathologists (SLPs) working with pediatric populations in
India and this study further aims to identify occupational and environmental factors contributing to
vocal fatigue in SLPs, as well as common coping mechanisms and preventive measures they employ
to manage vocal health.
|