| CTRI Number |
CTRI/2025/07/091360 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Voice measures among carnatic singers |
|
Scientific Title of Study
|
EFFECTIVENESS OF ABHYASA GANA ON VOICE MEASURES AMONG CARNATIC SINGERS MIXED METHOD 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 |
Nireeksha U K |
| Designation |
Ph D scholar |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Audiology and Speech Language Pathology
Kasturba Medical College, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8296517018 |
| Fax |
|
| Email |
nireeksha.kmcmlr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Radish Kumar B |
| Designation |
Professor |
| Affiliation |
Katurba Medical College, Mangalore |
| Address |
Department of Audiology and Speech Language Pathology
Kasturba Medical College, Mangalore
Kasturba Medical College, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
6361212929 |
| Fax |
|
| Email |
radheesh.slp@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Nireeksha U K |
| Designation |
Ph D scholar |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Audiology and Speech Language Pathology
Kasturba Medical College, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8296517018 |
| Fax |
|
| Email |
nireeksha.kmcmlr2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nireeksha U K |
| Address |
Department of Audiology and Speech Language Pathology
Kastruba Medical College
Mangalore
Karnataka 575004 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nireeksha U K |
Community based intervention, Kasturba Medical College, Hospital |
KMC hospital
Attavar
Mangalore
Dakshina Kannada
KARNATAKA |
8296517018
nireeksha.kmcmlr2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy female carnatic singers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abhyasa Gana |
Provides structured warm-up module for Carnatic singing by integrating the pedagogical principles of Carnatic music with the exercise physiology principles of speech-language pathology and provides Vocal Hygiene program for 30 minutes for 12 sessions |
| Comparator Agent |
Vocal Hygiene Program |
The participant will be advocated and asked to follow the Vocal hygiene program for 30 minutes and 12 sessions |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Female Carnatic singers including adolescence and young adulthood between the age range of 16-40 years according to Erickson’s re-envisaged eight Stages of Psychosocial Development
Formally trained singer for the past 3 years
Practice singing at least 4 hours a week
Normal voice according to Consensus Auditory-Perceptual Evaluation of Voice- Revised (CAPE-Vr)
Minimum educational requirement of secondary school education
|
|
| ExclusionCriteria |
| Details |
Male Carnatic singers
Performing heavy singing practice for the concert
History or diagnosed hearing impairment hormonal imbalance neurological psychiatric or psychological issues.
Women in perimenopausal and post menopausal stages
Women who are pregnant and those during the menstrual phase
No history or presence of voice problems
No history of parturition and lactation in the last one year
No history of smoking or alcohol consumption
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Cepstral Peak Prominence
2) Smooth Cepstral Peak Prominence
3) Formant Frequency- F1 to F4
4) Difference between F0 and F1
5) Singing Frequency Range
6) Evaluation of Ability to Sing Easily
7) Singing Voice Handicap Index
8) C) Subjective reflections of participants regarding the practice of structured warm-up regimen (vocal and non-vocal) using a Likert scale
|
Baseline and Follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/09/2026 |
| 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="2"
Months="0"
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
|
The researcher will contact the music schools in and around Dakshina Kannada district India and will inform the music teachers regarding the purpose of the study. The researcher will collect the personal details of the intermediate singing students who have completed the junior grade examination willing to participate in the study. Those selected students who are trained carnatic singers will be contacted personally via phone call to explain the purpose and procedure of the study. During this call the researcher will also inquire about the participants willingness to participate in the study. The study will commence only after obtaining written consent from the participant.
A baseline evaluation will be performed before an intervention program. The two groups of singers will be instructed to refrain from performing any vocal exercises or their regular vocal routine before the baseline evaluation to ensure their natural voice and laryngeal structure are accurately represented. The effect of confounding variables will be controlled by instructing them not to consume spicy food, caffeine alcohol tobacco and drink less than 6-7 glasses of water daily.
Following the baseline assessment participants in the experimental group will be undergo structured warm-up regimen (vocal and non-vocal) which has been compiled in the module. These warm-up regimen will be conducted at their music institution under the guidance of the researcher for 12 consecutive days before formal singing training begins. The researcher will implement the intervention by grouping the participants into sets of two. The participants will be instructed to perform the exercises only under the guidance of the researcher to maintain consistency and minimize practice effects. Each intervention session will last approximately 30 minutes. Participants who do not complete 12 days of intervention will be eliminated from the study.
|