| CTRI Number |
CTRI/2017/12/011005 [Registered on: 28/12/2017] Trial Registered Prospectively |
| Last Modified On: |
27/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of how any kind of a voice problem can affect the singing performance in Church choir singers using a Voice handicap questionnare |
|
Scientific Title of Study
|
Evaluation of impact of voice problem on the singing performance in church choir singers using Singing Voice Handicap Index. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANNETT PONNU VARGHESE |
| Designation |
POST GRADUATE |
| Affiliation |
SCHOOL OF ALLIED HEALTH SCIENCES, MANIPAL UNIVERSITY |
| Address |
DEPARTMENT OF SPEECH AND HEARING , SCHOOL OF ALLIED HEALTH SCIENCES, MANIPAL UNIVERSITY, MANIPAL- 576104
DEPARTMENT OF SPEECH AND HEARING , SCHOOL OF ALLIED HEALTH SCIENCES, MANIPAL UNIVERSITY,MANIPAL-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9731569914 |
| Fax |
|
| Email |
annetteponnu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Guide Dr Usha Devadas |
| Designation |
Associate Professor |
| Affiliation |
SCHOOL OF ALLIED HEALTH SCIENCES, MANIPAL UNIVERSITY |
| Address |
DEPT OF SPEECH AND HEARING, SCHOOL OF ALLIED HEALTH SCIENCES, MANIPAL UNIVERSITY, MANIPAL-576104
ASSOCIATE PROFESSOR ,DEPT OF SPEECH AND HEARING , MANIPAL UNIVERSITY, MANIPAL-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9448930882 |
| Fax |
|
| Email |
usha.d@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
ANNETT PONNU VARGHESE |
| Designation |
POST GRADUATE |
| Affiliation |
SCHOOL OF ALLIED HEALTH SCIENCES, MANIPAL UNIVERSITY |
| Address |
DEPT OF SPEECH AND HEARING, SCHOOL OF ALLIED HEALTH SCIENCES ,MANIPAL UNIVERSITY, MANIPAL-576104
GUIDE - ASSOCIATE PROFESSOR, DEPT OF SPEECH AND HEARING, SCHOOL OF ALLIED HEALTH SCIENCES, MANIPAL UNIVERSITY,MANIPAL-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9731569914 |
| Fax |
|
| Email |
annetteponnu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ANNETT PONNU VARGHESE |
| Address |
DEPT OF SPEECH AND HEARING, SCHOOL OF ALLIED HEALTH SCIENCES, MANIPAL UNIVERSITY, MANIPAL |
| Type of Sponsor |
Other [NIL ] |
|
|
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 |
| ANNETT PONNU VARGHESE |
DEPT OF SPEECH AND HEARING |
DEPARTMENT OF SPEECH AND HEARING , SCHOOL OF ALLIED HEALTH SCIENCES , MANIPAL UNIVERSITY, MANIPAL-576104
Udupi
KARNATAKA |
9731569914
annetteponnu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PRIMARY HEALTH CONDITION IS VOICE PROBLEM IN CHURCH CHOIR SINGERS AND ITS IMPACT ON SINGING PERFORMANCE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PARTICIPANTS WHO ARE BETWEEN 18 AND 60 YEARS OF AGE |
|
| ExclusionCriteria |
| Details |
PARTICIPANTS WHO ARE UNDER 18 YRS OF AGE. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WITH THE HELP OF THE INDEX USED HERE, WE CAN DETERMINE THE MEAN AND THE STANDARD DEVIATION OF THE SCORES OBTAINED |
FEBRUARY 2018- AFTER THE DATA COLLECTION AND DATA ENTRY, OUTCOME MEASUREMENT WILL BE DONE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CAN PROVIDE THE SINGERS WITH AWARENESS OF THE EXISTING VOICE PROBLEM AND CAN GIVE REMEDIATION STRATEGIES |
ONE TIME POINT |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
30/12/2017 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THE STUDY IS GOING TO BE CONDUCTED IN CHURCH CHOIR SINGERS IN AND AROUND MANIPAL AND UDUPI IN KARNATAKA. THE STUDY PERIOD FOR THE RECRUITMENT OF PARTICIPANTS WILL BE FROM DECEMBER END TO JANUARY END. |