| CTRI Number |
CTRI/2019/08/020876 [Registered on: 23/08/2019] Trial Registered Prospectively |
| Last Modified On: |
22/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Translation of a questionnaire to self assess voice problems in transwomen from English to Malayalam. . |
|
Scientific Title of Study
|
Adaptation, Translation and Validation of male to female Transsexual Voice Questionnaire in Malayalam. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayisha Shoukheen K |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9686018960 |
| Fax |
|
| Email |
ayishamujeeb77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venkataraja U Aithal |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions,Manipal Academy of Higher Education (MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9380495415 |
| Fax |
|
| Email |
vrajaithal@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ayisha Shoukheen K |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE), Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9686018960 |
| Fax |
|
| Email |
ayishamujeeb77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of speech and hearing, Manipal College of Health Professions, MAHE, Manipal |
|
|
Primary Sponsor
|
| Name |
Ayisha Shoukheen K |
| Address |
Department of speech and hearing, Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE), Manipal |
| 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 |
| Ayisha Shoukheen K |
Kasturba Hospital |
Department of speech and hearing, Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE), Manipal
Udupi
KARNATAKA |
9686018960
ayishamujeeb77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college and kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F640||Transsexualism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1) People who were born as a male but are now leading a lifestyle of female for a minimum of 2 years; Trans gender male to female.
2) Both transsexuals and transgenders will be considered for the study.
3) Participants should be adults.
4) Literate in the Malayalam language.
|
|
| ExclusionCriteria |
| Details |
1) Trans genders below the age of 18.
2) Trans women diagnosed with severe psychiatric disorders and who are under medication for the same.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The internal consistency and the test retest reliability of the translated Malayalam Transsexual Voice Questionnaire (MtF). |
01-09-2019 TO 30-05-2020 |
|
|
Secondary Outcome
|
|
|
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)
|
30/08/2019 |
| 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
|
NOT YET DONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There is a significant increase in the number of
transsexuals/ transgenders in Indian context from the past one decade. With the
increase in public awareness and growing legal acceptance of various problems
of this population, it becomes necessary to implement standardised method of
clinical evaluation.
Though there are a few voice centres in India
practicing voice evaluation and therapy in transsexual, no attempts have been
reported to develop a self-perceptual questionnaire on voice of transsexuals. In
this context, in order to provide appropriate counselling and meaningful
intervention, it becomes a necessity to adapt and validate the Transsexual
Voice Questionnaire to Malayalam. |