| CTRI Number |
CTRI/2025/08/093654 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A test in Kannada for people who feel things strongly |
|
Scientific Title of Study
|
Translation and Validation of the Highly Sensitive Person Scale into Kannada |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Monica A |
| Designation |
Post graduate students |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9345708878 |
| Fax |
|
| Email |
monica.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Bhargavi P G |
| Designation |
Assistant Processor - Selection grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7676792550 |
| Fax |
|
| Email |
bhargavi.pg@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Bhargavi P G |
| Designation |
Assistant Processor - Selection grade |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7676792550 |
| Fax |
|
| Email |
bhargavi.pg@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions(MCHP), Manipal Academy of Higher Education(MAHE), Manipal-576104 |
|
|
Primary Sponsor
|
| Name |
Monica A |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal-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 Hari Prakash |
Kasturba Hospital, Manipal |
Room no:27, Audiology OPD, Kasturba Hospital, MAHE, Manipal-576104
Udupi
KARNATAKA |
9886135522
hari.prakash@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Without any systemic illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Individuals must be proficient in reading and writing Kannada, with a minimum qualification of SSLC |
|
| ExclusionCriteria |
| Details |
Individuals with any systemic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HSP Scale - Kannada version |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="270"
Sample Size from India="270"
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)
|
06/10/2025 |
| 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) |
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 Kannada version of the Highly Sensitive
Person (HSP) scale will be translated and validated through a structured process. Two bilingual translators will independently translate the
scale into Kannada, and their versions will be reconciled into a single draft.
An independent bilingual translator will then perform a back-translation to
ensure accuracy of meaning. A review committee will assess the translations for
clarity, consistency, and cultural relevance. The finalized version will be
evaluated by a panel of professionals, including audiologists, a Kannada
language expert, and a linguist, to check naturalness, clarity, and
appropriateness. Following this, cognitive debriefing with native Kannada
speakers will be conducted to confirm understanding. The refined version will
then be field-tested with 270 participants, including bystanders at the
Audiology OPD, to confirm its reliability and applicability. |