| CTRI Number |
CTRI/2025/08/092319 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the knowledge of caretakers regarding the social and emotional problems faced by individuals with hearing loss. |
|
Scientific Title of Study
|
Development and validation of a tool to measure the communication partners’ knowledge and attitudes toward the psychosocial effects of hearing loss in middle-aged adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushi Mukundha |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9972329284 |
| Fax |
|
| Email |
khushi2.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Kanaka |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845384136 |
| Fax |
|
| Email |
g.kanaka@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Kanaka |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845384136 |
| Fax |
|
| Email |
g.kanaka@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, MAHE, Manipal 576104, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Khushi Mukundha |
| 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 G Kanaka |
Kasturba Hospital |
Room no 27, 2nd Floor, Audiology OPD clinic, MAHE, Manipal,576104 Karnataka, India
Udupi
KARNATAKA |
9845284136
g.kanaka@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 |
Family and friends of Person with hearing loss |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Communication partners of middle-aged persons between 30 to 55 years with hearing loss Communication Partners can be someone residing in the same house, such as a spouse, parent, friend, coworker, grandparent, family member living nearby, or children above 18 years of age.
2. English speaking proficiency.
3. Completion of at least eighth grade basic education.
4. Duration of relationship should be Minimum of two years.
5. Type of hearing loss of the person with hearing impairment can Bilateral sensorineural hearing loss or bilateral mixed hearing loss.
6. Severity of hearing loss must be Mild degree or greater.
7. Duration of hearing loss must be Minimum of two years.
8. Communication partner of the person with hearing impairment may be with or without the use of an amplification device
|
|
| ExclusionCriteria |
| Details |
No other comorbidities like psychological and neurological deficits based on medical history |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge and attitude questionnaire |
Once at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
14/08/2025 |
| 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="9"
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
|
This study aims to develop and validate a tool to measure communication partners’ knowledge and attitudes toward the psychosocial effects of hearing loss in middle-aged adults. The initial development of the questionnaire will be carried out through an extensive literature review to identify relevant domains and generate items. Following this, a focus group discussion (FGD) will be conducted involving communication partners, audiologists, and a psychologist to explore issues, experiences, and awareness related to hearing loss. This session will be audio-recorded, and written informed consent will be obtained from all participants prior to their involvement. The inputs from the FGD will guide the modification and refinement of the questionnaire. A second FGD will then be conducted with a different panel of experts, to carry out content validation and ensure clarity, relevance, and comprehensiveness of the tool. FGDs might take around 30 minutes to 1 hour. Subsequently, the validated questionnaire will be pilot tested on 30 communication partners of middle-aged adults with hearing loss to assess clarity, feasibility, and internal consistency reliability. The communication partners of individuals with hearing impairment who visit Department of Speech and Hearing, Kasturba Hospital for routine audiological evaluation and hearing aid trial/ finetuning will be recruited. Participants will be chosen if they fit into the inclusion criteria and consent to the study. After consenting to the study the developed questionnaire will be administered to the participants. Thematic analysis will be used for FGD data, while descriptive statistics and reliability analysis will be conducted for pilot testing data. The developed tool will be culturally relevant and aid in improving the psychosocial health of the PHI and CP. The questionnaire can be a tool for spreading awareness to the communication partners regarding the psychosocial effects of hearing loss. |