| CTRI Number |
CTRI/2025/08/092321 [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
|
Reasons that affect social life in people with hearing loss in adults |
|
Scientific Title of Study
|
Factors influencing social engagement of middle-aged adults with hearing impairment |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shah Mahi Jatin |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Health Profession |
| Address |
Department of Speech and Hearing, Manipal College of Health Profession, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7738652382 |
| Fax |
|
| Email |
shah.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Kanaka |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Profession |
| Address |
Department of Speech and Hearing, Manipal College of Health Profession, 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 Profession |
| Address |
Department of Speech and Hearing, Manipal College of Health Profession, MAHE, Manipal
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 |
Shah Mahi Jatin |
| Address |
Department of Speech and Hearing, Manipal College of Health Profession, 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 |
| Dr G Kanaka |
Kasturba Hospital |
Room no 27, 2nd Floor, Audiology OPD clinic, MAHE
Manipal-576104
Karnataka
India
Udupi
KARNATAKA |
9845384136
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 |
| Patients |
(1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Severity of hearing loss- pure tone average of greater than 25dBHL at 500Hz, 1kHz, 2kHz - mild and
above degree of hearing loss
Acquired, bilateral sensorineural hearing loss.
Minimum duration of hearing impairment of 2 years.
Participant should know to read and write English |
|
| ExclusionCriteria |
| Details |
No psychological or neurological, physical deficits based on medical history.
Any disabling visual impairment (uncorrected) which may affect the results |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pure Tone Audiometry–Measures degree and type of hearing loss
Speech in Noise Test
Practitioner Assessment of Network Type–measures social support
Hearing Handicap Inventory for Adults–Measures social and emotional impact
Participation Scale–Assess work and social participation
Highly Sensitive Person Scale–Assess sensory and emotional sensitivity
Self-Efficacy for Situational Communication Management Questionnaire–Measures communication confidence
Kuppuswamy Scale–Assess socioeconomic status |
once at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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
|
Aim of the study: Factors influencing social engagement of middle-aged adults with hearing impairment. Objectives: 1. Assess the relationship between hearing impairment and social engagement in middle-aged adults. 2. Evaluate the impact of listening fatigue in mediating the relationship between hearing impairment and social engagement. 3. Evaluate the role of self-efficacy in mediating the relationship between hearing impairment and social engagement. 4. Investigate the influence of sensory processing sensitivity on social engagement in individuals with hearing impairment. 5. Analyze the effect of socioeconomic status on social engagement in middle-aged adults with hearing impairment. Participants will be recruited in the Department of Speech and Hearing, Kasturba Hospital through the routine referral from ENT. Participants will undergo routine audiological evaluations including Pure Tone Audiometry (PTA), Speech Audiometry, and Speech Perception in Noise (SPIN) testing. Additionally, as part of this study, only questionnaires will be administered which will take approximately 15 to 20mins. Participants fulfilling the inclusion criteria will be informed about the study, and those who consent to take part will sign the consent form. Questionnaires Administered: · Hearing Handicap Inventory for Adults (HHI-A) · Practitioner Assessment of Network Type (PANT) · Participation Scale · Highly Sensitive Person Scale (HSPS) · Self-Efficacy for Situational Management Questionnaire (SESMQ) · Kuppuswamy Socioeconomic Scale Timepoints-Once at baseline By identifying the key factors that impact social engagement, targeted interventions can be developed to improve social involvement and mental health outcomes among middle-aged persons with hearing impairment. Early detection and comprehensive management of hearing impairment can improve social interaction and general well-being, considering the aspects that have been discovered. |