CTRI Number	CTRI/2021/09/036988 [Registered on: 30/09/2021] Trial Registered Prospectively
Last Modified On:	29/09/2021
Post Graduate Thesis	Yes
Type of Trial	Observational
Type of Study	Cross Sectional Study
Study Design	Other
Public Title of Study	Public awareness questionnaire on hearing health and hearing loss
Scientific Title of Study	Cultural adaptation and administration of public awareness questionnaire on hearing health and hearing loss in Karnataka
Secondary IDs if Any	Secondary ID  Registry  nil  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Jincy Mary Cherian  Address  Department of Speech and Hearing MCHP,MAHE,Manipal Udupi KARNATAKA 576104 India  Phone  9620728239   Fax     Email  jincy.cherian@learner.manipal.edu
Details Contact Person Scientific Query	Name  Ms Bhargavi PG  Address  Department of Speech and Hearing MCHP,MAHE,Manipal Udupi KARNATAKA 576104 India  Phone  9964237695   Fax     Email  bhargavi.pg@manipal.edu
Details Contact Person Public Query	Name  Ms Bhargavi PG  Address  Department of Speech and Hearing MCHP,MAHE,Manipal KARNATAKA 576104 India  Phone  9964237695   Fax     Email  bhargavi.pg@manipal.edu
Source of Monetary or Material Support	Kasturba Medical Hospital, Manipal
Primary Sponsor	Name  Jincy Mary Cherian  Address  Department of speech and hearing MCHP,MAHE Manipal  Type of Sponsor  Other [Self]
Details of Secondary Sponsor	Name  Address  Nil  nil
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Jincy Mary Cherian  Kasturba Hospital Manipal  Department of Speech and Hearing, Audiology Room, Room no.27, MCHP, MAHE, Manipal Udupi   9620728239 jincy.cherian@learner.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	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Healthy Individuals
Intervention / Comparator Agent	Type  Name  Details  Intervention  nil  nil
Inclusion Criteria	Age From  20.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  Must know either Kannada or English age range- between 20-60 male and female residing in Karnataka for more than 3 years
ExclusionCriteria	Details  NIL
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Not Applicable
Primary Outcome	Outcome  TimePoints  Early identification and early intervention can be initiated. Depending on their awareness level we can improvise on educating and spreading awareness about the hearing health & hearing loss by promoting more hearing loss campaigns camps and through print media   at baseline
Secondary Outcome	Outcome  TimePoints  nil  nil
Target Sample Size	Total Sample Size="720" Sample Size from India="720"
Phase of Trial Modification(s)	N/A
Date of First Enrollment (India)	21/10/2021
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="10" Days="0"
Recruitment Status of Trial (Global)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details	nil
Brief Summary	Phase 1-Translation, cultural adaptation and validation of the questionnaire   Study setting: Manipal College of health profession; Manipal. Study participants: 5 Audiologists, 2 Kannada-English bilingual speakers, 10 subjects Content validation ·       The assessment tool is adapted from the questionnaire used in “public awareness of ear and hearing management as measured using a specific questionnaire” created by Federica et al., 2013 ·       The questionnaire will be given to five experienced audiologists for the validation of the content based on relevance, comprehensibility, complexity. ·       The opinion on each item from the questionnaire will be obtained by asking them to rate each item on the 3-point rating scale with 0 – not important ,1- important with modification, 2 -very important. Translation and Cultural Adaptation of the questionnaire ·       Step1: Translation into the target language from the original language (forward translation): The modified English version of the questionnaire will be given to a proficient Kannada-English bilingual speaker for English to Kannada translation ·       Step2: Translating back into the original language from the target language (back translation): The translated Kannada version of the questionnaire will be given to another proficient Kannada-English bilingual speaker for back translating it to English ·       Step3: Committee review: The translated questionnaires will be compared to the original questionnaire to ensure that the forward and back translations are accurate and to overcome any differences. ·       Step4: Field testing: a pilot study will be carried out with 10 participants to ensure for comprehensibility of the questions and whether they are culturally appropriate and final amendments will be done. A final translation certificate to be issued to confirm the process ·       The questionnaire, will be divided into 4 parts o   Knowledge about infant hearing loss o   Cleaning and treating the ear o   Effect of overexposure to noise and loud sounds. o   Diagnostic delay.   Phase 2-Administration of the questionnaire   Study Setting: Online Study participants: Participants residing in Karnataka with the age range between 20-60 years. Administration ·       Informed consent prior administration of the questionnaire will be given · The questionnaire will be administered and circulated to the participants visiting the Audiology department OPD of Kasturba Hospital and CTC of MCHP, Manipal via google forms. · The questionnaire would be given in google forms depending on the language preference of the individual. · The responses will be collected from the participants residing from the districts in Karnataka that are Dakshina Kannada, Ballari, Dharwad, Mysuru, Bangalore, Udupi, Shimoga, Belgaum, Davanagere, Chikmagalore, Bijapur and Uttara Kannada. · Demographic details will be captured in google form & patient information form which includes name, age, gender, occupation, and educational background. ·       Results obtained from the study would be statistically analyzed and appropriate inferences is drawn