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CTRI Number  CTRI/2024/01/061408 [Registered on: 12/01/2024] Trial Registered Prospectively
Last Modified On: 03/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Survey on Noise exposure at workplace 
Scientific Title of Study   Translation and Validation of the Noise Exposure Questionnaire in Kannada 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kaveramma SS 
Designation  Student 
Affiliation  Manipal college of health professions 
Address  Department of Speech and Hearing, Room no 404, Manipal college of Health Professions, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  09480766716  
Fax    
Email  komalkaveramma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bhargavi P G  
Designation  Assistant Professor(selection grade) 
Affiliation  Manipal college of health professions 
Address  Department of Speech and Hearing, Manipal college of Health Professions, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  7676792550  
Fax    
Email  bhargavi.pg@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Bhargavi P G  
Designation  Assistant Professor(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 
 
Primary Sponsor  
Name  Self Financed 
Address  101 Nehru Hostel Manipal 576104 
Type of Sponsor  Other [Self financed] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ms Bhargavi P G  Manipal College of Health Professions  Pre clinical room, Department of Speech and Hearing, Room nuber 416, MCHP, MAHE, Manipal.
Udupi
KARNATAKA 		 7676792550

bhargavi.pg@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(Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No serious systemic illness. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  : Phase 1: Translation and Validation of the Questionnaire.
Inclusion criteria: Four bilingual translators(Two English to Kannada and 2 Kannada to English
translators) of either gender with five years of work experience, 3 Audiologists and 2 Linguists.
Phase 2: Pilot study. Inclusion criteria: 30 Kannda speaking adults between the age of 18- 30 years.
Phase 3: Hearing screening and administration of the Questionnaire. Inclusion criteria: Industrial
workers between the age of 18 to 50 years with and without hearing loss exposed to nose levels of
85dBA for 8 hours per day. Individuals who can read and write Kannada 
 
ExclusionCriteria 
Details  Individuals with systemic illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Annual Noise Exposure levels   One time 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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)   31/01/2024 
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   Phase 1: Johnson et al. established the first NEQ in 2017 to calculate each person’s yearly noise exposure, which includes workplace and daily exposures. The translation procedure will be carried out by utilizing the International Test Committee 2013 guidelines with the informed consent of Dr. Johnson’s team. Step 1: Forward and Backward translation. Two bilingual translators independently translate the original English questionnaire into Kannada. Then bilingual expert team compares the two versions of the translation, and a preliminary version of the K-NEQ is obtained. The preliminary version of the K-NEQ is to be translated back into English by two independent English majors. Back translation with the original NEQ is done to ensure its meanings are consistent. Step 2: Content Validation. This step involves 3 audiologists and 2 linguits to rate the content of the questionnaire in 5 point rating scale (1- completely irrelevant; 5- completely relevant). Open response regarding any other suggestions for every question is allowed. Phase 2: Involves Pilot study with 30 Kannada speaking adults between 18-30 years of age. Final score less than 79 is considered as a valid questionnaire. 20%of the population will be retested after two weeks to check for the test retest reliability.Phase 3: Hearing screening and administration of the questionnaire. Approval from the manufacturing industry will be obtained to proceed with the study. Employees are recruited from Varun piping System Manipal, AC plant KMC Manipal, Karnataka closures private limited, Udaya kitchen crafts Manipal. Obtaining appropriate consent from the participants chosen for the study to proceed with hearing screening which is followed by Otoscopic examination. Hearing screening of all the subjects will be conducted prior to questionnaire using portable audiometer. Pure tone average will be obtained for air conduction thresholds at 500, 1k, 2k and 4k frequencies respectively by adapting Hughson Westlake method using a calibrated audiometer and headphones. Each participant will be asked to complete the self reported NEQ that requires approximately ten minutes to respond to the questions. Participants are instructed to recollect instances of participating in noisy activities over the course of a year. Average is calculated by adding individual responses to each question and obtaining the number of hours spent on each noisy activity. Overall annual noise exposure levels are estimated by combining Episodic and Routine exposures. Those with annual noise exposure level values of more than 79 are considered to be at risk for NIHL using the NIOSH occupational noise limit of 85 dB exposure level with a 3 dB exchange rate. 
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