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临床试验/CTRI/2024/01/061408
CTRI/2024/01/061408尚未招募不适用

Translation and Validation of the Noise Exposure Questionnaire in Kannada

Self Financed1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2024年1月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
170
试验地点
1
主要终点
Annual Noise Exposure levels

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • : 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.

排除标准

  • Individuals with systemic illness.

结局指标

主要结局

Annual Noise Exposure levels

时间窗: One time

次要结局

  • Not Applicable(Not Applicable)

研究者

发起方
Self Financed
申办方类型
Other [Self financed]
责任方
Principal Investigator
主要研究者

Kaveramma SS

Manipal college of health professions

研究点 (1)

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