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临床试验/CTRI/2024/01/061741
CTRI/2024/01/061741尚未招募不适用

Exploratory study on listening related fatigue in individuals exposed to occupational noise in industrial setting

Jilsha M1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月26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
100
试验地点
1
主要终点
Sum of all subscale scores of different domains of Vanderbuilt Fatigue Scale. The results offer a

研究概览

简要总结

Fatigue is one of the most common non auditory effect in occupational noise exposed population.

According to previously done studies, listening related fatigue is an early symptom of noise induced hearing loss. Population with prolonged occupational noise exposure who has listening related fatigue are at high risk of NIHL.

Assessment of listening related fatigue using Indian version of Vanderbilt Fatigue Scale - Adult will help in identification of the people who are at risk of developing NIHL.

Hearing screening will be done using potable audiometer and otoscope. The audiometry is done using modified Hughson -Westlake method. Pure tone average for air conduction threshold will be obtained at 500 Hz, 1kHz, 2kHz and 4kHz frequencies.

A self-administered one-minute noise screening is done. The subject is instructed to select any single option and the options given are never, every few months, monthly, weekly and daily. The scores range from 0 for never and 4 for daily. The noise score is calculated by calculating the sum of scores obtained in 3 questions. Scores of 0 to 4 represents lower risk and 5 and above represents higher risk. Subjects with higher risk and noise exposure of 85 dBA for 8 hours will be selected for the study.

Individuals under medication and treatments like chemo, radiation therapy, pain killers, heart drugs and antidepressants and individuals with systemic illness are not included in the study.

The study procedure is explained to the participants and the consent forms are obtained study participants.

Indian version of VFS-A is given to each subject to evaluate the listening related fatigue and the participants are instructed regarding the self-administration of the questionnaire. The VFS-A has 4 domains which includes Cognition, Emotion, Social and Physical. There are 2 sets of questions. For each item in the first set of questions, the subject has to select any single response from 0 being Never/ Almost never to 4 being Almost Always/Always. For each item in the

second set of questions, the subject has to select any single response from 0 being Strongly disagree to 4 being strongly agree.

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

  • People exposed to noise at work (85dBA or higher for 8 hours per day) Individual who can read and understand Kannada.

排除标准

  • Individuals with systemic illness.
  • Individuals under medication and treatments like chemo, radiation, painkillers, heart medications, and antidepressants.

结局指标

主要结局

Sum of all subscale scores of different domains of Vanderbuilt Fatigue Scale. The results offer a

时间窗: one time testing

qualitative assessment of listening-related fatigue. More listening-related fatigue is reflected in

时间窗: one time testing

higher summed values.

时间窗: one time testing

次要结局

  • There is no secondary outcome. There is only one outcome which has been mentioned in primary outcome slot.(Nil)

研究者

发起方
Jilsha M
申办方类型
Other [Self Funding]
责任方
Principal Investigator
主要研究者

Jilsha M

Manipal College of Health Professions

研究点 (1)

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