| CTRI Number |
CTRI/2024/01/061741 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on tiredness from listening in individuals exposed to workplace noise in industrial setting |
|
Scientific Title of Study
|
Exploratory study on listening related fatigue in individuals exposed to occupational noise in industrial setting |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jilsha M |
| Designation |
PG student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of speech and hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09048608353 |
| Fax |
|
| Email |
jilshamohammedali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms. Bhargavi |
| Designation |
Assisstant Professor |
| 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 |
|
Details of Contact Person
Public Query
|
| Name |
Jilsha M |
| Designation |
PG student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of speech and hearing, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09048608353 |
| Fax |
|
| Email |
jilshamohammedali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College of Manipal |
|
|
Primary Sponsor
|
| Name |
Jilsha M |
| Address |
Department of speech and hearing, Manipal College of Health Professions, MAHE, Manipal |
| Type of Sponsor |
Other [Self Funding] |
|
|
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 Hari Prakash |
Manipal college of health professions |
Preclinicals room, room no. 76, department of speech and hearing, manipal college of health professions, MAHE, Manipal
Udupi
KARNATAKA |
9886135522
hari.prakash@manipa.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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals exposed to occupational noise
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
People exposed to noise at work (85dBA or higher for 8 hours per day)
Individual who can read and understand Kannada |
|
| ExclusionCriteria |
| Details |
Individuals with systemic illness.
Individuals under medication and treatments like chemo, radiation, painkillers, heart
medications, and antidepressants. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Sum of all subscale scores of different domains of Vanderbuilt Fatigue Scale. The results offer a
qualitative assessment of listening-related fatigue. More listening-related fatigue is reflected in
higher summed values. |
one time testing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is no secondary outcome. There is only one outcome which has been mentioned in primary outcome slot. |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
26/01/2024 |
| 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 Yet Recruiting |
| 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
|
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. |