Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001204831
Ethics application status
Approved
Date submitted
21/10/2012
Date registered
15/11/2012
Date last updated
15/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The study is going to determine whether the noise attenuation attained with the use of earplugs can be improved by teaching the proper insertion of earplugs to users and comparison of the effect of this training with using an ear plug with higher than needed NRR (Noise reduction rate).
Scientific title
Effect of training on the improvement of the efficacy of earplugs compared to using a higher than necessary NRR (Noise reduction rate) in high-noise environment workers referred to the clinic for pre-employment evaluation.
Secondary ID [1] 281417 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Noise-induced hearing loss 287666 0
Condition category
Condition code
Ear 288006 288006 0 0
Normal ear development and function
Public Health 288032 288032 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
training the proper use of earplugs
(one-on-one training by occupational medicine resident will be done on the use and insertion of earplugs, once a time which will take for 5 minute)

and

earplug with higher than necessary NRR

(in our study audiometry is not intervention, we will evaluate the effect of interventions by audiometry.)

(audiometry is done at 500, 1000, 2000, 3000, 4000, 6000, and 8000 Hz, with interruption period of 0.5 s by an audiometer AC40 and headphones TDH39. Noise attenuation will be determined by the REAT(Real ear at threshold) method in a noisy (98db) chamber, once only which will take for 1 minute.)
Intervention code [1] 285910 0
Prevention
Comparator / control treatment
this group only evaluated for how to used earplug without any intervention by audiometry
Control group
Active

Outcomes
Primary outcome [1] 288216 0
Evaluate the effect of Training in increasing of earplug efficiency in comparison with control group.

(this outcome will be assessed by determined audiometric threshold before and after intervention)
Timepoint [1] 288216 0
immediately after training
Primary outcome [2] 288217 0
comparison the effect of using a higher than needed earplug (NRR) with control group in noise attenuation

(this outcome will be assessed by determined audiometric threshold before and after intervention)
Timepoint [2] 288217 0
immediately after intervention
Secondary outcome [1] 299624 0
nill
Timepoint [1] 299624 0
nill

Eligibility
Key inclusion criteria
All workers referred to the clinic for pre-employment evaluation
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
men who used earplugs in noisy places previously

who have conductive or sensorineural hearing loss in base audiometry

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 4615 0
Iran, Islamic Republic Of
State/province [1] 4615 0

Funding & Sponsors
Funding source category [1] 286182 0
University
Name [1] 286182 0
shahid sadoughi university of medical science
Country [1] 286182 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
shahid sadoughi university of medical science
Address
shahid sadoughi university of medical science, bahonar avu, Yazd, Iran.postcode: 8913893111
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 284992 0
None
Name [1] 284992 0
nill
Address [1] 284992 0
nill
Country [1] 284992 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34853 0
Address 34853 0
Country 34853 0
Phone 34853 0
Fax 34853 0
Email 34853 0
Contact person for public queries
Name 18100 0
mojahede salmani
Address 18100 0
occupational medicine department, farokhi avu, Yazd,Iran.postcode: 8913893111
Country 18100 0
Iran, Islamic Republic Of
Phone 18100 0
00983516229192
Fax 18100 0
Email 18100 0
[email protected]
Contact person for scientific queries
Name 9028 0
mojahede salmani
Address 9028 0
occupational medicine department, farokhi avu, Yazd,Iran.postcode: 8913893111
Country 9028 0
Iran, Islamic Republic Of
Phone 9028 0
00983516229192
Fax 9028 0
Email 9028 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.