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Enrolling by invitation NCT07731321

Comparative Efficacy of Earplug Usage Instruction

No phase Interventional Noise-Induced Hearing Loss Hearing Protection Device Use Noise-exposed Hospital Personnel

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Video-Based Earplug Instruction, Paper-Based Earplug Instruction.
Who it may be relevant to
Registry conditions: Noise-Induced Hearing Loss, Hearing Protection Device Use, Noise-exposed Hospital Personnel. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparative Efficacy of Earplug Usage Instruction : A Randomized Trial of Video-Based And Paper-Based Instruction

Overview

The goal of this clinical trial is to learn whether video-based training or paper-based training is more effective at teaching correct earplug insertion technique, in hospital personnel at Maharaj Nakorn Chiang Mai Hospital who work in noise-exposed areas (e.g. laundry and kitchen units), aged 20-60 years. The main questions it aims to answer are: 1. Which training method ,between video-based and paper-based instruction, produces better earplug insertion skill immediately after training? 2. Is any improvement in earplug insertion skill sustained at 1-week follow-up? Researchers will compare a video-based instruction group to a paper-based instruction group to see if one training format leads to better and more lasting earplug insertion skill, as measured by a standardized 20-point observational checklist. Participants will: * Undergo a baseline history and ear exam (otoscopy) and complete a demographic questionnaire . * Have their baseline earplug insertion skill assessed by a blinded observer Be randomly assigned to receive either a 5-minute video-based or paper-based instruction on proper earplug use . * Practice inserting earplugs and then be reassessed immediately after training * Return after 1 week for a follow-up assessment to test retention of the skill

Interventions

  • Behavioral Video-Based Earplug Instruction
    A 3-minute narrated video demonstrating proper earplug insertion technique, covering hand hygiene, checking earplugs, proper rolling technique, ear canal opening, insertion method, adjustment, and verification of fit. Content is standardized and validated by content experts.
  • Behavioral Paper-Based Earplug Instruction
    An illustrated step-by-step infographic with brief written instructions covering identical content to the video-based module (hand hygiene, earplug preparation, insertion technique, and fit verification), reviewed and validated by content experts.

Primary outcome measures

  • The primary outcome is earplug insertion skill, defined as the participant's ability to correctly perform earplug insertion ,using the Standardized Foam Earplug Insertion Checklist (SFEIC) . [Time frame: before the instruction , Immediately after the instruction and at 1 weeks post-intervention]

Eligibility criteria

Inclusion criteria

  • Personnel aged 20-60 years old who report regular works in areas perceived as noisy department
  • Personnel who works at Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University, during the year 2026.
  • Personel who is willing and able to participate in the study throughout its duration.

Exclusion criteria

  • Individuals with active ear infections.
  • Individuals with ear canal stenosis that limit to insert the earplug.
  • Individuals with visual or auditory impairment that limit to read or see the instruction
  • Individuals who have limitation to use their hands to insert the ear plug.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Thailand · 1 center
  • Department of Otolaryngology Faculty of Medicine, Chiang Mai University — Chiang Mai

Publications

  • Yusoff MSB. ABC of content validation and content validity index calculation. Education in Medicine Journal. 2019;11(2):49-54. https://doi.org/10.21315/eimj2019.11.2.6
  • Tsukada T, Sakakibara H. A trail of individual education for hearing protection with an instrument that measures the noise attenuation effect of wearing earplugs. Ind Health. 2008 Aug;46(4):393-6. doi: 10.2486/indhealth.46.393. PMID 18716388
  • Takada MM, Rocha CH, Neves-Lobo IF, Moreira RR, Samelli AG. Training in the proper use of earplugs: An objective evaluation. Work. 2020;65(2):401-407. doi: 10.3233/WOR-203092. PMID 32007983
  • Sliwinska-Kowalska M, Davis A. Noise-induced hearing loss. Noise Health. 2012 Nov-Dec;14(61):274-80. doi: 10.4103/1463-1741.104893. PMID 23257577
  • Shukla A, Harper M, Pedersen E, Goman A, Suen JJ, Price C, Applebaum J, Hoyer M, Lin FR, Reed NS. Hearing Loss, Loneliness, and Social Isolation: A Systematic Review. Otolaryngol Head Neck Surg. 2020 May;162(5):622-633. doi: 10.1177/0194599820910377. Epub 2020 Mar 10. PMID 32151193
  • Salmani Nodoushan M, Mehrparvar AH, Torab Jahromi M, Safaei S, Mollasadeghi A. Training in using earplugs or using earplugs with a higher than necessary noise reduction rating? A randomized clinical trial. Int J Occup Environ Med. 2014 Oct;5(4):187-93. PMID 25270008
  • Murphy WJ, Stephenson MR, Byrne DC, Witt B, Duran J. Effects of training on hearing protector attenuation. Noise Health. 2011 Mar-Apr;13(51):132-41. doi: 10.4103/1463-1741.77215. PMID 21368438
  • Liberman MC. Noise-induced and age-related hearing loss: new perspectives and potential therapies. F1000Res. 2017 Jun 16;6:927. doi: 10.12688/f1000research.11310.1. eCollection 2017. PMID 28690836

Identifiers

NCT: NCT07731321 · ENT-2568-0432

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗