Comparative Efficacy of Earplug Usage Instruction

Официальное название

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

Обзор

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

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• 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) . [Срок оценки: before the instruction , Immediately after the instruction and at 1 weeks post-intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Таиланд · 1 центр

• Department of Otolaryngology Faculty of Medicine, Chiang Mai University — Chiang Mai

Публикации

• 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
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• 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

Идентификаторы

NCT: NCT07731321 · ENT-2568-0432

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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