Comparative Efficacy of Earplug Usage Instruction

NCT07731321 | Enrolling By Invitation

• 1 other identifier: ENT-2568-0432
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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

Conditions

Noise-Induced Hearing Loss; Hearing Protection Device Use; Noise-exposed Hospital Personnel

Keywords

Ear Plugs; Noise-induced Hearing loss; Video-Based Instruction; Paper-Based Instruction; Instruction Method; Hearing Protection Device

Outcome Measures

Primary Outcomes (1)

• 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) .

  The primary outcome is earplug insertion skill, defined as the participant's ability to correctly perform earplug insertion. Skill will be assessed using the Standardized Foam Earplug Insertion Checklist (SFEIC) , a standardized 20-point observational checklist (10 points per ear), covering key steps such as hand hygiene, earplug preparation, insertion technique, and fit verification. Each item is scored as correct (1 point) or incorrect (0 points), for a total score ranging from 0 (minimum) to 20 (maximum). Higher scores indicate better (more correct) earplug insertion technique. Participants will be asked to demonstrate earplug insertion, and performance will be evaluated by trained assessors blinded to group allocation.

  before the instruction , Immediately after the instruction and at 1 weeks post-intervention

Study Arms (2)

Arm 1 : Video-Based Earplug Instruction

EXPERIMENTAL

Arm 1 * Arm Label: Video-based instruction * Arm Type: Experimental * Arm Description: Participants receive a 3-minute narrated video demonstrating proper earplug insertion technique, followed by practice and assessment.

Behavioral: Video-Based Earplug Instruction

Arm 2 : Paper-Based Earplug Instruction

ACTIVE COMPARATOR

Arm 2 * Arm Label: Paper-based instruction * Arm Type: Active Comparator * Arm Description: Participants receive a paper-based illustrated infographic with written instructions covering identical content to the video, followed by practice and assessment.

Behavioral: Paper-Based Earplug Instruction

Interventions

Video-Based Earplug Instruction BEHAVIORAL

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.

Arm 1 : Video-Based Earplug Instruction

Paper-Based Earplug Instruction BEHAVIORAL

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.

Arm 2 : Paper-Based Earplug Instruction

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sirinthorn Chanaveroj: lead
• Chiang Mai University: collaborator

Study Sites (1)

Department of Otolaryngology Faculty of Medicine, Chiang Mai University

Chiang Mai, 50200, Thailand

Location

Related Publications (15)

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Gong W, Murphy WJ, Meinke DK, Feng HA, Stephenson MR. Evaluating Earplug Performance over a 2-Hour Work Period with a Fit-Test System. Semin Hear. 2023 Jun 1;44(4):470-484. doi: 10.1055/s-0043-1769586. eCollection 2023 Nov.

  PMID: 37818150 BACKGROUND

• Daniel E. Noise and hearing loss: a review. J Sch Health. 2007 May;77(5):225-31. doi: 10.1111/j.1746-1561.2007.00197.x.

  PMID: 17430434 BACKGROUND

• Chow, S.-C., Shao, J., & Wang, H. (2003). Sample Size Calculations in Clinical Research (2nd ed.). Chapman & Hall/CRC., p. 51.

  BACKGROUND

• Centers for Disease Control and Prevention [Internet]. Washington, DC: DHHS, CDC. [updated 2024; cited 2025]. Noise and hearing loss prevention; [about 1 screen]. Available from www.cdc.gov/niosh/topics/noise/about.html (Accessed 29 January 2025).

  BACKGROUND

• Brueck, E. (n.d.).Hearing protection. OSHwiki. Retrieved January 29, 2025, from https://oshwiki.osha.europa.eu/en/themes/hearing-protection

  BACKGROUND

• 2. Berger, E. H. (2000). Hearing protection devices. In E. H. Berger, L. H. Royster, J. D. Royster, D. P. Driscoll, & M. Layne (Eds.), The Noise Manual (5th ed.). Fairfax, VA: AIHA Press.

  BACKGROUND

• Basner M, Babisch W, Davis A, Brink M, Clark C, Janssen S, Stansfeld S. Auditory and non-auditory effects of noise on health. Lancet. 2014 Apr 12;383(9925):1325-1332. doi: 10.1016/S0140-6736(13)61613-X. Epub 2013 Oct 30.

  PMID: 24183105 BACKGROUND

Related Links

• EU-OSHA : Hearing protection
• Hearing protection use in recreational music exposure: A review and analysis of the literature.
• NIH : Noise-Induced Hearing Loss
• WHO, 2015.Make Listening Safe. World Health Organization; 2015

MeSH Terms

Conditions

Hearing Loss, Noise-Induced

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• sirinthorn chanaveroj

  Department of Otolaryngology , Faculty of medicine Chiang Mai university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors administering the skill assessment checklist and the data analysts are blinded to group allocation. Due to the nature of the intervention, participants themselves cannot be blinded to which training format (video vs. paper) they receive.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident, Department of Otolaryngology, Faculty of Medicine, Chiang Mai University

Model Details: This is a parallel-group, randomized controlled trial. Eligible participants are randomly assigned in a 1:1 ratio to receive either video-based or paper-based instruction on proper earplug insertion technique, using computer-generated randomization (block size of 4) with allocation concealment via sealed opaque envelopes. Both instructional formats deliver identical educational content, differing only in mode of delivery. Each participant receives only one type of instruction (no crossover), and outcome assessors and data analysts are blinded to group allocation.

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 28, 2026
• Study Start: June 8, 2026
• Primary Completion: June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)