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Enrolling by Invitation

NCT Number: NCT07731321

Comparative Efficacy of Earplug Usage Instruction

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

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Otolaryngology Faculty of Medicine, Chiang Mai University

Chiang Mai, 50200, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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) .

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

    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.

Sponsors and collaborators

Lead sponsor

Sirinthorn Chanaveroj

Other

Collaborators

  • Chiang Mai University

Registry information

Official study title

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

Acronym: CEEUIn

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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