Comparative Efficacy of Earplug Usage Instruction (CEEUIn)

July 24, 2026 updated by: Sirinthorn Chanaveroj

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Chiang Mai, Thailand, 50200
        • Department of Otolaryngology Faculty of Medicine, Chiang Mai University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 : Video-Based Earplug Instruction

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
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.
Active Comparator: Arm 2 : Paper-Based Earplug Instruction

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before the instruction , Immediately after the instruction and at 1 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sirinthorn Chanaveroj

Collaborators

Chiang Mai University

Investigators

  • Principal Investigator: sirinthorn chanaveroj, Department of Otolaryngology , Faculty of medicine Chiang Mai university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2026

Primary Completion (Actual)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

July 11, 2026

First Submitted That Met QC Criteria

July 24, 2026

First Posted (Actual)

July 28, 2026

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENT-2568-0432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect patient privacy and confidentiality in accordance with the institutional review board approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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