Noise-Induced Hearing LossCEEUInNCT07731321
Comparative Efficacy of Earplug Usage Instruction
A study testing Video-Based Earplug Instruction and Paper-Based Earplug Instruction in people with Noise-Induced Hearing Loss and Hearing Protection Device Use, run by Sirinthorn Chanaveroj at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Noise-Induced Hearing Loss, Hearing Protection Device Use, Noise-exposed Hospital Personnel
- What is being tested?
- Video-Based Earplug Instruction and Paper-Based Earplug Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- 8 Jun 2026to 31 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Department of Otolaryngology Faculty of Medicine, Chiang Mai University
Chiang Mai, 50200
About this study
Official title: 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:
- Which training method ,between video-based and paper-based instruction, produces better earplug insertion skill immediately after training?
- Is any improvement in earplug insertion skill sustained at 1-week follow-up?
Read more
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
- Conditions
- Noise-Induced Hearing Loss, Hearing Protection Device Use, Noise-exposed Hospital Personnel
- Being tested
- Video-Based Earplug Instruction, Paper-Based Earplug Instruction
- Keywords
- Ear Plugs, Noise-induced Hearing loss, Video-Based Instruction, Paper-Based Instruction, Instruction Method, Hearing Protection Device
- Medical subject headings
- Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Based Earplug InstructionBehavioural
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 InstructionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Paper-Based Earplug Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before the instruction , Immediately after the instruction and at 1 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start8 Jun 2026
- Primary completion30 Jun 2026
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Noise-Induced Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sirinthorn Chanaveroj
- Sponsor type
- University, hospital or other
- Collaborators
- Chiang Mai University
- Responsible party
- Sponsor-investigator, Sirinthorn Chanaveroj, Chiang Mai University
- Investigators
- sirinthorn chanaveroj, Principal investigator, Department of Otolaryngology , Faculty of medicine Chiang Mai university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731321
- Sponsor's protocol ID
- ENT-2568-0432
- Acronym
- CEEUIn
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient privacy and confidentiality in accordance with the institutional review board approval.
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.
PubMed 18716388Takada 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.
PubMed 32007983Sliwinska-Kowalska M, Davis A. Noise-induced hearing loss. Noise Health. 2012 Nov-Dec;14(61):274-80. doi: 10.4103/1463-1741.104893.
PubMed 23257577Shukla 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.
PubMed 32151193Salmani 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.
PubMed 25270008Murphy 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.
PubMed 21368438Liberman 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.
PubMed 28690836Gong 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.
PubMed 37818150Daniel 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.
PubMed 17430434Chow, S.-C., Shao, J., & Wang, H. (2003). Sample Size Calculations in Clinical Research (2nd ed.). Chapman & Hall/CRC., p. 51.
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).
Brueck, E. (n.d.).Hearing protection. OSHwiki. Retrieved January 29, 2025, from https://oshwiki.osha.europa.eu/en/themes/hearing-protection
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.
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.
PubMed 24183105