Comparative Efficacy of Earplug Usage Instruction (CEEUIn)
24. juli 2026 oppdatert av: 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:
- 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?
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
Studieoversikt
Status
Påmelding etter invitasjon
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
64
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Chiang Mai, Thailand, 50200
- Department of Otolaryngology Faculty of Medicine, Chiang Mai University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Arm 1 : Video-Based Earplug Instruction
Arm 1
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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.
|
|
Aktiv komparator: Arm 2 : Paper-Based Earplug Instruction
Arm 2
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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) .
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: sirinthorn chanaveroj, Department of Otolaryngology , Faculty of medicine Chiang Mai university
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- Sliwinska-Kowalska M, Davis A. Noise-induced hearing loss. Noise Health. 2012 Nov-Dec;14(61):274-80. doi: 10.4103/1463-1741.104893.
- 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.
- 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.
- 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.
- 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.
- Chow, 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. juni 2026
Primær fullføring (Faktiske)
30. juni 2026
Studiet fullført (Antatt)
31. august 2026
Datoer for studieregistrering
Først innsendt
11. juli 2026
Først innsendt som oppfylte QC-kriteriene
24. juli 2026
Først lagt ut (Faktiske)
28. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ENT-2568-0432
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared to protect patient privacy and confidentiality in accordance with the institutional review board approval.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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