Preventing Noise Exposure in Farmworkers

NCT07271290 | Not Yet Recruiting DMC

• 2 other identifiers: IRB-25-01581K23DC022303-01A1
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate a farmworker-level hearing loss prevention training designed to improve hearing protection use among farmworkers exposed to hazardous occupational noise. The intervention consists of a culturally and linguistically adapted, Spanish-language digital training module paired with hands-on earplug fitting and coaching. The primary goals of the study are to (1) assess the feasibility and acceptability of delivering the adapted training in community-based settings, and (2) estimate preliminary effectiveness using an objective measure of hearing protection fit. The study uses a single-arm, pre-post pilot design. A small group of farmworkers will complete pre- and post-training assessments of earplug fit, as well as brief surveys assessing hearing protection knowledge, attitudes, and perceptions. Qualitative feedback will be collected to inform refinement of the training and guide future scale-up. Results will inform the development of a subsequent multilevel intervention that integrates supervisor and organizational components.

Conditions

Noise Exposure

Keywords

noise exposure; hearing loss; farmworker

Outcome Measures

Primary Outcomes (1)

• Change in Earplug Fit (Personal Attenuation Rating)

  Change in hearing protection fit measured using the Personal Attenuation Rating (PAR), an objective, device-generated fit-testing metric expressed in decibels (dB). PAR quantifies the level of noise attenuation achieved by an individual's foam earplug insertion. PAR values are obtained using standardized hearing protector fit-testing procedures conducted immediately before and immediately after the training session. PAR scores are reported in dB and typically range from 0 dB (no attenuation) to approximately 40 dB or greater depending on fit and device characteristics. Higher PAR values indicate greater attenuation and better earplug fit.

  Pre-training and immediately post-training (single session)

Secondary Outcomes (4)

• Change in Hearing Protection Beliefs and Attitudes

  Pre-training and immediately post-training

• Acceptability of the Hearing Protection Training

  Immediately post-training

• Feasibility of the Hearing Protection Training

  Immediately post-training

• Appropriateness of the Hearing Protection Training

  Immediately post-training

Study Arms (1)

Experimental: Farmworker Hearing Protection Training

EXPERIMENTAL

Participants in this single-arm pilot study receive a one-time, farmworker-level hearing protection training. The intervention consists of a culturally and linguistically adapted Spanish-language digital training module paired with facilitated discussion and hands-on coaching in proper foam earplug insertion. All participants complete pre- and post-training assessments; there is no comparison or control group.

Behavioral: Farmworker Hearing Protection Training

Interventions

Farmworker Hearing Protection Training BEHAVIORAL

This behavioral intervention is a brief, farmworker-level hearing protection training. The intervention includes a culturally adapted digital training module (novella-style) focused on noise-induced hearing loss prevention and correct foam earplug use, combined with hands-on earplug fitting and teach-back coaching. The training is delivered in a single session in a community-based setting.

Experimental: Farmworker Hearing Protection Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Currently employed as a farmworker in agricultural settings with routine exposure to occupational noise
• Able to understand and provide informed consent in Spanish or English

You may not qualify if:

• Not currently employed as a farmworker
• Medical or ear conditions that preclude safe use of foam earplugs (e.g., acute ear infection, recent ear surgery)
• Inability to complete study procedures as determined by study staff

Sponsors & Collaborators

• San Diego State University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Laura Coco, PhD, AuD

CONTACT

16195943151; lcoco@sdsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a single-arm, pre-post pilot study in which all participants receive the same hearing protection training intervention. Outcomes are assessed immediately before and after a single training session to estimate feasibility, acceptability, and preliminary effectiveness.

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: February 17, 2026

Record last verified: 2026-02