Preventing Noise Exposure in Farmworkers

NCT ID: NCT07271290

Last Updated: 2026-02-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-10-01
• Study Completion Date: 2031-01-01

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.

Detailed Description

Noise-induced hearing loss (NIHL) is a permanent occupational condition resulting from cumulative exposure to hazardous noise. Farmworkers are routinely exposed to high noise levels from agricultural equipment, yet hearing protection use remains low, particularly among Spanish-speaking workers. Prior hearing conservation efforts in agriculture have emphasized self-reported behaviors and have rarely incorporated objective outcome measures or culturally and linguistically adapted training approaches.

This study evaluates a farmworker-level hearing protection micro-training as part of a community-engaged pilot designed to inform subsequent multilevel intervention development. The study uses a single-arm, pre-post design and focuses on feasibility, acceptability, and preliminary effectiveness of the adapted training.

The intervention consists of a Spanish-language digital training module adapted through formative research with farmworkers and delivered with facilitated discussion and hands-on coaching in proper foam earplug insertion. Adaptations are informed by community input and documented using implementation science frameworks to support transparency and reproducibility.

Participants complete baseline assessments followed by a single training session and immediate post-training assessments. The primary effectiveness endpoint is an objective measure of hearing protection fit obtained through standardized fit-testing procedures. Additional measures assess short-term changes in hearing protection beliefs and implementation-related outcomes to characterize feasibility and acceptability of delivery in community-based settings.

This pilot is not designed to evaluate changes in long-term behavior or occupational noise exposure. Rather, results will be used to refine intervention content and delivery procedures, estimate preliminary effect sizes, and inform the design of a future cluster-randomized trial that incorporates supervisor and organizational-level components for hearing loss prevention in agricultural settings.

Conditions

Noise Exposure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental: Farmworker Hearing Protection Training

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.

Group Type: EXPERIMENTAL

Farmworker Hearing Protection Training

Intervention Type: 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.

Interventions

Farmworker Hearing Protection Training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

San Diego State University

OTHER

Sponsor Role: lead

Responsible Party

Laura Coco

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Laura Coco, PhD, AuD

Role: CONTACT

lcoco@sdsu.edu

16195943151

Other Identifiers

1K23DC022303-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-25-0158

Identifier Type: -

Identifier Source: org_study_id