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Clinical Trials/NCT07271290
NCT07271290Not yet recruitingNot Applicable

Preventing Noise Exposure in Farmworkers

San Diego State University0 sites15 target enrollmentStarted: October 1, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
15
Primary Endpoint
Change in Earplug Fit (Personal Attenuation Rating)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: Farmworker Hearing Protection Training (Behavioral)

Outcomes

Primary Outcomes

Change in Earplug Fit (Personal Attenuation Rating)

Time Frame: Pre-training and immediately post-training (single session)

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Laura Coco

Assistant Professor

San Diego State University

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Preventing Noise Exposure in Farmworkers | Clinical Trial