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Preventing Noise Exposure in Farmworkers

Preventing Noise Exposure in Farmworkers

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07271290
Acronym
POP
Enrollment
15
Registered
2025-12-09
Start date
2026-10-01
Completion date
2031-01-01
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noise Exposure

Keywords

noise exposure, hearing loss, farmworker

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.

Interventions

BEHAVIORALFarmworker 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.

Sponsors

San Diego State University
Lead SponsorOTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in Earplug Fit (Personal Attenuation Rating)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

MeasureTime frameDescription
Change in Hearing Protection Beliefs and AttitudesPre-training and immediately post-trainingChange in self-reported beliefs and attitudes toward hearing protection use, assessed using the 14-item Hearing Protection Beliefs scale. Items are rated on a 4-point Likert scale (1 = disagree to 4 = strongly agree) and summed after reverse-coding negatively worded items. Total scores range from 14 to 56, with higher scores indicating more favorable and accurate beliefs about hearing protection.
Acceptability of the Hearing Protection TrainingImmediately post-trainingParticipant-reported acceptability of the training assessed immediately post-training using the Acceptability of Intervention Measure (AIM). The AIM consists of 4 items rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Item responses are averaged to generate a mean score ranging from 1 to 5, with higher scores indicating greater perceived acceptability of the training.
Feasibility of the Hearing Protection TrainingImmediately post-trainingParticipant-reported feasibility of the training assessed immediately post-training using the Feasibility of Intervention Measure (FIM). The FIM consists of 4 items rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Item responses are averaged to generate a mean score ranging from 1 to 5, with higher scores indicating greater perceived feasibility of the training.
Appropriateness of the Hearing Protection TrainingImmediately post-trainingParticipant-reported appropriateness of the training assessed immediately post-training using the Intervention Appropriateness Measure (IAM). The IAM consists of 4 items rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Item responses are averaged to generate a mean score ranging from 1 to 5, with higher scores indicating greater perceived appropriateness of the training.

Contacts

CONTACTLaura Coco, PhD, AuD
lcoco@sdsu.edu16195943151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026