NCT Number: NCT07271290
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Pre-training and immediately post-training
Change 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.
Time frame: Immediately post-training
Participant-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.
Time frame: Immediately post-training
Participant-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.
Time frame: Immediately post-training
Participant-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.
Contact information is provided by the study sponsor or research team.
San Diego State University
Other
Acronym: POP
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