Noise ExposurePOPNCT07271290
Preventing Noise Exposure in Farmworkers
A study testing Farmworker Hearing Protection Training in people with Noise Exposure, run by San Diego State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Noise Exposure
- What is being tested?
- Farmworker Hearing Protection Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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
- Being tested
- Farmworker Hearing Protection Training
- Keywords
- noise exposure, hearing loss, farmworker
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Farmworker Hearing Protection TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Farmworker Hearing Protection Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-training and immediately post-training (single session)
Secondary outcomes (4)
Change in Hearing Protection Beliefs and Attitudes
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.
Measured: Pre-training and immediately post-training
Acceptability of the Hearing Protection 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.
Measured: Immediately post-training
Feasibility of the Hearing Protection 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.
Measured: Immediately post-training
Appropriateness of the Hearing Protection 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.
Measured: Immediately post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Noise ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Laura Coco, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271290
- Sponsor's protocol ID
- IRB-25-0158
- Other IDs
- 1K23DC022303-01A1
- Acronym
- POP
- Status last verified
- Feb 2026
- First submitted
- 27 Nov 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Coco L, Finlayson TL, Lopez-Galvez N, Ruedas P, L Rosiles A, Toji Ruiz B, Angel B, Torres E, Zuniga ML. Hearing Loss Prevention Training for Spanish-Speaking Farmworkers: Protocol for a Community-Engaged Hybrid Type 1 Pilot Study. JMIR Res Protoc. 2026 Oct 5;15:e93134. doi: 10.2196/93134.
PubMed 42832761
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Noise Exposure in Farmworkers
- ClinicalTrials.gov ID
- NCT07271290
- Acronym / sponsor ID
- POP / IRB-25-0158
- Conditions
- Noise Exposure
- Keywords
- noise exposure, hearing loss, farmworker
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Farmworker Hearing Protection Training | Experimental | Behavioral: Farmworker Hearing Protection TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Farmworker Hearing Protection TrainingThis 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. | Behavioural | Experimental: Farmworker Hearing Protection Training |
Primary outcome
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.
4 secondary outcomes
Change in Hearing Protection Beliefs and Attitudes
Time frame: Pre-training and immediately post-training
Acceptability of the Hearing Protection Training
Time frame: Immediately post-training
Feasibility of the Hearing Protection Training
Time frame: Immediately post-training
Appropriateness of the Hearing Protection Training
Time frame: Immediately post-training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 42832761Coco L, Finlayson TL, Lopez-Galvez N, Ruedas P, L Rosiles A, Toji Ruiz B, Angel B, Torres E, Zuniga ML. Hearing Loss Prevention Training for Spanish-Speaking Farmworkers: Protocol for a Community-Engaged Hybrid Type 1 Pilot Study. JMIR Res Protoc. 2026 Oct 5;15:e93134. doi: 10.2196/93134.
- Individual participant dataSharing planned: Undecided
Related trials for Noise Exposure
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
RecruitingObservational study
Effect of Operating Room Noise on BIS and Hemodynamics Under General Anesthesia
General Anesthesia, Hemodynamics
Not yet recruitingObservational study
OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
Occupational Noise Exposure
Enrolling by invitation
Comparative Efficacy of Earplug Usage Instruction
Noise-Induced Hearing Loss, Hearing Protection Device Use
Active, not recruitingObservational study
Federal Aviation Administration (FAA) National Sleep Study
Noise Exposure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Farmworker Hearing Protection Training in people with Noise Exposure, run by San Diego State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Coco, PhD, AuD (16195943151, lcoco@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Earplug Fit (Personal Attenuation Rating) (time frame: Pre-training and immediately post-training (single session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07271290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.