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西班牙语农场工人的听力损失预防培训:社区参与混合1型试点研究方案

Hearing Loss Prevention Training for Spanish-Speaking Farmworkers: Protocol for a Community-Engaged Hybrid Type 1 Pilot Study.

临床研究耳科IF 1.6Q3

文献信息

中文摘要

背景: 噪声性听力损失是永久性的,但可以预防。农业工人经常经历危险噪声暴露,而听力保护使用率仍然很低。现有干预措施强调个人知识和意图,很少使用客观结果指标进行测试。本方案描述了针对农场工人的多水平噪声性听力损失预防干预中个体水平组成部分的适应和试点评估。本试点侧重于完善和测试一个简短的数字化传递的中篇小说。
目的: 本研究的目标是(1)使用社区参与式研究方法,为美国西南部的农场工人文化和语言适应一个数字化传递的西班牙语娱乐教育听力保护培训(带有引导讨论和指导耳塞佩戴的数字中篇小说);以及(2)试点测试适应后的干预措施,以评估可接受性、可行性和适当性,并估计客观听力保护器贴合度变化的初步效应量。
方法: 这是一项单臂、前后测、混合1型有效性-实施试点研究。第1阶段包括对农场工人和农场主管(n=30)的形成性访谈,以实施研究综合框架为指导,以指导培训内容和传递的适应。第2阶段涉及向未参与形成性工作的农场工人(n=15)提供单次培训。主要探索性结果是个人衰减评级的前后变化,这是听力保护器贴合度的客观测量。次要结果包括听力保护信念的变化和实施结果(可接受性、可行性和适当性)。
结果: 本研究于2025年7月获得资助,并于2025年12月在ClinicalTrials.gov注册(NCT07271290)。第1阶段招募于2025年7月开始,数据收集于2026年1月结束,共招募30名参与者。第2阶段试点招募于2026年7月开始,截至2026年7月已招募1名参与者。第2阶段数据收集预计于2027年春季结束。数据分析将在数据收集完成后进行,研究结果预计于2028年发表。
结论: 本方案描述了针对农场工人的文化定制、数字化传递的听力保护微培训的社区参与适应和试点评估。通过将客观贴合度测试与实用的实施措施和系统适应跟踪相结合,该研究将评估可行性并估计初步效应量,为后续整合主管和组织组成部分的多水平试验提供信息。

英文摘要

BACKGROUND: Noise-induced hearing loss is permanent yet preventable. Agricultural workers routinely experience hazardous noise exposure, and hearing protection use remains low. Existing interventions emphasize individual knowledge and intentions and have rarely been tested using objective outcome measures. This protocol describes the adaptation and pilot evaluation of an individual-level component of a multilevel noise-induced hearing loss prevention intervention for farmworkers. This pilot focuses on refining and testing a brief digitally delivered novella.
OBJECTIVE: The objectives of this study are to (1) culturally and linguistically adapt a digitally delivered, Spanish-language entertainment-education hearing protection training (digital novella with facilitated discussion and coached earplug fitting) for farmworkers in the Southwest United States, using community-based participatory research; and (2) pilot test the adapted intervention to assess acceptability, feasibility, and appropriateness and to estimate preliminary effect sizes for changes in objective hearing protector fit.
METHODS: This is a single-arm, pre-post, Hybrid Type 1 effectiveness-implementation pilot study. Phase 1 includes formative interviews with farmworkers and farm supervisors (n=30), informed by the Consolidated Framework for Implementation Research, to guide adaptation of training content and delivery. Phase 2 involves a single training session delivered to farmworkers not involved in the formative work (n=15). The primary exploratory outcome is pre-post change in the Personal Attenuation Rating, an objective measure of hearing protector fit. Secondary outcomes include changes in hearing protection beliefs and implementation outcomes (acceptability, feasibility, and appropriateness).
RESULTS: Funding for this study was obtained in July 2025, and the study was registered on ClinicalTrials.gov in December 2025 (NCT07271290). Phase 1 recruitment began in July 2025, and data collection concluded in January 2026, with 30 participants enrolled. Phase 2 pilot recruitment began in July 2026, and 1 participant had been enrolled as of July 2026. Phase 2 data collection is expected to conclude in Spring 2027. Data analysis will follow completion of data collection, and study findings are expected to be published in 2028.
CONCLUSIONS: This protocol describes a community-engaged adaptation and pilot evaluation of a culturally tailored, digitally delivered hearing protection microtraining for farmworkers. By pairing objective fit testing with pragmatic implementation measures and systematic adaptation tracking, the study will assess feasibility and estimate preliminary effect sizes to inform a subsequent multilevel trial that integrates supervisor and organizational components.