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治験 NCT07271290 (POP)（対象：騒音曝露）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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Preventing Noise Exposure in Farmworkers (POP) 15 予防

募集準備中
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07271290 (POP) は 介入研究 臨床試験 で、騒音曝露 に関するものです。現在は 募集準備中 で、2026年10月1日 に開始予定です。15 名の参加者 の募集が計画されています。この試験は サンディエゴ州立大学 によって主導され、2031年1月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月17日 です。
概要
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 acceptabi...

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詳細説明
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 objec...もっと見る
公式タイトル

Preventing Noise Exposure in Farmworkers

疾患名
騒音曝露
その他の研究識別子
NCT番号
NCT07271290
開始日
2026-10-01
最終更新日
2026-02-17
終了予定日
2031-01-01
目標参加者数
15
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
noise exposure
hearing loss
farmworker
主目的
予防
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
実験的Experimental: Farmworker Hearing Protection Training
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.
Farmworker 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.
主要評価項目
評価指標指標の説明時間枠
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.
Pre-training and immediately post-training (single session)
副次評価項目
評価指標指標の説明時間枠
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.
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.
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.
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.
Immediately post-training
参加アシスタント
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
  • 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

  • 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
San Diego State University logoサンディエゴ州立大学
National Institute on Deafness and Other Communication Disorders (NIDCD) logoNational Institute on Deafness and Other Communication Disorders (NIDCD)
責任者
Laura Coco, 主任研究者, Assistant Professor, San Diego State University
試験中央連絡先
連絡先: Laura Coco, PhD, AuD, 16195943151, [email protected]
位置情報がありません。