Sadali Mohamad Azmeer, Ishak Wan Syafira, Ahmad Mahadir, Hoare Derek J
Centre for Healthy Ageing & Wellness (H-CARE), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
Audiology Unit, Department of Otorhinolaryngology, Hospital Sungai Buloh, Ministry of Health, Selangor, Malaysia.
PLoS One. 2025 Jul 18;20(7):e0328348. doi: 10.1371/journal.pone.0328348. eCollection 2025.
Tinnitus, a phantom auditory perception, varies from mild awareness to intolerable sounds that can severely impact psychological well-being, sometimes leading to suicidal ideation. While its causality remains unclear, studies show a strong link between tinnitus severity and psychological distress. A manualized intervention developed in the United Kingdom for audiologists, using a low-intensity, psychologically informed approach, has been successfully trialed in Western populations. However, its feasibility in Asian settings, particularly in Malaysia with its diverse cultures, remains unknown.
Phase I involves three steps: (a) translating the intervention manual into Malay, (b) systematically adapting its content for cultural relevance, and (c) piloting the intervention. Phase II is a 4-month randomized controlled feasibility trial involving chronic tinnitus patients (n = 20), stratified by severity and randomly assigned to either (a) the adapted intervention delivered by a trained provider or (b) standard care. Feasibility outcomes include a 10% recruitment rate among eligible patients, a 65% eligibility rate within the target population, and 80% retention. Primary outcomes assess tinnitus severity via the Tinnitus Functional Index, while secondary outcomes measure psychological distress using the Depression Anxiety Stress Scale-42. Assessments occur at baseline, post-intervention (1 month), and at a 3-month follow-up. At follow-up, semi-structured interviews guided by the Theoretical Framework of Acceptability will explore participants' perceptions of the intervention.
This feasibility trial evaluates the practicality and acceptability of a culturally adapted, audiologist-delivered psychological intervention for chronic tinnitus patients in Malaysia. Unlike direct translations, it incorporates systematic cultural adaptation to ensure relevance for the target population. Findings will inform the viability of a future large-scale trial and the potential for expanding psychologically informed tinnitus care in audiology settings.
ACTRN12624001048572.
耳鸣是一种听觉幻觉，从轻微意识到难以忍受的声音不等，会严重影响心理健康，有时甚至导致自杀念头。虽然其病因尚不清楚，但研究表明耳鸣严重程度与心理困扰之间存在密切联系。英国为听力学家开发的一种手册化干预措施，采用低强度、心理导向的方法，已在西方人群中成功进行了试验。然而，其在亚洲环境中的可行性，特别是在文化多元的马来西亚，仍然未知。
第一阶段包括三个步骤：（a）将干预手册翻译成马来语，（b）系统地调整其内容以使其具有文化相关性，（c）对干预措施进行试点。第二阶段是一项为期4个月的随机对照可行性试验，涉及慢性耳鸣患者（n = 20），按严重程度分层并随机分配到以下两组之一：（a）由经过培训的提供者提供的适应性干预措施，或（b）标准护理。可行性结果包括符合条件的患者中10%的招募率、目标人群中65%的符合率以及80%的留存率。主要结果通过耳鸣功能指数评估耳鸣严重程度，次要结果使用抑郁焦虑压力量表-42测量心理困扰。评估在基线、干预后（1个月）和3个月随访时进行。在随访时，将以可接受性理论框架为指导进行半结构化访谈，以探索参与者对干预措施的看法。
这项可行性试验评估了一种针对马来西亚慢性耳鸣患者的、经过文化适应性调整的、由听力学家提供的心理干预措施的实用性和可接受性。与直接翻译不同，它纳入了系统的文化适应性调整，以确保与目标人群相关。研究结果将为未来大规模试验的可行性以及在听力环境中扩大心理导向的耳鸣护理的可能性提供信息。
ACTRN12624001048572。
