A Randomized Controlled Trial Comparing Smartphone-Based and Face-to-Face Counseling for Chronic Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Tinnitus Impact
研究概览
简要总结
This study aims to compare the effectiveness of smartphone-based counseling and face-to-face counseling in adults with chronic tinnitus. Both interventions are based on the same structured counseling protocol and are delivered over a six-week period. The primary research question is whether smartphone-based counseling can achieve clinical outcomes comparable to those of traditional face-to-face counseling in reducing tinnitus-related impact and associated symptoms.
详细描述
This study is a randomized, parallel-group clinical trial designed to evaluate two counseling delivery formats for chronic tinnitus. Eligible adult participants with chronic subjective tinnitus are allocated to either smartphone-based counseling or face-to-face counseling. Both groups receive the same structured counseling content, with the delivery format being the only difference between interventions.
The counseling protocol focuses on tinnitus education, correction of maladaptive beliefs, and development of coping strategies. In the face-to-face group, counseling is delivered through scheduled in-person sessions using a structured educational booklet. In the smartphone-based group, the same content is delivered through a mobile application consisting of sequential modules, including assessment, education, coping strategies, and a clinician support feature.
Participants in both groups complete baseline assessments prior to counseling and follow-up evaluations at two and six weeks. The study is designed to examine whether smartphone-based counseling can achieve outcomes comparable to traditional face-to-face counseling when a unified counseling protocol is applied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Diagnosis of chronic subjective tinnitus lasting at least 6 months
- •Completion of a comprehensive audiological evaluation
- •Ability to read and understand the study materials
- •Adequate cognitive function as determined by a Mini-Mental State Examination score of 25 or higher
- •Willingness and ability to provide written informed consent
排除标准
- •Presence of objective tinnitus
- •History of neurological disorders
- •Diagnosed major psychiatric disorders
- •Receipt of tinnitus-related treatment within the previous 3 months
- •Inability to use or access the smartphone application (for technical or device-related reasons)
研究组 & 干预措施
Face-to-Face Counseling
Participants receive structured tinnitus counseling delivered in person using a standardized educational booklet over a six-week period.
干预措施: Face-to-Face Tinnitus Counseling (Behavioral)
Smartphone-Based Counseling
Participants receive the same structured tinnitus counseling delivered via a mobile application with sequential modules over a six-week period.
干预措施: Smartphone-Based Tinnitus Counseling (Behavioral)
结局指标
主要结局
Tinnitus Impact
时间窗: Baseline to 6 weeks
Change in tinnitus impact assessed using the Tinnitus Handicap Inventory (THI).
次要结局
- Depressive Symptoms(Baseline to 6 weeks)
- Sleep Quality(Baseline to 6 weeks)
- Perceived Tinnitus Severity(Baseline to 6 weeks)
- Tinnitus-Related Annoyance(Baseline to 6 weeks)
研究者
Beyza ASTA
Research Assistant
TC Erciyes University