Erciyes University Faculty of Health Sciences
Kayseri, 38000, Turkey (Türkiye)
NCT Number: NCT07324603
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Kayseri, 38000, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
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)
Structured tinnitus counseling is delivered in person using a standardized educational booklet over a six-week period.
Structured tinnitus counseling is delivered via a mobile application with sequential modules over a six-week period
Time frame: Baseline to 6 weeks
Change in tinnitus impact assessed using the Tinnitus Handicap Inventory (THI).
Time frame: Baseline to 6 weeks
Change in depressive symptoms assessed using the Beck Depression Inventory (BDI).
Time frame: Baseline to 6 weeks
Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).
Time frame: Baseline to 6 weeks
Change in perceived tinnitus severity assessed using a Visual Analog Scale (VAS).
Time frame: Baseline to 6 weeks
Change in tinnitus-related annoyance assessed using a Visual Analog Scale (VAS).
TC Erciyes University
Other
A Randomized Controlled Trial Comparing Smartphone-Based and Face-to-Face Counseling for Chronic Tinnitus
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