Chronic Tinnitus
Conditions
Keywords
Chronic tinnitus, Counseling, Smartphone-based counseling, Digital Health, Mobile Application, Patient Education
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFace-to-Face Tinnitus Counseling
Structured tinnitus counseling is delivered in person using a standardized educational booklet over a six-week period.
BEHAVIORALSmartphone-Based Tinnitus Counseling
Structured tinnitus counseling is delivered via a mobile application with sequential modules over a six-week period
Sponsors
The Scientific and Technological Research Council of Turkey
TC Erciyes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Impact | Baseline to 6 weeks | Change in tinnitus impact assessed using the Tinnitus Handicap Inventory (THI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | Baseline to 6 weeks | Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). |
| Depressive Symptoms | Baseline to 6 weeks | Change in depressive symptoms assessed using the Beck Depression Inventory (BDI). |
| Perceived Tinnitus Severity | Baseline to 6 weeks | Change in perceived tinnitus severity assessed using a Visual Analog Scale (VAS). |
| Tinnitus-Related Annoyance | Baseline to 6 weeks | Change in tinnitus-related annoyance assessed using a Visual Analog Scale (VAS). |
Countries
Turkey (Türkiye)
Outcome results
None listed