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| ID | Type | Description | Link |
|---|---|---|---|
| 124S118 | Other Grant/Funding Number | TUBITAK |
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| Name | Class |
|---|---|
| The Scientific and Technological Research Council of Turkey | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face-to-Face Counseling | Experimental | Participants receive structured tinnitus counseling delivered in person using a standardized educational booklet over a six-week period. |
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| Smartphone-Based Counseling | Experimental | Participants receive the same structured tinnitus counseling delivered via a mobile application with sequential modules over a six-week period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Face-to-Face Tinnitus Counseling | Behavioral | Structured tinnitus counseling is delivered in person using a standardized educational booklet over a six-week period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus Impact | Change in tinnitus impact assessed using the Tinnitus Handicap Inventory (THI). | Baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms | Change in depressive symptoms assessed using the Beck Depression Inventory (BDI). | Baseline to 6 weeks |
| Sleep Quality | Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). |
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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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erciyes University Faculty of Health Sciences | Kayseri | Kayseri | 38000 | Turkey (Türkiye) |
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| Smartphone-Based Tinnitus Counseling | Behavioral | Structured tinnitus counseling is delivered via a mobile application with sequential modules over a six-week period |
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| Baseline to 6 weeks |
| Perceived Tinnitus Severity | Change in perceived tinnitus severity assessed using a Visual Analog Scale (VAS). | Baseline to 6 weeks |
| Tinnitus-Related Annoyance | Change in tinnitus-related annoyance assessed using a Visual Analog Scale (VAS). | Baseline to 6 weeks |