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clinical trial: The main aim of this study is to compare the effectiveness of Cognitive Behavioral Therapy (CBT) and Sound Therapy, both individually and in combination, in the management of patients with chronic subjective tinnitus and to evaluate their impact on decreasing tinnitus severity, psychological wellbeing and quality of life.
Patients will be randomly divided into three groups:
Because of the multifactorial nature of tinnitus, its effective management requires a multidisciplinary approach. While there is no single pullet mechanism of cure, current treatment strategies primary focus on reducing tinnitus related perception and minimizing its associated distress through auditory and psychological interventions.
Among these approaches, is the Sound Therapy which aims to decrease the contrast between tinnitus and related neural activity by introducing external sounds, which facilitates habituation and reducing tinnitus perception .
In contrast, Cognitive Behavioral Therapy (CBT) targets the patient's cognitive and emotional reaction to tinnitus by modifying maladaptive thoughts and behaviors, there by improving coping strategies and reducing tinnitus-related distress (Andersson, 2011). Recent evidence suggests that combining both modalities may provide superior outcomes compared to either approach alone, highlighting the potential value for integrated treatment strategies in tinnitus management (Hall et
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: patients will receive Sound Therapy | Active Comparator |
| |
| Group B: patients will receive Cognitive Behavioral Therapy (CBT). | Active Comparator |
| |
| Group C: patients will receive Combined CBT + Sound Therapy. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A: sound therapy | Behavioral | Group A: Sound Therapy
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| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome: Changes in tinnitus severity | Assessment of tinnitus severity using the Tinnitus Functional Index (TFI) . Higher scores indicate greater tinnitus severity. the TFI total score ranges from 0 to 100, with higher score s indicating greater tinnitus severity and functional impact | Baseline, immediately after completion of treatment , and 3 months after completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| chang in Visual Analog Scale (VAS) score | Assessment of tinnitus severity using the Visual Analog Scale (VAS) . the VAS score ranges from 0 to 10, with 0 indicate no tinnitus and 10 indicates the worst imaginable tinnitus. higher scores indicating greater tinnitus severity | Baseline, immediately after completion of treatment , and 3 months after completion of treatment |
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Inclusion Criteria:
o Age: 18-65 years.
Exclusion Criteria:
o Age: <18, >65 years
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aya Ahmed Elsayed Abdelaal, Resident doctor | Contact | 01147206609 | princess.aya1297@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag faculty of medicine | Sohag | Egypt |
No decision has been made regarding the sharing of individual participant data at this time
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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Model Description
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Masking Description
|
| Group B: Cognitive Behavioral Therapy | Behavioral | Group B: Cognitive Behavioral Therapy (CBT) • Structured CBT program consisting of 6 sessions over 6 weeks. Each session categorization:
|
|
| Group C: Combined CBT + Sound Therapy | Behavioral | Group C: Combined Therapy • Patients will receive both sound therapy and CBT simultaneously following the same protocol as above. |
|
| change in Tinnitus Handicap Inventory (THI) score | Assessment of tinnitus-related handicap and quality of life using Tinnitus Handicap Inventory (THI). the THI total score ranges from 0 to 100, with higher scores indicating greater tinnitus-related handicap and poorer quality of life. | Baseline, immediately after completion of treatment , and 3 months after completion of treatment |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |