Trial of Management of Chronic Tinnitus by Sound Therapy and Cognitive Behavioral Therapy
Efficacy of Sound Therapy, Cognitive Behavioral Therapy and Their Combination in Management of Chronic Tinnitus
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:
- Group A: patients will receive Sound Therapy.
- Group B: patients will receive Cognitive Behavioral Therapy (CBT).
- Group C: patients will receive Combined CBT + Sound Therapy.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Aya Ahmed Elsayed Abdelaal, Resident doctor
- Número de teléfono: 01147206609
- Correo electrónico: princess.aya1297@gmail.com
Ubicaciones de estudio
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Sohag, Egipto
- Sohag faculty of medicine
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Contacto:
- Aya Ahmed Elsayed Abdelaal, Resident doctor
- Número de teléfono: 01147206609
- Correo electrónico: princess.aya1297@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
o Age: 18-65 years.
- Hearing level: Patients with normal hearing or mild to moderate sensorineural hearing loss (to ensure homogeneity of the sample) (National Institute for Health and Care Excellence, 2020)
- Complaint: patients with chronic subjective tinnitus (> 3 months).
- Psychological state: Patients with stable general and psychological condition.
Exclusion Criteria:
o Age: <18, >65 years
- Hearing level: Patients with severe hearing loss not suitable for sound therapy
- Complaint: Objective tinnitus (vascular or muscular origin)
- Psychological state: Patients with active psychiatric disorders requiring immediate intervention.
- Active middle or external ear disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Group A: patients will receive Sound Therapy
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Group A: Sound Therapy
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Comparador activo: Group B: patients will receive Cognitive Behavioral Therapy (CBT).
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Group B: Cognitive Behavioral Therapy (CBT) • Structured CBT program consisting of 6 sessions over 6 weeks. Each session categorization:
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Comparador activo: Group C: patients will receive Combined CBT + Sound Therapy.
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Group A: Sound Therapy
Group B: Cognitive Behavioral Therapy (CBT) • Structured CBT program consisting of 6 sessions over 6 weeks. Each session categorization:
Group C: Combined Therapy • Patients will receive both sound therapy and CBT simultaneously following the same protocol as above. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Primary outcome: Changes in tinnitus severity
Periodo de tiempo: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
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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
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Baseline, immediately after completion of treatment , and 3 months after completion of treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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chang in Visual Analog Scale (VAS) score
Periodo de tiempo: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
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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
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Baseline, immediately after completion of treatment , and 3 months after completion of treatment
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change in Tinnitus Handicap Inventory (THI) score
Periodo de tiempo: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
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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.
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Baseline, immediately after completion of treatment , and 3 months after completion of treatment
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Soh-Med-26-5-8MS
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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