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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Aya Ahmed Elsayed Abdelaal, Resident doctor
- Número de telefone: 01147206609
- E-mail: princess.aya1297@gmail.com
Locais de estudo
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Sohag, Egito
- Sohag faculty of medicine
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Contato:
- Aya Ahmed Elsayed Abdelaal, Resident doctor
- Número de telefone: 01147206609
- E-mail: princess.aya1297@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Group A: patients will receive Sound Therapy
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Group A: Sound Therapy
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Comparador Ativo: 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 Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Primary outcome: Changes in tinnitus severity
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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chang in Visual Analog Scale (VAS) score
Prazo: 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
Prazo: 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
Datas de registro do estudo
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Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
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Outros números de identificação do estudo
- Soh-Med-26-5-8MS
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