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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Aya Ahmed Elsayed Abdelaal, Resident doctor
- Numéro de téléphone: 01147206609
- E-mail: princess.aya1297@gmail.com
Lieux d'étude
-
-
-
Sohag, Egypte
- Sohag faculty of medicine
-
Contact:
- Aya Ahmed Elsayed Abdelaal, Resident doctor
- Numéro de téléphone: 01147206609
- E-mail: princess.aya1297@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Group A: patients will receive Sound Therapy
|
Group A: Sound Therapy
|
|
Comparateur actif: Group B: patients will receive Cognitive Behavioral Therapy (CBT).
|
Group B: Cognitive Behavioral Therapy (CBT) • Structured CBT program consisting of 6 sessions over 6 weeks. Each session categorization:
|
|
Comparateur actif: Group C: patients will receive Combined CBT + Sound Therapy.
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Primary outcome: Changes in tinnitus severity
Délai: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
chang in Visual Analog Scale (VAS) score
Délai: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
|
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
|
|
change in Tinnitus Handicap Inventory (THI) score
Délai: Baseline, immediately after completion of treatment , and 3 months after completion of treatment
|
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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Soh-Med-26-5-8MS
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .