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.
調査の概要
状態
条件
詳細な説明
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
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Aya Ahmed Elsayed Abdelaal, Resident doctor
- 電話番号：01147206609
- メール：princess.aya1297@gmail.com
研究場所
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Sohag、エジプト
- Sohag faculty of medicine
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コンタクト：
- Aya Ahmed Elsayed Abdelaal, Resident doctor
- 電話番号：01147206609
- メール：princess.aya1297@gmail.com
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-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Group A: patients will receive Sound Therapy
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Group A: Sound Therapy
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アクティブコンパレータ：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:
|
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アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Primary outcome: Changes in tinnitus severity
時間枠：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
|
Baseline, immediately after completion of treatment , and 3 months after completion of treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
chang in Visual Analog Scale (VAS) score
時間枠：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
時間枠：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.
|
Baseline, immediately after completion of treatment , and 3 months after completion of treatment
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- Soh-Med-26-5-8MS
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。