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治験 NCT04513444 (HYPNOMUSE)（対象：固形腫瘍）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy (HYPNOMUSE)
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT04513444 (HYPNOMUSE) は 固形腫瘍 に関する 支持療法 の研究で、第II相・第二段階 介入研究 臨床試験 です。現在は 募集中 で、2020年12月7日 から開始しています。45 名の参加者 の募集が計画されています。この治験は Institut Claudius Regaud によって主催され、2026年2月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年4月4日 です。
概要
This phase II, randomized, non-comparative and monocentric study aims to evaluate the interest of medical hypnosis in the management of anxiety in patients who are moderately anxious, anxious or very anxious during their radiotherapy treatment.
45 patients will be randomized into the following arms:
- Arm A (standard): relaxation with music listening during radiotherapy treatment
- Arm B (experimental): relaxation with music listening and hypnosis during radiotherapy treatment
For the study each patient will be followed during 2 months.
公式タイトル
Phase II Study Aiming to Evaluate the Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy
疾患／病気
固形腫瘍その他の研究識別子
- HYPNOMUSE
- 20 GENE 07
NCT番号
開始日
2020-12-07
最終更新日
2025-04-04
終了予定日
2026-02
目標参加者数
45
試験の種類
介入研究
治験の相・段階
第II相・第二段階
状況
募集中
キーワード
Solid Tumor
Radiotherapy
Hypnosis
Anxiety
Music listening
Radiotherapy
Hypnosis
Anxiety
Music listening
主目的
支持療法
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
その他Standard arm (A): music listening therapy | Relaxation with Music Listening During Radiotherapy Treatment: * Music listening (According to the patient's wishes),
* Questionnaires (STAI-Y and QLQ-C30) and numerical scales (anxiety and pain) will be completed by patients during radiotherapy consultations. |
実験的Experimental arm (B): music listening and hypnosis therapy | Relaxation with Music Listening and Medical Hypnosis During Radiotherapy Treatment: * Music listening (According to the patient's wishes),
* Hypnosis sessions with the hypnotherapist during the 1st, 2nd and 3rd radiotherapy session,
* Self-hypnosis during the 4th and 5th radiotherapy session,
* Questionnaires (STAI-Y and QLQ-C30) and numerical scales (anxiety and pain) will be completed by patients during radiotherapy consultations. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Rate of patients with at least a 10-point decrease in anxiety score (evolution between the baseline and the 6th and last radiotherapy session) | Anxiety will be assessed using the STAI-Y questionnaire (Spielberger State-Trait Anxiety Inventory - State Anxiety form). | 2 months for each patient |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Anxiety assessed using a numerical scale from 0 to 10 (0 being "not at all anxious" and 10 being "extremely anxious") | 2 months for each patient | |
Quality of life assessed using the EORTC (European Organization for Research and Treatment of Cancer) Quality of life questionnaire (QLQ-C30). | Changes in quality of life from baseline will be assessed in the classroom according to the recommendations of the literature (Osoba, JCO). | 2 months for each patient |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Age ≥ 18 years at the time of enrollment into the study.
- Patient with localized or metastatic solid malignant tumor.
- Patient being followed for the cancer pathology at IUCT-O and to receive, for the first time in the follow-up, treatment by radiotherapy (radiotherapy treatment should not have been initiated prior to inclusion in the study).
- Patient for whom radiotherapy treatment includes at least 15 sessions of radiation therapy.
- Patient defined as moderately anxious, anxious or very anxious after completing the STAI-Y self-assessment questionnaire (i.e. ≥ 46 score at inclusion).
- ECOG patient ≤ 2.
- Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
- Patient affiliated to a Social Health Insurance in France.
- Patient doesn't understand the French language.
- Patient with psychiatric disorders requiring antidepressant or antipsychotic treatment.
- Patient with hearing problems.
- Pregnant or breastfeeding women.
- Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Institut Claudius Regaud試験中央連絡先
連絡先: Anne DUCASSOU, 05 31 15 54 15, [email protected]
1 1カ国の場所
Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse, 31059, France
Anne DUCASSOU, 連絡先, 05 31 15 54 15, [email protected]
募集中