Study of the Effectiveness of Clinical Hypnosis and Self-hypnosis in Relieving Hot Flashes in Menopausal Women (HYPNOMENO-2)
Study of the Effectiveness of Clinical Hypnosis and Self-hypnosis in Relieving Hot Flashes in Menopausal Women With no Indication for Menopausal Hormone Therapy
The onset of menopause is accompanied by a significant drop in blood estradiol levels, the main symptom of which is hot flashes. These are present in 80% of menopausal women and are debilitating in 25% of cases.
Although estrogen therapy is the most effective treatment for managing menopausal symptoms, numerous non-hormonal alternatives, both pharmacological and non-pharmacological, have been evaluated for managing menopausal symptoms. Among these, hypnosis has shown promise in several studies.
However, to our knowledge, there are no studies that evaluate the longer-term effectiveness of hypnotherapy on menopausal symptoms (beyond 3 months after the start of treatment). Furthermore, there is very little data on the effectiveness of hypnotherapy on the overall quality of life of these women, independent of hot flashes, nor on other symptoms related to menopause. A first pilot study, neither randomized nor controlled, is currently underway, and we hope to continue the project with a robust controlled study.
調査の概要
状態
条件
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：Christelle MOREAU
- 電話番号：+33 0567771182
- メール：moreau.c@chu-toulouse.Fr
研究場所
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Oui
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Toulouse、Oui、フランス、31300
- Centre de ménopause, Hôpital Paule de Viguier, 330 avenue Grande Bretagne
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コンタクト：
- Emeline MULLER
- 電話番号：0561778707
- メール：muller.e@chu-toulouse.Fr
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adult patient
- Patient with amenorrhea for at least 12 months or with a history of bilateral oophorectomy.
- Patient with debilitating symptoms related to menopause, who consulted a physician at the Menopause and Osteoporosis Prevention Center at Paule de Viguier Hospital, Toulouse University Hospital, and was referred for hypnosis consultation by that physician.
Exclusion Criteria:
- Patient under 18
- Patient undergoing menopausal hormone therapy
- Patient using another therapeutic alternative for hot flashes validated against placebo in the literature at the time of inclusion: neurokinin 3 receptor antagonists, selective serotonin reuptake inhibitors, clonidine, gabapentin, acupuncture
- Patient who had a hypnosis session within the last 6 months
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：Standard group without hypnosis
Patient receiving conventional care without hypnosis
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For the control group: unstructured supportive interview with the nurse
Completion of quality of life questionnaires at inclusion, at 3 months and at 6 months
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実験的：Experimental group with hypnosis
Patient undergoing hypnosis sessions
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Completion of quality of life questionnaires at inclusion, at 3 months and at 6 months
For the experimental group: two hypnosis sessions with the nurse
For the experimental group: reinforcement of the hypnosis technique with a group self-hypnosis session
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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 |
|---|---|---|
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Evaluation of the effectiveness at 6 months of hypnotherapy on the overall quality of life of menopausal women compared to a simple empathic support technique.
時間枠：6 months after the inclusion
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The effectiveness of hypnotherapy in treating the side effects of menopause will be assessed with the score calculated from the MENQOL questionnaire at 6 months
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6 months after the inclusion
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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 |
|---|---|---|
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Evaluating the effectiveness of hypnotherapy on women's overall quality of life at 3 months
時間枠：3 months after the inclusion
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The effectiveness of hypnotherapy in treating the side effects of menopause will be assessed with the score calculated from the MENQOL questionnaire at 3 months
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3 months after the inclusion
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Evaluate the effectiveness of hypnotherapy on the frequency of hot flashes
時間枠：6 months after the inclusion
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Measurement of the total number of hot flashes recorded daily over 7 days
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6 months after the inclusion
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Evaluation of the tolerance of hypnotherapy
時間枠：6 months after the inclusion
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Measuring tolerance using an adverse event questionnaire
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6 months after the inclusion
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Evaluation of the effectiveness of hypnotherapy on depressive symptoms
時間枠：6 months after the inclusion
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Depressive symptoms will be assessed using the validated Patient Health Questionnaire-9 (PHQ-9).
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6 months after the inclusion
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Evaluation of the effectiveness of hypnotherapy on sleep disorders
時間枠：6 months after the inclusion
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Sleep disorders will be assessed using the Insomnia Severity Index (ISI) questionnaire.
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6 months after the inclusion
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協力者と研究者
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
キーワード
その他の研究ID番号
- RC31/25/0564
- ID-RCB (その他の識別子：2025-A02239-40)
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?
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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。
Unstructured supportive interviewの臨床試験
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