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.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Christelle MOREAU
- 电话号码：+33 0567771182
- 邮箱：moreau.c@chu-toulouse.Fr
学习地点
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-
Oui
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Toulouse、Oui、法国、31300
- Centre de ménopause, Hôpital Paule de Viguier, 330 avenue Grande Bretagne
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接触：
- Emeline Muller
- 电话号码：0561778707
- 邮箱：muller.E@chu-toulouse.Fr
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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.
大体时间：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
|
6 months after the inclusion
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluating the effectiveness of hypnotherapy on women's overall quality of life at 3 months
大体时间：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
|
3 months after the inclusion
|
|
Evaluate the effectiveness of hypnotherapy on the frequency of hot flashes
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- RC31/25/0564
- ID-RCB (其他标识符：2025-A00414-45)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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