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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Christelle MOREAU
- 전화번호: +33 0567771182
- 이메일: moreau.c@chu-toulouse.Fr
연구 장소
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Oui
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Toulouse, Oui, 프랑스, 31300
- Centre de ménopause, Hôpital Paule de Viguier, 330 avenue Grande Bretagne
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연락하다:
- Emeline MULLER
- 전화번호: 0561778707
- 이메일: muller.e@chu-toulouse.Fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Evaluating the effectiveness of hypnotherapy on women's overall quality of life at 3 months
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RC31/25/0564
- ID-RCB (기타 식별자: 2025-A02239-40)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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