Study of the Effectiveness of Clinical Hypnosis and Self-hypnosis in Relieving Hot Flashes in Menopausal Women

Официальное название

Study of the Effectiveness of Clinical Hypnosis and Self-hypnosis in Relieving Hot Flashes in Menopausal Women With no Indication for Menopausal Hormone Therapy

Обзор

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.

Вмешательства

• Другое Hypnosis session
  For the experimental group: two hypnosis sessions with the nurse
• Другое Group self-hypnosis
  For the experimental group: reinforcement of the hypnosis technique with a group self-hypnosis session
• Другое Unstructured supportive interview
  For the control group: unstructured supportive interview with the nurse
• Другое Questionnaires completion
  Completion of quality of life questionnaires at inclusion, at 3 months and at 6 months

Первичные конечные точки

• 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. [Срок оценки: 6 months after the inclusion]

Вторичные конечные точки (5)

• Evaluating the effectiveness of hypnotherapy on women's overall quality of life at 3 months [Срок оценки: 3 months after the inclusion]
• Evaluate the effectiveness of hypnotherapy on the frequency of hot flashes [Срок оценки: 6 months after the inclusion]
• Evaluation of the tolerance of hypnotherapy [Срок оценки: 6 months after the inclusion]
• Evaluation of the effectiveness of hypnotherapy on depressive symptoms [Срок оценки: 6 months after the inclusion]
• Evaluation of the effectiveness of hypnotherapy on sleep disorders [Срок оценки: 6 months after the inclusion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Centre de ménopause, Hôpital Paule de Viguier, 330 avenue Grande Bretagne — Toulouse

Идентификаторы

NCT: NCT07572981 · RC31/25/0564 · ID-RCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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