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Not yet recruiting NCT07572981

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

No phase Interventional Menopause

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypnosis session, Group self-hypnosis, Unstructured supportive interview, Questionnaires completion.
Who it may be relevant to
Registry conditions: Menopause. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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. [Time frame: 6 months after the inclusion]
Secondary outcome measures (5)
  • Evaluating the effectiveness of hypnotherapy on women's overall quality of life at 3 months [Time frame: 3 months after the inclusion]
  • Evaluate the effectiveness of hypnotherapy on the frequency of hot flashes [Time frame: 6 months after the inclusion]
  • Evaluation of the tolerance of hypnotherapy [Time frame: 6 months after the inclusion]
  • Evaluation of the effectiveness of hypnotherapy on depressive symptoms [Time frame: 6 months after the inclusion]
  • Evaluation of the effectiveness of hypnotherapy on sleep disorders [Time frame: 6 months after the inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Centre de ménopause, Hôpital Paule de Viguier, 330 avenue Grande Bretagne — Toulouse

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗