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

NCT07572981 | Not Yet Recruiting DMC

• 2 other identifiers: RC31/25/0564ID-RCB
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Menopause

Keywords

menopause; hot flashes menopause; hypnosis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Secondary Outcomes (5)

• Evaluating the effectiveness of hypnotherapy on women's overall quality of life at 3 months

  3 months after the inclusion

• Evaluate the effectiveness of hypnotherapy on the frequency of hot flashes

  6 months after the inclusion

• Evaluation of the tolerance of hypnotherapy

  6 months after the inclusion

• Evaluation of the effectiveness of hypnotherapy on depressive symptoms

  6 months after the inclusion

• Evaluation of the effectiveness of hypnotherapy on sleep disorders

  6 months after the inclusion

Study Arms (2)

Standard group without hypnosis

ACTIVE COMPARATOR

Patient receiving conventional care without hypnosis

Other: Unstructured supportive interview; Other: Questionnaires completion

Experimental group with hypnosis

EXPERIMENTAL

Patient undergoing hypnosis sessions

Other: Hypnosis session; Other: Group self-hypnosis; Other: Questionnaires completion

Interventions

Hypnosis session OTHER

For the experimental group: two hypnosis sessions with the nurse

Experimental group with hypnosis

Group self-hypnosis OTHER

For the experimental group: reinforcement of the hypnosis technique with a group self-hypnosis session

Experimental group with hypnosis

Unstructured supportive interview OTHER

For the control group: unstructured supportive interview with the nurse

Standard group without hypnosis

Questionnaires completion OTHER

Completion of quality of life questionnaires at inclusion, at 3 months and at 6 months

Experimental group with hypnosis; Standard group without hypnosis

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study concerns menopausal disorders, experienced only by women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient under 18
• Patient undergoing menopausal hormone therapy
• Patient who had a hypnosis session within the last 6 months

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Centre de ménopause, Hôpital Paule de Viguier, 330 avenue Grande Bretagne

Toulouse, Oui, 31300, France

Location

Central Study Contacts

Christelle MOREAU

CONTACT

0567771182; moreau.c@chu-toulouse.Fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)