Study of the Effectiveness of Clinical Hypnosis and Self-hypnosis in Relieving Hot Flashes in Menopausal Women (HYPNOMENO-2)

April 30, 2026 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Oui
      • Toulouse, Oui, France, 31300
        • Centre de ménopause, Hôpital Paule de Viguier, 330 avenue Grande Bretagne
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard group without hypnosis
Patient receiving conventional care without hypnosis
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
Experimental: Experimental group with hypnosis
Patient undergoing hypnosis sessions
Other: Questionnaires completion
Completion of quality of life questionnaires at inclusion, at 3 months and at 6 months
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the effectiveness of hypnotherapy on women's overall quality of life at 3 months
Time Frame: 3 months after the inclusion
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
Time Frame: 6 months after the inclusion
Measurement of the total number of hot flashes recorded daily over 7 days
6 months after the inclusion
Evaluation of the tolerance of hypnotherapy
Time Frame: 6 months after the inclusion
Measuring tolerance using an adverse event questionnaire
6 months after the inclusion
Evaluation of the effectiveness of hypnotherapy on depressive symptoms
Time Frame: 6 months after the inclusion
Depressive symptoms will be assessed using the validated Patient Health Questionnaire-9 (PHQ-9).
6 months after the inclusion
Evaluation of the effectiveness of hypnotherapy on sleep disorders
Time Frame: 6 months after the inclusion
Sleep disorders will be assessed using the Insomnia Severity Index (ISI) questionnaire.
6 months after the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC31/25/0564
  • ID-RCB (Other Identifier: 2026-A00289-42)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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