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NCT Number: NCT07572981

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

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.

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Key information

Conditions

Menopause

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Toulouse, Oui, 31300, France

Location contact

Emeline MULLER

CONTACT

[email protected]

0561778707

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypnosis session

Other

For the experimental group: two hypnosis sessions with the nurse

Group self-hypnosis

Other

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

Unstructured supportive interview

Other

For the control group: unstructured supportive interview with the nurse

questionnaires completion

Other

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

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.

    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

Secondary outcomes

  1. 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

  2. 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

  3. Evaluation of the tolerance of hypnotherapy

    Time frame: 6 months after the inclusion

    Measuring tolerance using an adverse event questionnaire

  4. 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).

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle MOREAU

CONTACT

[email protected]

0567771182 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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

Acronym: HYPNOMENO-2

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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