MenopauseHYPNOMENO-2NCT07572981
Study of the Effectiveness of Clinical Hypnosis and Self-hypnosis in Relieving Hot Flashes in Menopausal Women
A study testing Hypnosis session, Group self-hypnosis and Unstructured supportive interview in people with Menopause, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Menopause
- What is being tested?
- Hypnosis session, Group self-hypnosis and Unstructured supportive interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre de ménopause, Hôpital Paule de Viguier, 330 avenue Grande Bretagne
Toulouse, Oui, 31300
Emeline MULLER, 0561778707, muller.e@chu-toulouse.Fr
About this study
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
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
- Being tested
- Hypnosis session, Group self-hypnosis, Unstructured supportive interview, Questionnaires completion
- Keywords
- menopause, hot flashes menopause, hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis sessionOther
For the experimental group: two hypnosis sessions with the nurse
Group self-hypnosisOther
For the experimental group: reinforcement of the hypnosis technique with a group self-hypnosis session
Unstructured supportive interviewOther
For the control group: unstructured supportive interview with the nurse
Questionnaires completionOther
Completion of quality of life questionnaires at inclusion, at 3 months and at 6 months
| Study group | Role | What they receive |
|---|---|---|
| Standard group without hypnosis | Active comparator | Patient receiving conventional care without hypnosis Receives: Other: Unstructured supportive interview; Other: Questionnaires completion |
| Experimental group with hypnosis | Experimental | Patient undergoing hypnosis sessions Receives: Other: Hypnosis session; Other: Group self-hypnosis; Other: Questionnaires completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after the inclusion
Secondary outcomes (5)
Evaluating the effectiveness of hypnotherapy on women's overall quality of life at 3 months
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
Measured: 3 months after the inclusion
Evaluate the effectiveness of hypnotherapy on the frequency of hot flashes
Measurement of the total number of hot flashes recorded daily over 7 days
Measured: 6 months after the inclusion
Evaluation of the tolerance of hypnotherapy
Measuring tolerance using an adverse event questionnaire
Measured: 6 months after the inclusion
Evaluation of the effectiveness of hypnotherapy on depressive symptoms
Depressive symptoms will be assessed using the validated Patient Health Questionnaire-9 (PHQ-9).
Measured: 6 months after the inclusion
Evaluation of the effectiveness of hypnotherapy on sleep disorders
Sleep disorders will be assessed using the Insomnia Severity Index (ISI) questionnaire.
Measured: 6 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572981
- Sponsor's protocol ID
- RC31/25/0564
- Other IDs
- ID-RCB
- Acronym
- HYPNOMENO-2
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07572981
- Acronym / sponsor ID
- HYPNOMENO-2 / RC31/25/0564
- Conditions
- Menopause
- Keywords
- menopause, hot flashes menopause, hypnosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group without hypnosis | Active comparator | Other: Unstructured supportive interview, Other: Questionnaires completionPatient receiving conventional care without hypnosis |
| Experimental group with hypnosis | Experimental | Other: Hypnosis session, Other: Group self-hypnosis, Other: Questionnaires completionPatient undergoing hypnosis sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnosis sessionFor the experimental group: two hypnosis sessions with the nurse | Other | Experimental group with hypnosis |
| Group self-hypnosisFor the experimental group: reinforcement of the hypnosis technique with a group self-hypnosis session | Other | Experimental group with hypnosis |
| Unstructured supportive interviewFor the control group: unstructured supportive interview with the nurse | Other | Standard group without hypnosis |
| Questionnaires completionCompletion of quality of life questionnaires at inclusion, at 3 months and at 6 months | Other | Experimental group with hypnosis, Standard group without hypnosis |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis session, Group self-hypnosis and Unstructured supportive interview in people with Menopause, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle MOREAU (0567771182 ext. +33, moreau.c@chu-toulouse.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.