Menopause
Conditions
Keywords
menopause, hot flashes menopause, hypnosis
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.
Interventions
OTHERHypnosis session
For the experimental group: two hypnosis sessions with the nurse
OTHERGroup self-hypnosis
For the experimental group: reinforcement of the hypnosis technique with a group self-hypnosis session
OTHERUnstructured supportive interview
For the control group: unstructured supportive interview with the nurse
Completion of quality of life questionnaires at inclusion, at 3 months and at 6 months
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluating the effectiveness of hypnotherapy on women's overall quality of life at 3 months | 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 |
| Evaluate the effectiveness of hypnotherapy on the frequency of hot flashes | 6 months after the inclusion | Measurement of the total number of hot flashes recorded daily over 7 days |
| Evaluation of the tolerance of hypnotherapy | 6 months after the inclusion | Measuring tolerance using an adverse event questionnaire |
| Evaluation of the effectiveness of hypnotherapy on depressive symptoms | 6 months after the inclusion | Depressive symptoms will be assessed using the validated Patient Health Questionnaire-9 (PHQ-9). |
| Evaluation of the effectiveness of hypnotherapy on sleep disorders | 6 months after the inclusion | Sleep disorders will be assessed using the Insomnia Severity Index (ISI) questionnaire. |
Countries
France
Contacts
CONTACTChristelle MOREAU
Outcome results
None listed