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

30. april 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

94

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard group without hypnosis
Patient receiving conventional care without hypnosis
Andet: Unstructured supportive interview
For the control group: unstructured supportive interview with the nurse
Andet: Questionnaires completion
Completion of quality of life questionnaires at inclusion, at 3 months and at 6 months
Eksperimentel: Experimental group with hypnosis
Patient undergoing hypnosis sessions
Andet: Questionnaires completion
Completion of quality of life questionnaires at inclusion, at 3 months and at 6 months
Andet: Hypnosis session
For the experimental group: two hypnosis sessions with the nurse
Andet: Group self-hypnosis
For the experimental group: reinforcement of the hypnosis technique with a group self-hypnosis session

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluating the effectiveness of hypnotherapy on women's overall quality of life at 3 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months after the inclusion
Sleep disorders will be assessed using the Insomnia Severity Index (ISI) questionnaire.
6 months after the inclusion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Toulouse

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • RC31/25/0564
  • ID-RCB (Anden identifikator: 2026-A00289-42)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Unstructured supportive interview

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner