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Completed

NCT Number: NCT03281018

Preoperative Hypnosis in Gynecology

The research hypotheses that preoperative formal hypnosis session reduces perioperative anxiety among women undergoing a hysterectomy for pelvic gynecological cancer. The key objective is to estimate the effect of preoperative hypnosis on preoperative anxiety among this population

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Key information

Conditions

Pelvic Gynecological Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux

Bordeau, 33000, France

About this study

Anxiety is present preoperatively in 40% of patients. The operated subjects are on average 20% more anxious than the general population, according to a study of 2013. Cancer as well as surgery modifying the body pattern and impairing femininity are risk factors for preoperative anxiety. Recent work in both children and adults has shown that significant levels of preoperative anxiety increase the risk of postoperative complications and the occurrence of postoperative emotional and behavioral disorders. The consequences of hysterectomy increase patients' anxiety, for fear of affecting femininity, and the modification of the body regimen. The prevention of preoperative anxiety in such population is therefore a major issue.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ 18yrs with pelvic gynecological cancer (endometrium, cervix, ovary),
  • at any stage of the disease;
  • patient coming for anesthesia consultation before hysterectomy,
  • informed signed consent,
  • patient affiliated to or beneficiary of social security.

Exclusion criteria

  • patient <18yrs,
  • patient with a pelvic gynecological cancer that does not require hysterectomy;
  • patient with psychiatric history or a depressive syndrome;
  • deaf patient (deafness makes the hypnosis session impossible),
  • patient under legal protection.

Treatment and study plan

Caregiver Accompaniment Time (CAT) + preoperative hypnosis session

Behavioral

The hypnosis session is performed by a nurse trained in medical hypnosis; this interview lasts approximately one hour and is carried out 5 to 15 days before the hospitalisation. During the hypnosis session, the patient is free to choose what issues she wants to address. The patient will then go from a state of ordinary consciousness to a modified state of consciousness. This state will allow her to activate her own resources to handle difficulties, especially anxiety. Using a post-hypnotic suggestion, the patient will be able to revisit her work at any time she needs

Primary outcomes

  1. evolution of anxiety

    Time frame: 1 month after the surgery

    visual analog scale (from 0, no anxiety to 10, extreme anxiety)

Secondary outcomes

  1. pain

    Time frame: The day of the consultation with anesthesist, the day before the surgery, 2 days, an average of 12 days, and 1 month after the surgery

    numerical scale of pain (from 0, no pain, to 10, extreme pain)

  2. nausea and vomiting

    Time frame: 2 days, an average of 12 days, and 1 month after the surgery

    frequency and intensity through an interview with a nurse

  3. concomitant medication

    Time frame: The day of the consultation with anesthesist, the day before the surgery, 2 days, an average of 12 days, and 1 month after the surgery

    concomitant medication within anxiolytic, antalgic, and/or antiemetic pharmaceutical classes (yes/no)

  4. medical history

    Time frame: The day of the consultation with anesthesist

    chronic pathologies (e.g. arterial hypertension, type 2 diabetes) (yes/no)

  5. length of hospital stay

    Time frame: an average of 12 days after the surgery

  6. hypnosis intervention feasibility (composite outcome)

    Time frame: after the hypnosis session (average of 1 week before the surgery)

    Compliance with the formal Hypnosis session checklist (Installation, pre-session interview, kinesthetic induction, dissociation, deepening, post-hypnotic suggestions and anchoring, return to normal wakefulness)

    Other factors: proportion of refusals, proportion of abandoned, proportion of lost sight

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Exploratory Study of the Impact of a Preoperative Formal Hypnosis Session on Perioperative Anxiety Among Female Patients Hospitalised for Hysterectomy Due to Pelvic Gynecological Cancer

Acronym: HYPPOGYN

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2017
Registry last updated
May 14, 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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