Preoperative Hypnosis in Gynecology

Not Applicable

Completed

• Conditions: Pelvic Gynecological Cancer
• Interventions: Behavioral: Caregiver Accompaniment Time (CAT) + preoperative hypnosis session

• Registration Number: NCT03281018
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-09-01
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-13
• Study Start: 2017-11-10
• Primary Completion: 2019-06-26
• Study Completion: 2019-06-26
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-04
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional arm	Caregiver Accompaniment Time (CAT) + preoperative hypnosis session	Caregiver Accompaniment Time (CAT) + preoperative hypnosis session (experimental arm): 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 Outcome Measures

Name	Time	Method
evolution of anxiety	1 month after the surgery	visual analog scale (from 0, no anxiety to 10, extreme anxiety)

Secondary Outcome Measures

Name	Time	Method
nausea and vomiting	2 days, an average of 12 days, and 1 month after the surgery	frequency and intensity through an interview with a nurse
concomitant medication	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)
pain	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)
medical history	The day of the consultation with anesthesist	chronic pathologies (e.g. arterial hypertension, type 2 diabetes) (yes/no)
hypnosis intervention feasibility (composite outcome)	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
length of hospital stay	an average of 12 days after the surgery

Trial Locations

Locations (1)

CHU Bordeaux; 🇫🇷 Bordeau, France