Preoperative Hypnosis in Gynecology (HYPPOGYN)

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

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

Study Overview

• Status: Completed
• Conditions: Pelvic Gynecological Cancer
• Intervention / Treatment: Behavioral: Caregiver Accompaniment Time (CAT) + preoperative hypnosis session

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeau, France, 33000
    • CHU Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm; 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	Behavioral: Caregiver Accompaniment Time (CAT) + preoperative hypnosis session; 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
No Intervention: Control (CAT); CAT is performed in routine care for all patients after the announcement of the illness by a trained nurse, if possible on the same day as the consultation or before the consultation of anesthesia. This is an interview of approximately 45 minutes to listen to the patient, to answer her questions and to re-explain the information delivered to her. The patient will tackle the history of the disease and then the treatment, this time dedicated evolves according to the desire of the patient and her ability to accept the disease. The patient can express her feelings, then the family circle is evoked talking about the resource persons and the future. The purpose of this interview is to obtain the autonomy of the patient by the setting up of supportive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evolution of anxiety	visual analog scale (from 0, no anxiety to 10, extreme anxiety)	1 month after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	numerical scale of pain (from 0, no pain, to 10, extreme 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
nausea and vomiting	frequency and intensity through an interview with a nurse	2 days, an average of 12 days, and 1 month after the surgery
concomitant medication	concomitant medication within anxiolytic, antalgic, and/or antiemetic pharmaceutical classes (yes/no)	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
medical history	chronic pathologies (e.g. arterial hypertension, type 2 diabetes) (yes/no)	The day of the consultation with anesthesist
length of hospital stay		an average of 12 days after the surgery
hypnosis intervention feasibility (composite outcome)	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	after the hypnosis session (average of 1 week before the surgery)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Jennie SOURZAC, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2017
• Primary Completion (Actual): June 26, 2019
• Study Completion (Actual): June 26, 2019

Study Registration Dates

• First Submitted: September 1, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 4, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: hysterectomy; hypnosis; preoperative anxiety; hospitalisation
• Other Study ID Numbers: CHUBX 2016/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No