Preoperative Hypnosis in Gynecology

Pelvic Gynecological Cancer Clinical Trial

— HYPPOGYN  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281018
• Other study ID #: CHUBX 2016/18
• Status: Completed
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: June 26, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Gynecological Cancer

Intervention

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

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeau

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evolution of anxiety	visual analog scale (from 0, no anxiety to 10, extreme anxiety)	1 month after the surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	medical history	chronic pathologies (e.g. arterial hypertension, type 2 diabetes) (yes/no)	The day of the consultation with anesthesist
Secondary	length of hospital stay		an average of 12 days after the surgery
Secondary	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)