Preoperative Hypnosis in Gynecology

NCT ID: NCT03281018

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-10
• Study Completion Date: 2019-06-26

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.

Conditions

Pelvic Gynecological Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Caregiver Accompaniment Time (CAT) + preoperative hypnosis session

Intervention Type: 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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennie SOURZAC

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU Bordeaux

Bordeau, , France

Countries

France

Other Identifiers

CHUBX 2016/18

Identifier Type: -

Identifier Source: org_study_id