Preoperative Hypnosis in Gynecology

NCT03281018 | Completed

• 1 other identifier: CHUBX 2016/18
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Conditions

Pelvic Gynecological Cancer

Keywords

hypnosis; preoperative anxiety; hysterectomy; hospitalisation

Outcome Measures

Primary Outcomes (1)

• evolution of anxiety

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

  1 month after the surgery

Secondary Outcomes (6)

• 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

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

• 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

• medical history

  The day of the consultation with anesthesist

• length of hospital stay

  an average of 12 days after the surgery

Study Arms (2)

Interventional arm

EXPERIMENTAL

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

Control (CAT)

NO INTERVENTION

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

Interventions

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

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeau, 33000, France

Location

Study Officials

• Jennie SOURZAC

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 13, 2017
• Study Start: November 10, 2017
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

FR (1)