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Clinical Trials/NCT03281018
NCT03281018
Completed
N/A

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

University Hospital, Bordeaux1 site in 1 country29 target enrollmentNovember 10, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pelvic Gynecological Cancer
Sponsor
University Hospital, Bordeaux
Enrollment
29
Locations
1
Primary Endpoint
evolution of anxiety
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 10, 2017
End Date
June 26, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

evolution of anxiety

Time Frame: 1 month after the surgery

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

Secondary Outcomes

  • 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)
  • 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)
  • medical history(The day of the consultation with anesthesist)
  • length of hospital stay(an average of 12 days after the surgery)
  • hypnosis intervention feasibility (composite outcome)(after the hypnosis session (average of 1 week before the surgery))

Study Sites (1)

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