Clinical trial NCT03281018: Preoperative Hypnosis in Gynecology
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Gynecological Cancer
Keywords: hypnosis
preoperative anxiety
hysterectomy
hospitalisation
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: evolution of anxiety
timeFrame: 1 month after the surgery
Secondary outcomes:
measure: pain
timeFrame: 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
measure: nausea and vomiting
timeFrame: 2 days, an average of 12 days, and 1 month after the surgery
measure: concomitant medication
timeFrame: 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
measure: medical history
timeFrame: The day of the consultation with anesthesist
measure: length of hospital stay
timeFrame: an average of 12 days after the surgery
measure: hypnosis intervention feasibility (composite outcome)
timeFrame: after the hypnosis session (average of 1 week before the surgery)
Other outcomes:
Locations:
city: Bordeau
country: France
facility: CHU Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Jennie SOURZAC
role: PRINCIPAL_INVESTIGATOR
References: