Clinical trial NCT03327506: Preoperative Hypnosis Versus Premedication in Gynecological Surgery
Official title: Efficacity of Hypnosis Versus Premedication for the Management of Perioperative Anxiety in Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gynecologic Disease
Anxiety Disease
Keywords: Premedication/ Hypnosis/ Anxiety/Surgery
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of an hypnosis session, performed on the eve of a laparoscopic gynecological surgery, on the level of immediate preoperative anxiety measured by State-Trait Anxiety Index (STAI-Y) self-administered questionnaire compared to premedication by alprazolam®.


Eligibility criteria: Inclusion Criteria:

* Patient's age: over 18 years
* Patient care and follow-up at the regional maternity center of Nancy (CHRU of Nancy)
* Female patient for whom gynecological laparoscopic surgery is programmed and lasting longer than 1 hour (ovarian cyst, laparoscopy infertility, laparoscopic promontofixation, noncarcinogenic assisted laparoscopy hysterectomy, endometriosis, diagnostic laparoscopy, pyosalpinx, hydrosalpinx)
* Patient with Physical status score (ASA) score between 1 and 3
* With standardized anesthesia protocol
* Patient affiliated to a Social Security
* Patient has received complete information about the organization of the research and has signed her informed consent

Exclusion Criteria:

* Pretreatment by benzodiazepines
* Known hypersensitivity to Alprazolam® (including undocumented)
* Prohibition conditions to Alprazolam®: Severe respiratory insufficiency, Sleep apnea syndrome, Myasthenia, Severe acute or chronic hepatic impairment
* Ongoing major depressive episode
* Chronic use (\> 1 month) of benzodiazepines or morphine or analgesics of level 2
* Participation in a therapeutic trial 6 months before inclusion in this trial
* Patient referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code

Primary outcomes:
measure: Preoperative Anxiety score evaluated by STAI-Y
timeFrame: before surgery (day 2_before)
Secondary outcomes:
measure: Anxiety score evaluated by analogue visual scale
timeFrame: at inclusion visit (day 1), before surgery (day 2_before), after surgery (day 2_after), 24 h after the surgery (day 3)
measure: sleep quality evaluated by EVA scale
timeFrame: day 2_before and the day 3
measure: patient satisfaction score evaluated by EVA scale
timeFrame: day 3
measure: analysis of salivary amylase
timeFrame: day 1 and day2_before
measure: postoperative fatigue evaluated by EVA scale
timeFrame: day 3
measure: Intraoperative morphine and hypnotics drugs Consumption
timeFrame: day 3
measure: Incidence of nausea and vomiting
timeFrame: day 3
measure: Score of pain measured by EVA scale
timeFrame: day 2_after, day 2_recovery room (at the end of recovery room) and Day 3
Other outcomes:
Locations:
city: Nancy
country: France
facility: Florence Vial
Study officials:
References: