Preoperative Hypnosis Versus Premedication in Gynecological Surgery

Study Overview
=================
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®.

Official Title
-----------------
Efficacity of Hypnosis Versus Premedication for the Management of Perioperative Anxiety in Gynecological Surgery

Conditions
-----------------
Gynecologic Disease, Anxiety Disease

Intervention / Treatment
-----------------
* Drug: Alprazolam 0.5 mg


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypnosis group<br>Intervention: hypnosis session the eve of the surgery | Drug: Alprazolam 0.5 mg<br>* alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session<br>* Other names: hypnosis;|
| Active Comparator: premedication<br>alprazolam 0,5 mg the eve and the morning of the surgery | Drug: Alprazolam 0.5 mg<br>* alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session<br>* Other names: hypnosis;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative Anxiety score evaluated by STAI-Y | evaluated by STAI-Y self-administered questionary | before surgery (day 2_before) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score evaluated by analogue visual scale | evaluated by analogue visual scale (EVA 0 to 10) | at inclusion visit (day 1), before surgery (day 2_before), after surgery (day 2_after), 24 h after the surgery (day 3) | 
| sleep quality evaluated by EVA scale | evaluated by EVA scale (0 to 10) | day 2_before and the day 3 | 
| patient satisfaction score evaluated by EVA scale | evaluated by EVA scale (0 to 10) | day 3 | 
| analysis of salivary amylase | salivary amylase | day 1 and day2_before | 
| postoperative fatigue evaluated by EVA scale | evaluated by EVA scale (0 to 10) | day 3 | 
| Intraoperative morphine and hypnotics drugs Consumption | Consumption | day 3 | 
| Incidence of nausea and vomiting | Incidence | day 3 | 
| Score of pain measured by EVA scale | measured by EVA (0 to 10) | day 2_after, day 2_recovery room (at the end of recovery room) and Day 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Premedication/ Hypnosis/ Anxiety/Surgery