Preoperative Hypnosis Versus Premedication in Gynecological Surgery

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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®.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Hospital, Nancy, France
• Treatments: Alprazolam

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