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

Central Hospital, Nancy, France1 site in 1 country128 target enrollmentNovember 27, 2018

ConditionsGynecologic Disease Anxiety Disease

InterventionsAlprazolam 0.5 mg

DrugsAlprazolam 0.5 mg

Overview

Phase: Phase 4
Intervention: Alprazolam 0.5 mg
Conditions: Gynecologic Disease
Sponsor: Central Hospital, Nancy, France
Enrollment: 128
Locations: 1
Primary Endpoint: Preoperative Anxiety score evaluated by STAI-Y
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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®.

Registry

clinicaltrials.gov

Start Date

November 27, 2018

End Date

December 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Central Hospital, Nancy, France

Responsible Party

Sponsor

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

Arms & Interventions

hypnosis group

Intervention: hypnosis session the eve of the surgery

Intervention: Alprazolam 0.5 mg

premedication

alprazolam 0,5 mg the eve and the morning of the surgery

Intervention: Alprazolam 0.5 mg

Outcomes

Primary Outcomes

Preoperative Anxiety score evaluated by STAI-Y

Time Frame: before surgery (day 2_before)

evaluated by STAI-Y self-administered questionary

Secondary Outcomes

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