Preoperative Hypnosis Versus Premedication in Gynecological Surgery

Phase 4

• Conditions: Anxiety Disease; Gynecologic Disease
• Interventions: Drug: Alprazolam 0.5 mg

• Registration Number: NCT03327506
• Lead Sponsor: Central Hospital, Nancy, France

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®.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-10-31
• Study Start: 2018-11-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-23
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
premedication	Alprazolam 0.5 mg	alprazolam 0,5 mg the eve and the morning of the surgery
hypnosis group	Alprazolam 0.5 mg	Intervention: hypnosis session the eve of the surgery

Primary Outcome Measures

Name	Time	Method
Preoperative Anxiety score evaluated by STAI-Y	before surgery (day 2_before)	evaluated by STAI-Y self-administered questionary

Secondary Outcome Measures

Name	Time	Method
sleep quality evaluated by EVA scale	day 2_before and the day 3	evaluated by EVA scale (0 to 10)
postoperative fatigue evaluated by EVA scale	day 3	evaluated by EVA scale (0 to 10)
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)	evaluated by analogue visual scale (EVA 0 to 10)
patient satisfaction score evaluated by EVA scale	day 3	evaluated by EVA scale (0 to 10)
Score of pain measured by EVA scale	day 2_after, day 2_recovery room (at the end of recovery room) and Day 3	measured by EVA (0 to 10)
analysis of salivary amylase	day 1 and day2_before	salivary amylase
Intraoperative morphine and hypnotics drugs Consumption	day 3	Consumption
Incidence of nausea and vomiting	day 3	Incidence

Trial Locations

Locations (1)

Florence Vial; 🇫🇷 Nancy, France