Preoperative Hypnosis Versus Premedication in Gynecological Surgery (HYPNOGYN)

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

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®.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Disease; Anxiety Disease
• Intervention / Treatment: Drug: Alprazolam 0.5 mg

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: florence vial; Phone Number: 0033610405237; Email: f.vial@chu-nancy.fr

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • Florence Vial
    • Contact: FLORENCE VIAL, DR; Phone Number: 0033383944490; Email: f.vial@chu-nancy.fr
    • Principal Investigator: FLORENCE vial, dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Premedication/ Hypnosis/ Anxiety/Surgery
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Alprazolam
• Other Study ID Numbers: 2017-002112-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No