Preoperative Hypnosis Versus Premedication in Gynecological Surgery

Gynecologic Disease Clinical Trial

— HYPNOGYN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03327506
• Other study ID #: 2017-002112-13
• Status: Recruiting
• Phase: Phase 4
• Start date: November 27, 2018
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Central Hospital, Nancy, France
• Contact: florence vial
• Phone: 0033610405237
• Email: f.vial[@]chu-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disease
• Anxiety Disorders
• Gynecologic Disease

Intervention

Drug:
• Alprazolam 0.5 mg
alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session

Locations

Country	Name	City	State
France	Florence Vial	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative Anxiety score evaluated by STAI-Y	evaluated by STAI-Y self-administered questionary	before surgery (day 2_before)
Secondary	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)
Secondary	sleep quality evaluated by EVA scale	evaluated by EVA scale (0 to 10)	day 2_before and the day 3
Secondary	patient satisfaction score evaluated by EVA scale	evaluated by EVA scale (0 to 10)	day 3
Secondary	analysis of salivary amylase	salivary amylase	day 1 and day2_before
Secondary	postoperative fatigue evaluated by EVA scale	evaluated by EVA scale (0 to 10)	day 3
Secondary	Intraoperative morphine and hypnotics drugs Consumption	Consumption	day 3
Secondary	Incidence of nausea and vomiting	Incidence	day 3
Secondary	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