Preoperative Hypnosis Versus Premedication in Gynecological Surgery (HYPNOGYN)

Central Hospital, Nancy, France

Status and phase: Unknown; Phase 4

Conditions: Anxiety Disease; Gynecologic Disease

Treatments: Drug: Alprazolam 0.5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03327506

2017-002112-13

Details and patient eligibility

About

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®.

Enrollment: 128 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

hypnosis group

Experimental group

Description:

Intervention: hypnosis session the eve of the surgery

Treatment:

Drug: Alprazolam 0.5 mg

premedication

Active Comparator group

Description:

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

Treatment:

Drug: Alprazolam 0.5 mg