Preoperative Hypnosis Versus Premedication in Gynecological Surgery

  • STATUS
    Recruiting
  • End date
    Dec 3, 2021
  • participants needed
    128
  • sponsor
    Central Hospital, Nancy, France
Updated on 3 March 2021

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.

Details
Condition Female Genital Diseases, Gynecological Infections, gynecologic disease, gynecologic disorders, gynecological disorder, Anxiety Disease
Treatment Alprazolam 0.5 mg
Clinical Study IdentifierNCT03327506
SponsorCentral Hospital, Nancy, France
Last Modified on3 March 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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