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HYPNOGYN: Preoperative Hypnosis Versus Premedication in Gynecological Surgery

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT03327506
Collaborator
(none)
128
Enrollment
1
Location
2
Arms
36.1
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

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®.

Condition or Disease Intervention/Treatment Phase
  • Drug: Alprazolam 0.5 mg
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacity of Hypnosis Versus Premedication for the Management of Perioperative Anxiety in Gynecological Surgery
Actual Study Start Date :
Nov 27, 2018
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Preoperative Anxiety score evaluated by STAI-Y [before surgery (day 2_before)]

      evaluated by STAI-Y self-administered questionary

    Secondary Outcome Measures

    1. 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)

    2. sleep quality evaluated by EVA scale [day 2_before and the day 3]

      evaluated by EVA scale (0 to 10)

    3. patient satisfaction score evaluated by EVA scale [day 3]

      evaluated by EVA scale (0 to 10)

    4. analysis of salivary amylase [day 1 and day2_before]

      salivary amylase

    5. postoperative fatigue evaluated by EVA scale [day 3]

      evaluated by EVA scale (0 to 10)

    6. Intraoperative morphine and hypnotics drugs Consumption [day 3]

      Consumption

    7. Incidence of nausea and vomiting [day 3]

      Incidence

    8. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Florence Vial Nancy France 54000

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT03327506
    Other Study ID Numbers:
    • 2017-002112-13
    First Posted:
    Oct 31, 2017
    Last Update Posted:
    Feb 23, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Central Hospital, Nancy, France
    Premedication/ Hypnosis/ Anxiety/Surgery
    Additional relevant MeSH terms:
    Anxiety Disorders
    Alprazolam

    Study Results

    No Results Posted as of Feb 23, 2021