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Preoperative Hypnosis Versus Premedication in Gynecological Surgery (HYPNOGYN)

Primary Purpose

Gynecologic Disease, Anxiety Disease

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Alprazolam 0.5 mg
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecologic Disease focused on measuring Premedication/ Hypnosis/ Anxiety/Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Florence VialRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hypnosis group

premedication

Arm Description

Intervention: hypnosis session the eve of the surgery

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

Outcomes

Primary Outcome Measures

Preoperative Anxiety score evaluated by STAI-Y
evaluated by STAI-Y self-administered questionary

Secondary Outcome Measures

Anxiety score evaluated by analogue visual scale
evaluated by analogue visual scale (EVA 0 to 10)
sleep quality evaluated by EVA scale
evaluated by EVA scale (0 to 10)
patient satisfaction score evaluated by EVA scale
evaluated by EVA scale (0 to 10)
analysis of salivary amylase
salivary amylase
postoperative fatigue evaluated by EVA scale
evaluated by EVA scale (0 to 10)
Intraoperative morphine and hypnotics drugs Consumption
Consumption
Incidence of nausea and vomiting
Incidence
Score of pain measured by EVA scale
measured by EVA (0 to 10)

Full Information

First Posted
October 17, 2017
Last Updated
February 22, 2021
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03327506
Brief Title
Preoperative Hypnosis Versus Premedication in Gynecological Surgery
Acronym
HYPNOGYN
Official Title
Efficacity of Hypnosis Versus Premedication for the Management of Perioperative Anxiety in Gynecological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Disease, Anxiety Disease
Keywords
Premedication/ Hypnosis/ Anxiety/Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hypnosis group
Arm Type
Experimental
Arm Description
Intervention: hypnosis session the eve of the surgery
Arm Title
premedication
Arm Type
Active Comparator
Arm Description
alprazolam 0,5 mg the eve and the morning of the surgery
Intervention Type
Drug
Intervention Name(s)
Alprazolam 0.5 mg
Other Intervention Name(s)
hypnosis
Intervention Description
alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session
Primary Outcome Measure Information:
Title
Preoperative Anxiety score evaluated by STAI-Y
Description
evaluated by STAI-Y self-administered questionary
Time Frame
before surgery (day 2_before)
Secondary Outcome Measure Information:
Title
Anxiety score evaluated by analogue visual scale
Description
evaluated by analogue visual scale (EVA 0 to 10)
Time Frame
at inclusion visit (day 1), before surgery (day 2_before), after surgery (day 2_after), 24 h after the surgery (day 3)
Title
sleep quality evaluated by EVA scale
Description
evaluated by EVA scale (0 to 10)
Time Frame
day 2_before and the day 3
Title
patient satisfaction score evaluated by EVA scale
Description
evaluated by EVA scale (0 to 10)
Time Frame
day 3
Title
analysis of salivary amylase
Description
salivary amylase
Time Frame
day 1 and day2_before
Title
postoperative fatigue evaluated by EVA scale
Description
evaluated by EVA scale (0 to 10)
Time Frame
day 3
Title
Intraoperative morphine and hypnotics drugs Consumption
Description
Consumption
Time Frame
day 3
Title
Incidence of nausea and vomiting
Description
Incidence
Time Frame
day 3
Title
Score of pain measured by EVA scale
Description
measured by EVA (0 to 10)
Time Frame
day 2_after, day 2_recovery room (at the end of recovery room) and Day 3

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
florence vial
Phone
0033610405237
Email
f.vial@chu-nancy.fr
Facility Information:
Facility Name
Florence Vial
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FLORENCE VIAL, DR
Phone
0033383944490
Email
f.vial@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
FLORENCE vial, dr

12. IPD Sharing Statement

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Preoperative Hypnosis Versus Premedication in Gynecological Surgery

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