Gynecologic Disease Clinical Trial
— HYPNOGYNOfficial title:
Efficacity of Hypnosis Versus Premedication for the Management of Perioperative Anxiety in Gynecological Surgery
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®.
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 AlprazolamĀ® (including undocumented) - Prohibition conditions to AlprazolamĀ®: 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 |
Country | Name | City | State |
---|---|---|---|
France | Florence Vial | Nancy |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
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 |
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