Anxiety Disease, Gynecologic Disease
Conditions
Keywords
Premedication/ Hypnosis/ Anxiety/Surgery
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®.
Interventions
alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative Anxiety score evaluated by STAI-Y | before surgery (day 2_before) | evaluated by STAI-Y self-administered questionary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sleep quality evaluated by EVA scale | day 2_before and the day 3 | evaluated by EVA scale (0 to 10) |
| patient satisfaction score evaluated by EVA scale | day 3 | evaluated by EVA scale (0 to 10) |
| analysis of salivary amylase | day 1 and day2_before | salivary amylase |
| 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) |
| Intraoperative morphine and hypnotics drugs Consumption | day 3 | Consumption |
| Incidence of nausea and vomiting | day 3 | Incidence |
| 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) |
| postoperative fatigue evaluated by EVA scale | day 3 | evaluated by EVA scale (0 to 10) |
Countries
France
Contacts
Primary Contactflorence vial
Outcome results
None listed