Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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®.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypnosis group | Experimental | Intervention: hypnosis session the eve of the surgery |
|
| premedication | Active Comparator | alprazolam 0,5 mg the eve and the morning of the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprazolam 0.5 mg | Drug | alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative Anxiety score evaluated by STAI-Y | evaluated by STAI-Y self-administered questionary | before surgery (day 2_before) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| sleep quality evaluated by EVA scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| florence vial | Contact | 0033610405237 | f.vial@chu-nancy.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florence Vial | Recruiting | Nancy | 54000 | France |
Not provided
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000525 | Alprazolam |
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
evaluated by EVA scale (0 to 10) |
| day 2_before and the day 3 |
| patient satisfaction score evaluated by EVA scale | evaluated by EVA scale (0 to 10) | day 3 |
| analysis of salivary amylase | salivary amylase | day 1 and day2_before |
| postoperative fatigue evaluated by EVA scale | evaluated by EVA scale (0 to 10) | day 3 |
| Intraoperative morphine and hypnotics drugs Consumption | Consumption | day 3 |
| Incidence of nausea and vomiting | Incidence | day 3 |
| 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 |
| D006571 | Heterocyclic Compounds |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |