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This study evaluate the interest of Virtual Reality to reduce the preoperative anxiety in patients who undergo to ambulatory surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | General routine care. This group will undergo to ambulatory surgery without preoperative virtual reality session. Will be applied the usual treatment to reduce preoperative anxiety. |
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| Virtual reality group | Experimental | Virtual Reality. This group will undergo to 20 min virtual reality before ambulatory surgery. In addition to virtual reality session, will be applied the usual treatment to reduce preoperative anxiety, after virtual reality, if necessary. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality session | Device | The 20-minute virtual reality session, in the outpatient department before surgery, immerses the patient in calm environments combined with music therapy and breathing exercises to relax and reduce anxiety. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Anxiety | Measured by State-Trait Anxiety Inventory (STAI YA) . The scale includes twenty items.. Each question is assigned 1 to 4 points, giving a score of 20 (low anxiety) to 80 points (high anxiety) | D0 : baseline and right before going to surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of milligrams of midazolam administered | Comparison of midazolam premedication to reduce preoperative anxiety between control group and virtual reality group. | D0 (before surgery) |
| Percentage of patients with intraoperative remifentanil required |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud FRIGGERI | Hospices Civils de Lyon - Centre Hospitalier Lyon Sud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Lyon Sud | Pierre-Bénite | France |
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| State Trait Anxiety Inventory | Other | The State Trait Anxiety Inventory (State anxiety) is a questionnaire given to adults that shows how strong a person's feelings of anxiety are "right now, just now". The score is measured on arrival in the outpatient department and just before going into the intervention room (= after the virtual reality session for the experimental group) |
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| Virtual Reality Satisfaction Score | Other | Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session |
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| Perioperative care satisfaction score | Other | Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care |
|
Comparison in term of Number of case where the utilisation of remifentanil was necessary in peroperative between control group and virtual reality group. |
| D0 (during surgery) |
| Pain score | Pain assessment with numerical scale from 0 (low) to 10(high) | D0 (after surgery) |
| Morphine dose used | Comparison of morphine dose used in recovery room between control group and virtual reality group | D0 (after surgery in recovery room) |
| Perioperative care satisfaction score | Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care. 5 answer possible :Very satisfied - satisfied- Neither satisfied nor unsatisfied- Unsatisfied - Very unsatisfied | through study completion, 1 day |
| Nature and severity of adverse events | Comparison of adverse event during hospitalization between control group and virtual reality group | through study completion, 1 day |
| Adverse events related to the virtual reality session | Nature and severity of adverse events related to the virtual reality session | through study completion, 1 day |
| Virtual Reality Satisfaction Score | Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session. 5 items scored from 0 (low) to 10 (high) | through study completion, 1 day |
| Experience of the caregiver | Experience of the caregiver concerning the implementation of virtual reality in the outpatient department before surgery . 2 items scored from 0 (low) to 10 (high) | D0 (before surgery) |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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