Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery

Conditions
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Anxiety

Intervention / Treatment
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* Device: Virtual reality session
* Other: State Trait Anxiety Inventory
* Other: Virtual Reality Satisfaction Score
* Other: Perioperative care satisfaction score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II (classification of the American Society of Anesthesiologists). Ambulatory surgery scheduled Score STAI YA > 45 Affiliated to a social security Understanding the study and signing the informed consent Exclusion Criteria: Contraindications for Midazolam Patients with disorders not compatible with virtual reality: severe cognitive or psychiatric disorders, blindness, claustrophobia, epilepsy Patient with a pacemaker of others implantable medical devices patient with burns or wounds on the upper face or scalp Visual hallucinations Contagious disease by air or indirect contact Person unable to express their consent Minor patient or patient under curatorship or guardianship patient participating in another interventional clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>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. | Other: State Trait Anxiety Inventory<br>* 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)<br>Other: Perioperative care satisfaction score<br>* Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care<br>|
| Experimental: Virtual reality group<br>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. | Device: Virtual reality session<br>* 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.<br>Other: State Trait Anxiety Inventory<br>* 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)<br>Other: Virtual Reality Satisfaction Score<br>* Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session<br>Other: Perioperative care satisfaction score<br>* Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, preoperative anxiety, anxiety