Virtual Reality (VR) to Reduce Preoperative Anxiety.

Study Overview
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Brief Summary
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Most patients awaiting surgery show significant anxiety score which can be influenced by the fear of anesthesia or surgery but also by the context of care. These anxious patients will have more postoperative complications and can also develop chronic pain. The Virtual reality AQUA module induces hypnosis and is specially designed to reduce anxiety. The purpose of the study is to examine the effect of a virtual reality session on preoperative anxiety.

Official Title
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The Impact of Induced Hypnosis by Virtual Reality AQUA Module on Preoperative Anxiety.

Conditions
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Preoperative

Intervention / Treatment
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* Device: Virtual reality (VR) session with AQUA module


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing scheduled orthopedic surgery with loco-regional anesthesia at Saint-Luc Hospital. Patients not following long-term psychotherapeutic treatment Patients not taking psychotropic medication free, informed and written consent signed by the investigator and the patient before the procedure. Exclusion Criteria: patient not speaking French Patients with long-term psychotherapeutic treatment Patients taking psychotropic drugs patient blind and deaf

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Preoperative virtual reality session<br>Amsterdam Anxiety score recorded before VR session is followed by a 15 min VR session and finally Amsterdam Anxiety score is recorded after VR session | Device: Virtual reality (VR) session with AQUA module<br>* A device with virtual reality is given to the patients with a film of 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Amsterdam preoperative anxiety and information score (APAIS) after VR session | The Amsterdam preoperative anxiety and information (APAIS) scale is a 6-items questionnaire. Each item is scored from 1(not at all) to 5(extremely). 4 items assess anxiety (patient with a score >or = to 11 is considered very anxious), 2 items assess the desire for information (patient with a score > 8 is considered very anxious because there is a corelation between need for informa tion and anxiety). The score ranges from 6 (no anxious) to 30 (highly anxious). | 5 minutes after virtual reality session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation du Vécu de l'ANesthésie - LocoRégionale) EVAN-LR satisfaction score | Evaluation du Vécu de l'Anesthésie LocoRégionale (EVAN-LR) is a tool assessing patient satisfaction within the perioperative period surrounding regional anesthesia. The EVAN-LR comprises 19 items, structured in a global index and five dimensions: Attention, Information, Discomfort, Waiting, and Pain. Each item is scored from 1(not at all) to 5(extremely). The score ranges from 18(no satisfied) to 95 (highly satisfied). | 2 hours after VR session (in the recovery room, after surgery) | 
| Change of Visual Analog Score (VAS) anxiety score after VR session | score between 0 ( no anxious) and 10 (highly anxious) | 5 minutes after the virtual reality session |