Using Virtual Reality to Prevent Pre-operative Anxiety in Ambulatory Surgery Patients

Study Overview
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Brief Summary
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The primary objective is to evaluate the impact on pre-operative anxiety management of using the virtual reality mask for surgery of hallux valgus.

Detailed Description
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As secondary objectives, the study aims to evaluate post-operative analgesic according to non-drug pre-operative hypnosis, measured by reduction in analgesic intake, and by evaluate of pain; to evaluate factors which permitting discharge rapidly from hospital in case of hypnosis with virtual reality.

Official Title
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Hypnosis Mask in Pre-operative Anxiety Management in Ambulatory Surgery Patients: Using Virtual Reality

Conditions
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Hallux Valgus, Surgery

Intervention / Treatment
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* Device: Mask-wearing hypnosis
* Other: Without hypnosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ≥ 18 years; Autonomous patient living at home; Affiliated to a social security scheme; Informed consent signed by patient; Patient will undergo a planned ambulatory surgery for hallux valgus. Exclusion Criteria: Inability to understand STAI-A questionnaire; Patient refusal; Patient underwent a bilateral surgery; Patient judicial decision; Covered by french AME health system.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypnosis group<br>Mask-wearing as hypnosis method for patients in this arm. | Device: Mask-wearing hypnosis<br>* Virtual mask will be worn by patients before and during surgery of Hallux valgus to realize hypnosis. Virtual mask with 2 types of voice: female voice and male voice. Several types of image or music to choice by patient.<br>|
| Sham Comparator: comparator group<br>No hypnosis for patients in this arm. | Other: Without hypnosis<br>* No hypnosis during surgery of Hallux valgus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety assessment at baseline | The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels. | baseline, pre-intervention | 
| Anxiety assessment after the surgery | The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels. | immediately after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic taken | Dose of analgesic taken will be added up. | at the end of study, an average of 1 day | 
| Duration of stay | Duration of stay before discharge of hospital. | at the end of study, an average of 1 day | 
| Pain assessment | EVA score, a french auto evaluation tool will be used for pain. | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hallux valgus, hypnosis, pre-operative anxiety, surgery