Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia

Study Overview
=================
Brief Summary
-----------------
This prospective study aims to evaluate whether the implementation of a virtual reality hypnosedation (VRH)protocol reduces preoperative anxiety and increases patient comfort before, during, and after outpatient foot surgery.

Detailed Description
-----------------
This prospective study aims to evaluate whether the implementation of a virtual reality hypnosedation (VRH) protocol reduces preoperative anxiety and increases patient comfort before, during, and after outpatient foot surgery. The investigators hope to demonstrate a reduction in anxiety, improved postoperative experience and functional recovery according to currently validated scores measuring preoperative and postoperative recovery, anxiety and stress, and experience during a regional anesthesia technique. The investigators expect that VRH will be more effective than VR alone and conventional pharmacological sedation in reducing preoperative anxiety and in improving experience and functional recovery. If the hypothesis is correct, the investigators could propose to integrate this protocol as a first line in the ambulatory management of elective foot surgery.

Official Title
-----------------
Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia: a Randomized Clinical Trial.

Conditions
-----------------
Foot Deformities, Regional Anesthesia Morbidity, Valgus; Hallux, Analgesia

Intervention / Treatment
-----------------
* Device: Hypnosedation
* Drug: Midazolam injection
* Device: Virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patients, classified as ASA 1-2-3, admitted for foot surgery (metatarsophalangeal arthrodesis or hallux valgus cure), under peripheral locoregional anesthesia (sciatic nerve block at popliteal level). Exclusion Criteria: pregnant women patients with peripheral neuropathy or other severe neurological pathology allergy or contraindication to local anesthetics or benzodiazepines chronic renal failure or severe hepatic failure major hemostasis disorders severe vision or hearing problems that would render the VR and VRH device useless or unusable, and patient contraindication or refusal to use the VRH headset, such as claustrophobia or kinesiophobia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Randomized Clinical Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VR<br>Patients in the VR group (19 patients) will receive VR alone without hypnosedation. The VR headset will be used on these patients without an external voice or device allowing hypnosis. The VR module used will be Silva, i.e. a scenario of a walk in the forest through the 4 seasons. | Device: Virtual reality<br>* Only virtual reality without a hypnosedation session. The virtual reality headset will be used on these patients without external voice or hypnosis device. The virtual reality module used will be Silva, i.e. a scenario of a walk in the forest through the 4 seasons.<br>|
| Experimental: VRH<br>The patients in the VRH group (19 patients) will benefit from a hypnosedation session with a VRH headset during the local anesthesia technique and during the surgery (approximately 60 minutes). The VRH module used will be Silva, i.e. the same scenario of a walk in the forest through the 4 seasons with a voice accompanying the hypnosis session. | Device: Hypnosedation<br>* Hypnosedation session with a virtual reality headset during the regional anesthesia technique and during the surgery (approximately 60 minutes). The VRH module used will be Silva, i.e. the same scenario of a walk in the forest through the 4 seasons with a voice accompanying the hypnosis session.<br>|
| Active Comparator: C<br>Patients in group C (control group, 19 patients) will receive only midazolam-based pharmacological sedation. This will be administered with intermittent boluses of 1 mg until patient comfort and sedation on the Richmond analgo-sedation scale (RASS) of -3 (response to verbal stimulus) is achieved. | Drug: Midazolam injection<br>* Midazolam intravenous injection 1 mg until RASS -3<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Evaluation du Vecu de l'Anesthesie LocoRegionale) EVAN-LR | The primary endpoint will be the EVAN-LR score as a measure of intraoperative experience. EVAN-LR: a 0-100 scale, with 100 indicating the best possible level of satisfaction and 0 the worst. | 4 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Numeric rating scale (NRS) (0 to 10) for pre- and postoperative anxiety | 5 minutes after the end of the surgery | 
| Quality of Recovery- 15 items (QoR-15) | Assessment of the QoR-15 score on postoperative functional recovery and the variation in time between the day before surgery, the day after and 3 days after surgery | 1 day before, 1 and 3 day after surgery | 
| Length of surgery | Length of surgery procedure in minutes | 5 minutes after the end of the surgery | 
| Complications | The occurrence of complications related to the techniques used | 6 hours after surgery | 
| VRH complications | The occurrence of side effects related to virtual reality (nausea, paradoxical anxiety, dizziness, etc.) | 6 hours after surgery | 
| Time perception | Perception of the duration of the surgery during the VRH. | 5 minutes after the end of the surgery | 
| Surgeon satisfaction | Surgeon satisfaction on a numeric rating scale from 0 to 10 | 5 minutes after the end of the surgery | 
| Dissociation | The Numeric rating scale (NRS) (0-10) dissociation for the assessment of dissociation during the surgery | 5 minutes after the end of the surgery |