Virtual Reality in Awake Surgery : Pilot Study VIRAS

Study Overview
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Brief Summary
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The virtual reality mask is a tool likely to improve the conditions for performing awake surgery: by improving tolerance for the patient, by improving ergonomics in the operating room. In order to control the risks as well as possible, the investigators propose to test the equipment on patients who will undergo orthopedic surgery under local anesthesia at the hospital of Brest: the patients operated in orthopedics under local anesthesia are immobile during the procedure. This target population will allow an immersion of the equipment in the operating room, with an awake patient, during a short time (on average 1 hour of intervention) and for a technically light interventional procedure.

Official Title
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Virtual Reality in Awake Surgery : Pilot Study VIRAS

Conditions
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Surgery

Intervention / Treatment
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* Other: Training session with the virtual reality mask
* Other: Monitoring of the device
* Other: Acceptability of the device
* Other: Patient state of anxiety


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Major subject Consent for the study Patients eligible for orthopedic surgery with local anesthetic block Estimated duration of the Orthopedic surgery of minimum 1 hour Exclusion Criteria : Age < 18 years, Age > 75 years, Known central neurological pathology/cognitive impairment, Mini-Mental State examination (MMSe) < 23 if no school certificate, < 27 if school certificate, History of vertigo, Claustrophobia, Visual deficit not compatible with the use of the virtual reality mask, Contraindication to surgery, Outpatient treatment, Refusal or inability to consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality mask<br>Realization of the following examinations with virtual reality mask : Training session Acceptability of the device before and after surgery Monitoring of the device during surgery | Other: Training session with the virtual reality mask<br>* Patients will have a training session with the virtual reality mask, the day before surgery. The training consists in the realization, by the patient, of a series of language or neuropsychological tests and evaluation of the acceptability of the device by the patient with Visual Analog Scale (device tolerance from 0 (intolerable) to 10 (completely tolerated)).<br>Other: Monitoring of the device<br>* In the operating room : installation and per-operative monitoring of the device. If the device was removed, the list of device side effects or surgery-related adverse events that was required discontinuation of the device will be established.<br>Other: Acceptability of the device<br>* After the surgery: evaluation of the acceptability of the device by the patient with Visual Analog Scale (device tolerance from 0 (intolerable) to 10 (completely tolerated))<br>Other: Patient state of anxiety<br>* Assessing patient's state of anxiety with the State-Trait Anxiety Inventory (STAI) after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of minimum 1 hour of the virtual reality mask (realization, by the patient, of a series of of language or neuropsychological tests) | Study the tolerance of the virtual reality mask on patients in the operating room for orthopedic surgery under loco-regional anesthesia. The mask must be maintained during the testing (minimum 1 hour). The testing consists in the realization, by the patient, of a series of language or neuropsychological tests predefined during the preoperative assessment. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related adverse event | List of device-related adverse events with Simulator Sickness Questionnaire (SSQ). SSQ quantified virtual reality mask sickness with 16 questions on a self-report basis. | 1 Day | 
| Withdrawal of the device | List of adverse events that required removal of the device (device side effects or surgery-related adverse events that may require discontinuation of the device) | 1 Day | 
| Device tolerance for the patient | Visual Analog Scale (VAS) of device tolerance from 0 (intolerable) to 10 (completely tolerated), immediately after the training session and at the end of the procedure. | 1 Day | 
| Device tolerance for the medical staff | Visual Analog Scale (VAS) of device tolerance from 0 (intolerable) to 10 (completely tolerated), to a representative of each profession present in the operating room during the procedure (anesthetist, surgeon, nurse), at the end of the procedure | 1 Day | 
| Patient state of anxiety | Assessing patient's state of anxiety with the STAI. The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety. | 1 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Awake surgery