Virtual Reality in Awake Surgery : Pilot Study VIRAS

Not Applicable

Recruiting

• Conditions: Surgery
• Interventions: Other: Training session with the virtual reality mask; Other: Monitoring of the device; Other: Acceptability of the device; Other: Patient state of anxiety

• Registration Number: NCT05151822
• Lead Sponsor: University Hospital, Brest

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-26
• Study First Posted: 2021-12-09
• Study Start: 2022-05-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-11
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual reality mask	Training session with the virtual reality mask	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
Virtual reality mask	Monitoring of the device	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
Virtual reality mask	Acceptability of the device	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
Virtual reality mask	Patient state of anxiety	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

Primary Outcome Measures

Name	Time	Method
Tolerance of minimum 1 hour of the virtual reality mask (realization, by the patient, of a series of of language or neuropsychological tests)	1 Day	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.

Secondary Outcome Measures

Name	Time	Method
Device-related adverse event	1 Day	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.
Withdrawal of the device	1 Day	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)
Device tolerance for the patient	1 Day	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.
Device tolerance for the medical staff	1 Day	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
Patient state of anxiety	1 Day	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.

Trial Locations

Locations (1)

Pr SEIZEUR Romuald; 🇫🇷 Brest, France