NCT05151822

Virtual Reality in Awake Surgery : Pilot Study VIRAS

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgery

Interventions

Type	Name	Description
OTHER	Training session with the virtual reality mask	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)).
OTHER	Monitoring of the device	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.
OTHER	Acceptability of the device	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))
OTHER	Patient state of anxiety	Assessing patient's state of anxiety with the State-Trait Anxiety Inventory (STAI) after surgery.

Timeline

• Start date: 2022-05-24
• Primary completion: 2025-11-01
• Completion: 2026-02-01
• First posted: 2021-12-09
• Last updated: 2024-11-22

Locations

1 site across 1 country: France