Clinical Research Directory
Browse clinical research sites, groups, and studies.
Virtual Reality in Awake Surgery : Pilot Study VIRAS
Sponsor: University Hospital, Brest
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.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-05-24
Completion Date
2026-02
Last Updated
2024-11-22
Healthy Volunteers
No
Conditions
Interventions
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)).
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.
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))
Patient state of anxiety
Assessing patient's state of anxiety with the State-Trait Anxiety Inventory (STAI) after surgery.
Locations (1)
Pr SEIZEUR Romuald
Brest, France