Virtual Reality Hypnosis in Total Knee Arthroplasty Under Spinal Anesthesia

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 15, 2023

Primary Completion Date

August 3, 2023

Study Completion Date

August 3, 2023

Conditions
Arthroplasty ComplicationsKnee OsteoarthritisAnesthesia ComplicationHypnotic; Anxiety DisorderSedation Complication
Interventions
DEVICE

VRH

The VR headset and headphones will be placed on patients after the spinal anesthesia, once the patient is positioned and the surgical drapes installed. Patients will then undergo a 120-minute Digital Sedation™ program (Aqua+© 120 Version 1.1 or subsequent version, Oncomfort SA, Waver, Belgium). They will experience an underwater experience while listening to hypnotic script designed to induce a change in state of consciousness, increasing parasympathetic system tone and relaxation response, and reducing the perception of painful stimuli. While the session is running, HCPs can see what is projected into the VRH headset on their Sedakit's X2 controller (i.e. the tablet connected to the glasses).

DRUG

Midazolam sedation

During the procedure, the patient in the control group receives pharmacological sedation, which is the standard of care currently practiced. Such sedation allows intraoperative anxiolysis, which is constantly required by patients in order to dissociate from their surroundings. Recall that total knee replacement surgery is extremely noisy, and the surrounding environment is itself an anxiety-provoking factor for the patient. Light to moderate, intraoperative sedation is carried out by intermittent boluses of midazolam 1 mg IV. Boluses are given every 5 minutes until a sedation level of -2 or -3 on the RASS (Richmond Agitation-Sedation Scale) scale is reached.

Trial Locations (1)

4000

CHU de Liège, Liège

All Listed Sponsors
lead

University of Liege

OTHER