NCT07013695

Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Centre Hospitalier Eure-Seine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The VIRTUALR study evaluates the effect of virtual reality combined with hypnosis on anxiety in patients undergoing orthopedic surgery under regional anesthesia. Patients are randomly assigned to two groups: one group receiving virtual reality and a control group without the device. Anxiety and satisfaction questionnaires are used to compare the two groups.

Conditions

• Orthopedic Procedure
• Anesthesia
• Sedation

Interventions

Type	Name	Description
DEVICE	Virtual reality headset	Patients in the intervention group receive a virtual reality session with a hypnotic purpose during surgery under regional anesthesia. The device consists of a virtual reality headset providing visual and auditory immersion in a calming environment, freely chosen by the patient. The session begins before the regional anesthesia is administered and may continue throughout the entire surgical procedure
OTHER	Standard Care (in control arm)	Participants in this group receive standard anesthetic and surgical care without the use of virtual reality

Timeline

• Start date: 2024-07-18
• Primary completion: 2025-07-17
• Completion: 2025-07-19
• First posted: 2025-06-10
• Last updated: 2025-06-10

Locations

1 site across 1 country: France