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

Centre Hospitalier Eure-Seine

Status: Enrolling

Conditions: Sedation; Orthopedic Procedure; Anesthesia

Treatments: Other: Standard Care (in control arm); Device: Virtual reality headset

Study type: Interventional

Funder types: Other

Identifiers

NCT07013695

2022-A00055-38

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Patient affiliated with or benefiting from a social security system
• Patient aged 18 years or older
• Patient requiring regional anesthesia for scheduled orthopedic surgery of the upper or lower limb

Exclusion criteria

• Patient refusal to participate in the study
• Device interfering with the surgical or anesthetic procedure
• Premedication before arrival in the operating room
• Psychiatric or cognitive disorders, communication disorders
• Patient unable to understand the study (language barrier, psychological issues)
• Emergency surgery

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups, including a placebo group

virtual reality group

Active Comparator group

Description:

Participants in this group receive a virtual reality session with a hypnotic objective during surgery performed under regional anesthesia. The device consists of a virtual reality headset offering immersive visual and auditory content in a calming environment chosen by the participant. The session begins before the administration of regional anesthesia and may continue throughout the surgical procedure.

Treatment:

Device: Virtual reality headset

Control Group

Placebo Comparator group

Description:

Participants in this group receive standard anesthetic and surgical care without the use of virtual reality.

Treatment:

Other: Standard Care (in control arm)