An interventional study of Virtual reality headset and Standard Care (in control arm) in Orthopedic Procedure, Anesthesia and Sedation, sponsored by Centre Hospitalier Eure-Seine. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Centre Hospitalier Eure-Seine · Not applicable, Interventional, and Other
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.
Centre Hospitalier Eure-Seine is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Virtual reality headset
Participants in this group receive standard anesthetic and surgical care without the use of virtual reality.
Other: Standard Care (in control arm)
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
Participants in this group receive standard anesthetic and surgical care without the use of virtual reality
Comparison of sedation use rates between the experimental group and the control group (level 0 versus ≥1).
Proportion of patients who required sedation (at level ≥1) during regional anesthesia or surgery, compared to those who did not receive sedation (level 0). Sedation levels are defined according to a standardized scale.
Time frame: Intraoperative period (from arrival in the operating room to the end of surgery)
Mean age of patients
Mean age of patient in each group at baseline
Time frame: Baseline (before anesthesia consultation or at inclusion)
Sex distribution
Number of male and female patients in each group
Time frame: Baseline (before anesthesia consultation or at inclusion)
type of surgery
Distribution of types of surgery performed in each group
Time frame: Baseline (before anesthesia consultation or at inclusion)
ASA score distribution
Distribution of ASA physical status scores among patients in each group
Time frame: Baseline (before anesthesia consultation or at inclusion)
Plan to share: No
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Centre Hospitalier Eure-Seine