Ireland
--:--IST
Recruiting Not applicable

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

NCT07013695 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Eure-Seine
Phase
Not applicable
Started
2024-07-18
Last updated
2025-06-10

Condition(s) studied

Orthopedic ProcedureAnesthesiaSedation

Investigational drug(s) / intervention(s)

Virtual reality headsetStandard Care (in control arm)

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

Standard Care (in control arm): Participants in this group receive standard anesthetic and surgical care without the use of virtual reality

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Comparison of sedation use rates between the experimental group and the control group (level 0 versus ≥1). — Intraoperative period (from arrival in the operating room to the end of surgery)
    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.

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier Eure-Seine Évreux France Recruiting

More Centre Hospitalier Eure-Seine trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07013695 on ClinicalTrials.gov ↗ ← All trials in France