Actively Recruiting
Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery
Led by Centre Hospitalier Eure-Seine · Updated on 2025-06-10
164
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates how virtual reality combined with hypnosis affects anxiety in patients undergoing scheduled orthopedic surgery with regional anesthesia. It compares anxiety levels and patient satisfaction between those using virtual reality and those receiving standard care. The study is randomized and seeks to understand if virtual reality can influence sedation needs during surgery. Participants are randomly assigned to one of two groups. One group experiences a virtual reality session with hypnotic content through a headset, starting before regional anesthesia and possibly continuing throughout surgery. The other group receives standard anesthetic and surgical care without virtual reality. The study is conducted during the intraoperative period. During the study, researchers monitor sedation use from arrival in the operating room until surgery ends. They also collect baseline data such as patients' age, sex, type of surgery, and ASA score. Anxiety and satisfaction questionnaires are used to compare groups. The total participation timeline covers the surgical procedure and associated assessments.
CONDITIONS
Brief Title
Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo scheduled orthopedic surgery with regional anesthesia. Those in the virtual reality group experience a virtual reality session starting before anesthesia and continuing through surgery, while the control group receives standard care without virtual reality.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Eure-Seine
Évreux, France, 27000
Actively Recruiting
Research Team
L
Lydia BEN BEKKOU
D
Dihia AIDENE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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