Actively Recruiting
Comparison of Two Relaxation Strategies: PSiO Glasses, Virtual Reality Hypnosis, and No Relaxation Tool for Preoperative Anxiety in Adult Orthopedic Patients
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2026-04-29
632
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate ways to reduce preoperative anxiety in adult orthopedic patients undergoing surgery with general anesthesia. High anxiety before surgery can lead to poor sleep, increased pain after surgery, and more use of painkillers. Since there are no current standard recommendations to prevent this anxiety, the study compares two relaxation methods to help improve patient well-being before their operation. Participants are randomly assigned to one of three groups: a 20-minute virtual reality hypnosis session using the HypnoVR headset, a 20-minute relaxation session with PSiO glasses that provide light therapy and music, or a 20-minute waiting period without any relaxation tool. Both devices aim to induce relaxation through visual and auditory experiences tailored to the patient. During the study, researchers will monitor changes in anxiety using the APAIS scale, and track physiological signs such as heart rate, respiratory rate, blood pressure, and oxygen levels. They will also record the amount of anesthesia used, time spent in the recovery room, and pain levels. These assessments occur within one hour after the relaxation or waiting session to evaluate the effects on preoperative anxiety and related outcomes.
CONDITIONS
Brief Title
Comparison of Two Relaxation Strategies Between Glasses, Virtual Reality Headset, and Without Relaxation Tool, in the Anxiety Preoperative of Orthopedic Adult Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient treated at the UAC D0
- Orthopedic patient, mainly undergoing arthroplasty
- Scheduled for anesthesia with general anesthesia
- Age over 18 years without cognitive impairment as judged by the investigator
- Signed free and informed consent
- Affiliated to a social security scheme
You will not qualify if you...
- Deafness preventing perception and understanding of sounds
- Visual impairment preventing watching and understanding videos
- Does not understand spoken, written, or read French
- History of epilepsy
- History of migraine or headache triggered by virtual reality headset use
- History of dizziness triggered by images such as films or video games
- Untreated dry eye disease
- Psychiatric diseases or disorders incompatible with the study as judged by the investigator
- Pregnant, giving birth, or breastfeeding
- Under guardianship, curatorship, judicial protection, or deprived of public rights
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 - 20 minutes
Participants receive a 20-minute session using either the HypnoVR virtual reality hypnosis, PSiO glasses relaxation, or no relaxation tool before their orthopedic surgery to manage preoperative anxiety.
1 visit (in-person)
Duration - 1 hour
Participants are monitored for anxiety levels and vital signs including heart rate, respiratory rate, blood pressure, and oxygen saturation for 1 hour after the relaxation session.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Amiens University Hospital
Amiens, Picardie, France, 80054
Actively Recruiting
Research Team
F
François JOACHIM, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here