Comparing VR hypnosis, PSiO relaxation glasses, and no relaxation tool to reduce anxiety before orthopedic surgery
Comparison of Two Relaxation Strategies Between Glasses, Virtual Reality Headset, and Without Relaxation Tool, in the Anxiety Preoperative of Orthopedic Adult Patients
This project tests whether virtual reality hypnosis, PSiO relaxation glasses, or no relaxation tool best reduces anxiety in adults before orthopedic surgery under general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 632 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens, Picardie) |
| Trial ID | NCT07557550 on ClinicalTrials.gov |
What this trial studies
Preoperative anxiety is common in adults undergoing orthopedic surgery and can worsen sleep, increase postoperative pain, and raise analgesic needs. In this interventional study at Amiens University Hospital, eligible adult orthopedic patients are assigned to receive HypnoVR, PSiO relaxation glasses, or no relaxation tool prior to anesthesia. The trial measures preoperative anxiety and related outcomes such as sleep quality and early postoperative pain and analgesic use. The goal is to compare the immediate calming effects of the two devices versus usual care in a real clinical preoperative setting.
Who should consider this trial
Good fit: Adults (>18) treated at the UAC D0 for orthopedic procedures (mainly arthroplasty) who will receive general anesthesia, can consent, speak French, and have no cognitive impairment are ideal candidates.
Not a fit: Patients with epilepsy, significant visual or hearing impairments, pregnancy, migraine or dizziness triggered by VR, untreated dry eye, incompatible psychiatric disorders, or who do not master French are excluded and unlikely to benefit from these interventions.
Why it matters
Potential benefit: If successful, this approach could lower preoperative anxiety, improve sleep before surgery, and reduce postoperative pain and painkiller use for orthopedic patients.
How similar studies have performed: Previous small studies of music, binaural stimulation, hypnosis, and pilot virtual reality hypnosis have shown some benefits but evidence is still limited and larger comparative data are sparse.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient treated at the UAC D0 * Orthopedic patient (arthroplasty mainly) * Anesthesic procedure with general anesthesia * Patient \>18 years old without cognitive impairment in the investigator's judgment * Patient who has signed a free and informed consent * Patient affiliated to a social security scheme Exclusion Criteria: * Patient with deafness that does not allow him to perceive and understand sounds * Patient with a visual impairment who does not allow him to watch and understand a video * Patient who does not master the French language (spoken, written and read) * Patient with a history of epilepsy * Patient with a history of migraine/headache when using a virtual reality headset * Patients with a history of dizziness triggered by images (film, video game...) * Patient with untreated dry eye disease * Patient with psychiatric diseases and disorders not compatible with the study in the investigator's judgment * Patient who is pregnant, parturient, or breastfeeding. * Patient under guardianship or curatorship, under judicial protection or deprived of public law
Where this trial is running
Amiens, Picardie
- Amiens University Hospital — Amiens, Picardie, France (Recruiting)
Study contacts
- Study coordinator: François JOACHIM, MD
- Email: Joachim.francois@chu-amiens.fr
- Phone: 33+322088671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.