NCT07557550 Comparison of Two Relaxation Strategies Between Glasses, Virtual Reality Headset, and Without Relaxation Tool, in the Anxiety Preoperative of Orthopedic Adult Patients
| NCT ID | NCT07557550 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Relaxation |
| Study Type | INTERVENTIONAL |
| Enrollment | 632 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 632 participants in total. It began in 2026-04-01 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In adults, the prevalence of preoperative anxiety related to surgery or anesthesia ranges from 60 to 80%, and context plays an important role. Patients with significant preoperative anxiety experience reduced sleep quality. In addition, high preoperative anxiety is linked to more severe postoperative pain and an increased need for painkillers. In addition, it is a source of dysfunction in care. Currently, there are no recommendations regarding the prevention of preoperative anxiety. New approaches have emerged that show some benefit: music, binaural auditory stimulation and hypnosis. In the UAC J0 unit of the Amiens-Picardie University Hospital, the caregivers offer the PSiO glasses, a tool combining three techniques: light therapy, relaxation and chromotherapy. This system has obtained CE and FCC markings and seems to be more or less effective on patients admitted to the CH . A pilot study evaluating the effects of virtual reality hypnosis on patients' preoperative anxiety has shown that this technology represents a non-invasive way to reduce preoperative stress levels without side effects and without the need for additional medical or paramedical staff. This study aims to improve the patient's well-being before their operation. Depending on the randomization, he will benefit from a relaxation session with the Psio glasses or a virtual reality hypnosis session with the Hypno VR headset. Follow-up of patients will be carried out on the basis of variation in an anxiety scale, physiological criteria, the amount of anesthetic products used, the time spent in the recovery room, and the evaluation of pain.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07557550 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relaxation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07557550 currently recruiting?
Yes, NCT07557550 is actively recruiting participants. Contact the research team at Joachim.francois@chu-amiens.fr for enrollment information.
Where is the NCT07557550 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT07557550 clinical trial?
NCT07557550 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 632 participants.