Comparing VR hypnosis, PSiO relaxation glasses, and no relaxation tool to reduce anxiety before orthopedic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Amiens University Hospital
  Amiens, Picardie, France Recruiting

Study contacts

• Study coordinator: François JOACHIM, MD
• Email: Joachim.francois@chu-amiens.fr
• Phone: 33+322088671

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.