Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07557550

Comparison of Two Relaxation Strategies Between Glasses, Virtual Reality Headset, and Without Relaxation Tool, in the Anxiety Preoperative of Orthopedic Adult Patients

Led by Centre Hospitalier Universitaire, Amiens · Updated on 2026-04-29

632

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient treated at the UAC D0
  • Orthopedic patient (mainly arthroplasty)
  • Scheduled for anesthesia with general anesthesia
  • At least 18 years old with no cognitive impairment as judged by the investigator
  • Signed informed consent
  • Affiliated with a social security scheme
Not Eligible

You will not qualify if you...

  • Deafness preventing perception and understanding of sounds
  • Visual impairment preventing watching and understanding videos
  • Does not master spoken, written, and read French
  • History of epilepsy
  • History of migraine or headache when using virtual reality headset
  • History of dizziness triggered by images (films, video games, etc.)
  • Untreated dry eye disease
  • Psychiatric diseases or disorders incompatible with the study as judged by the investigator
  • Pregnant, parturient, 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

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Trial Site Locations

Total: 1 location

1

Amiens University Hospital

Amiens, Picardie, France, 80054

Actively Recruiting

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Research Team

F

François JOACHIM, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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Comparison of Two Relaxation Strategies Between Glasses, Virtual Reality Headset, and Without Relaxation Tool, in the Anxiety Preoperative of Orthopedic Adult Patients | DecenTrialz