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Recruiting Not applicable

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

NCT07557550 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-04-01
Last updated
2026-04-29

Condition(s) studied

RelaxationVirtual RealityAnxiety Preoperative

Investigational drug(s) / intervention(s)

HypnoVRPSIOno relaxation tool

HypnoVR: The patient will benefit from a 20-minute virtual reality hypnosis session in the universe of his choice. The experience consists of hypnotic speech, adapted to the study population, inducing a state of relaxation (guided breathing sequences, cardiac coherence exercises, positive suggestions), an evolving 3D virtual journey and a musical atmosphere.

PSIO: the patient will be given a 20-minute relaxation session with the PSiO® glasses. The experience consists of a visual stage with shimmering colors and music.

no relaxation tool: Group without relaxation tool: the patient will wait 20-minute, without benefit of sendorial tools.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Variation in the score on the APAIS anxiety scale — 1 hour
    Variation in the score on the APAIS scale, 6-item scale rated from 1 to 5 The anxiety score sums items 1, 2, 4 and 5 (\>11 = anxious subjects) The information desire score sums items 3 and 6 (2 to 4 = refusal of information, 5 to 7 = average desire for information, \>7 = eager desire for information)

Trial sites (1)

FacilityCityRegionStatus
Amiens University Hospital Amiens Picardie Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07557550 on ClinicalTrials.gov ↗ ← All trials in France