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Recruiting NCT07557550

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

No phase Interventional Relaxation Virtual Reality Anxiety Preoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HypnoVR, PSIO, no relaxation tool.
Who it may be relevant to
Registry conditions: Relaxation, Virtual Reality, Anxiety Preoperative. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • Variation in the score on the APAIS anxiety scale [Time frame: 1 hour]
Secondary outcome measures (7)
  • Heart rate variation [Time frame: 1 hour]
  • Variation in respiratory rate [Time frame: over 1 minute]
  • Blood pressure variation [Time frame: 1 hour]
  • Variation in oxygen saturation [Time frame: 1 hour]
  • Quantity of product used [Time frame: 1 hour]
  • Time spent in the recovery room [Time frame: 1 hour]
  • Level of pain [Time frame: 1 hour]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Amiens University Hospital — Amiens

Identifiers

NCT: NCT07557550 · PI2025_843_0184

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗