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

NCT07557550 — Not applicable, Recruiting, 632 participants, Centre Hospitalier Universitaire, Amiens

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Registry	NCT07557550, acronym RELAXPREOP
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, other
Enrollment	632 (Estimated)
Sponsor	Centre Hospitalier Universitaire, Amiens (Other)
Conditions	Relaxation, Virtual Reality, Anxiety Preoperative
Interventions	HypnoVR, PSIO, no relaxation tool (Device)
Dates	start 2026-04-01, primary completion 2027-04-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-04-29, last updated 2026-04-29
Locations	1 site in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
HypnoVR group	Experimental	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.
PSIO Group	Experimental	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.
Group without relaxation tool	Sham comparator	Device: no relaxation tool	the patient will wait 20-minute, without benefit of sendorial tools.

HypnoVR (Device): 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 (Device): 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 (Device): Group without relaxation tool: the patient will wait 20-minute, without benefit of sendorial tools.

+Outcome measures

Primary outcomes

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)

Secondary outcomes

Heart rate variation [1 hour]: Heart rate variation measured by a pulse oximeter
Variation in respiratory rate [over 1 minute]: Variation in respiratory rate measured over 1 minute with a stopwatch
Blood pressure variation [1 hour]: Blood pressure variation measured with a blood pressure monitor
Variation in oxygen saturation [1 hour]: Variation in oxygen saturation measured with a pulse oximeter
Quantity of product used [1 hour]: Quantity of product used as recorded in the electronic patient record
Time spent in the recovery room [1 hour]: Time spent in the recovery room recorded in the computerized patient file
Level of pain [1 hour]: Level of pain measured by a VAS

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Amiens University Hospital	Amiens, Picardie	France	Recruiting

My Notes

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