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

NCT07557550 | Recruiting

• 1 other identifier: PI2025_843_0184
• Study Type: interventional
• Target: 632
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relaxation; Virtual Reality; Anxiety Preoperative

Keywords

relaxation; virtual reality; anxiety preoperative

Outcome Measures

Primary Outcomes (1)

• Variation in the score on the APAIS anxiety scale

  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)

  1 hour

Secondary Outcomes (7)

• Heart rate variation

  1 hour

• Variation in respiratory rate

  over 1 minute

• Blood pressure variation

  1 hour

• Variation in oxygen saturation

  1 hour

• Quantity of product used

  1 hour

Study Arms (3)

HypnoVR group

EXPERIMENTAL

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: HypnoVR

PSIO Group

EXPERIMENTAL

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: PSIO

Group without relaxation tool

SHAM COMPARATOR

the patient will wait 20-minute, without benefit of sendorial tools.

Device: no relaxation tool

Interventions

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.

PSIO Group

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.

HypnoVR group

no relaxation tool DEVICE

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

Group without relaxation tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Amiens University Hospital

Amiens, Picardie, 80054, France

RECRUITING

Central Study Contacts

François JOACHIM, MD

CONTACT

33+322088671; Joachim.francois@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 29, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)