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

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.

Study Overview

• Status: Recruiting
• Conditions: Virtual Reality; Relaxation; Anxiety Preoperative
• Intervention / Treatment: Device: HypnoVR; Device: PSIO; Device: no relaxation tool

• Study Type: Interventional
• Enrollment (Estimated): 632
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François Joachim, MD; Phone Number: 33+322088671; Email: Joachim.francois@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • Amiens University Hospital
      • Sub-Investigator: Sandrine SORIOT-THOMAS, MD
      • Contact: François Joachim, MD; Phone Number: 33+322088671; Email: Joachim.francois@chu-amiens.fr
      • Sub-Investigator: Sylvie LANIER, IDE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HypnoVR group; 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; 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.
Experimental: PSIO Group; 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; 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.
Sham Comparator: Group without relaxation tool; the patient will wait 20-minute, without benefit of sendorial tools.	Device: no relaxation tool; Group without relaxation tool: the patient will wait 20-minute, without benefit of sendorial tools.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: virtual reality; relaxation; anxiety preoperative
• Other Study ID Numbers: PI2025_843_0184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No