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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07557550
Acronym
RELAXPREOP
Enrollment
632
Registered
2026-04-29
Start date
2026-04-01
Completion date
2027-04-01
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Preoperative, Relaxation, Virtual Reality

Keywords

relaxation, virtual reality, anxiety preoperative

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.

Interventions

DEVICEHypnoVR

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.

DEVICEPSIO

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.

DEVICEno relaxation tool

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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Variation in the score on the APAIS anxiety scale1 hourVariation 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

MeasureTime frameDescription
Heart rate variation1 hourHeart rate variation measured by a pulse oximeter
Variation in respiratory rateover 1 minuteVariation in respiratory rate measured over 1 minute with a stopwatch
Blood pressure variation1 hourBlood pressure variation measured with a blood pressure monitor
Variation in oxygen saturation1 hourVariation in oxygen saturation measured with a pulse oximeter
Quantity of product used1 hourQuantity of product used as recorded in the electronic patient record
Time spent in the recovery room1 hourTime spent in the recovery room recorded in the computerized patient file
Level of pain1 hourLevel of pain measured by a VAS

Countries

France

Contacts

CONTACTFrançois JOACHIM, MD
Joachim.francois@chu-amiens.fr33+322088671

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026