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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

632 Participants
are divided into 3 treatment groups
Group A: HypnoVR groupExperimental treatment 1 intervention
Group B: PSIO GroupExperimental treatment 1 intervention
Group C: Group without relaxation toolSham comparator 1 intervention

Trial outcomes

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)

Time frame
1 hour

Secondary outcomes

1

Heart rate variation

Heart rate variation measured by a pulse oximeter

Time frame
1 hour
2

Variation in respiratory rate

Variation in respiratory rate measured over 1 minute with a stopwatch

Time frame
over 1 minute
3

Blood pressure variation

Blood pressure variation measured with a blood pressure monitor

Time frame
1 hour
4

Variation in oxygen saturation

Variation in oxygen saturation measured with a pulse oximeter

Time frame
1 hour

Other outcomes

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