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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство no relaxation tool
  Group without relaxation tool: the patient will wait 20-minute, without benefit of sendorial tools.

Первичные конечные точки

• Variation in the score on the APAIS anxiety scale [Срок оценки: 1 hour]

Вторичные конечные точки (7)

• Heart rate variation [Срок оценки: 1 hour]
• Variation in respiratory rate [Срок оценки: over 1 minute]
• Blood pressure variation [Срок оценки: 1 hour]
• Variation in oxygen saturation [Срок оценки: 1 hour]
• Quantity of product used [Срок оценки: 1 hour]
• Time spent in the recovery room [Срок оценки: 1 hour]
• Level of pain [Срок оценки: 1 hour]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Amiens University Hospital — Amiens

Идентификаторы

NCT: NCT07557550 · PI2025_843_0184

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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