Evaluation of the Effects of Virtual Reality on Preoperative Anxiety in Refractive Surgery

Обзор

The objective of this study is to determine to what extent the use of a software application prior to refractive surgery involving multisensory immersion (visual and auditory) in a hypnotic and relaxing sound and visual environment can reduce anxiety levels. The assessment of preoperative anxiety levels will be based on the administration of a psychometric scale (APAIS scale) and the measurement of salivary cortisol, which is a sensitive marker of the patient's stress level.

Подробное описание

This is a prospective, randomized, open-label, single-center study conducted on two parallel groups of patients undergoing refractive surgery (virtual reality preoperative conditioning or routine preoperative procedure). Therapeutic benefit is based on the assessment of preoperative anxiety using the APAIS scale.

Вмешательства

• Устройство Virtual reality
  Virtual reality hypnosis software applications are Class I medical devices according to Rule 12 of Directive 93/42/EC. They allow, through a virtual reality headset and headphones, to immerse the patient in a hypnotic sound and visual environment. Several visual scenarios can be proposed, allowing the patient to virtually travel to a beach, the seabed, on an alpine walk, etc.). The HypnoVR Biofeedback virtual reality device is provided by the HypnoVR company.
• Процедура Usual Care Group
  Routine preoperative procedure (local anesthesia)

Первичные конечные точки

• Preoperative anxiety level [Срок оценки: Preoperative procedure]

Вторичные конечные точки (12)

• Intraoperative pain intensity [Срок оценки: Immediately after surgery]
• Postoperative pain intensity [Срок оценки: 15 minutes after the End of surgery]
• Intraoperative comfort [Срок оценки: 15 minutes after the End surgery]
• Postoperative Overall Patient Satisfaction [Срок оценки: 15 minutes after the End of surgery]
• Change in salivary cortisol [Срок оценки: Before any study procedure]
• Change in salivary cortisol [Срок оценки: Just before surgery]
• Change in salivary cortisol [Срок оценки: 15 minutes after the end of surgery]
• Heart rate [Срок оценки: Before any study procedure]
• Blood pressure [Срок оценки: Before any study procedure]
• Heart rate [Срок оценки: Before surgery]
• Blood pressure [Срок оценки: Before surgery]
• Heart rate [Срок оценки: 15 minutes after the end of surgery]

Критерии участия

Критерии включения

• Patient aged 18 years or older,
• Patient who has read and signed the consent form for participation in the study after a reflection period (between 10 and 45 minutes)
• Patient who is a candidate for refractive surgery

Критерии исключения

• Contraindication to virtual reality (uncontrolled epilepsy, hearing impairment)
• Pregnant or breastfeeding patient
• Cushing's disease, Addison's disease, hypo- or hyperthyroidism
• Patient treated with topical or systemic corticosteroids
• Patient treated with neuroleptics, anxiolytics, or antidepressants
• Patient under legal protection, guardianship, or curatorship
• Patient participating in another blinded research study
• Patient not affiliated with the French social security system
• Patient unable to understand the information provided and/or give written informed consent: dementia, psychosis, impaired consciousness, non-French-speaking patient

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

Лечение

Центры проведения

Франция · 1 центр

• Clinique Monticelli — Marseille

Идентификаторы

NCT: NCT07050498 · 2023-A01771-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗