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Идёт набор NCT07450456

Effect of Virtual Reality on the Need of Premedication Before Surgery

Без фазы С лечением Anxiety Premedication Surgery Virtual Reality

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Virtual Reality.
Кому может быть актуально
Состояния в реестре: Anxiety, Premedication, Surgery, Virtual Reality. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Virtual Reality Immersion on the Need of Pharmacological Premedication Before Cardiac Surgery

Обзор

This study will assess, on patients requesting a pharmacological premedication in the preoperative period, if virtual reality reality could reduce the request of pharmacological premedication while maintaining a good level of comfort for the patient. The aim of this study is to understand if virtual reality could reduce the need for pharmacological premedication and their associated secondary effects.

Вмешательства

  • Устройство Virtual Reality
    The study intervention will take place on the day of surgery, in the ward, once patient's pre-operative preparation has been completed. The virtual reality device will be started according to the choices made by the patient (scenario and music) for a 20 min session. During that time, the patient will be left at rest and the interactions with the patient will be limited as much as possible.

Первичные конечные точки

  • Proportion of patients requiring pharmacological premedication after Virtual Reality (VR) intervention [Срок оценки: Up to the initiation of pre-oxygenation (same day)]
Вторичные конечные точки (12)
  • Richmond Agitation Sedation Score (RAAS) [Срок оценки: Prior to initiation of pre-oxygenation (intraoperative period, same day)]
  • Evaluation of Pa02 and PaC02 in theater [Срок оценки: Immediately after arterial line insertion and prior to initiation of pre-oxygenation (same day)]
  • External evaluation of patient's comfort [Срок оценки: At end of induction, after airway securement (same day)]
  • Post-operative qualitative survey [Срок оценки: From 4 hours after patient's extubation up to 72 hours after patient's extubation]
  • Compliance with the VR intervention [Срок оценки: From the beginning of the intervention up to the end of the intervention (planned duration of the intervention: 20 minutes)]
  • Post-operative evaluation of patient's satisfaction regarding pre-operative period [Срок оценки: From 4 hours after patient's extubation up to 72 hours after patient's extubation]
  • Incidence of cyberslckness [Срок оценки: From the beginning of the VR intervention up to 15 minutes after the end of the VR intervention]
  • Incidence of secondary effects linked to the use of anxiolytic premedication [Срок оценки: From administration of anxiolytic medication until initiation of pre-oxygenation (same day)]
  • Time to Administration of Anxiolytic Premedication [Срок оценки: Time interval (in minutes) between completion of the VR intervention and administration of anxiolytic premedication, including rescue premedication if applicable.]
  • Change in patient's anxiety over time using Visual Analogue Scale for anxiety scale (VASA) [Срок оценки: From immediately before VR session to operating room entry (same day)]
  • Change in patient's anxiety over time using Amsterdam Preoperative Anxiety and Information Scale (APAIS) [Срок оценки: From immediately before VR session to operating room entry (same day)]
  • Change in blood pressure over time [Срок оценки: From immediately before VR session to operating room entry (same day)]

Критерии участия

Критерии включения

  • All patients undergoing elective surgery
  • Minimal age of 18-year-old
  • Able to give informed consent for the study
  • Requesting pharmacological premedication in the pre-operative period.

Критерии исключения

  • Lacking capacity or ability to complete the consent form or to respond to the required obligations linked to the study protocol
  • Contraindications to pharmacological premedication
  • Known cognitive dysfunction, previous history of neurological/psychiatric diseases like epilepsy
  • Non Italian speaking patients
  • Injuries to the head/face that would prohibit wearing headsets
  • Infectious skin conditions of the head/face
  • Contact isolation due to bacteria and viruses
  • Symptoms of vertigo or motion sickness
  • Reduced visual or auditory acuity
  • Pregnancy
  • Claustrophobia

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Швейцария · 1 центр
  • Istituto Cardiocentro — Lugano

Идентификаторы

NCT: NCT07450456 · ID 2025-01864

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗