Virtual Reality for Anxiety in Interventional Radiology Procedures

Официальное название

Effects of Virtual Reality in the Management of Anxiety in Patients Undergoing Interventional Radiology Procedures: Randomized Study

Обзор

The goal of this clinical trial is to learn if virtual reality works to reduce anxiety in patients undergoing interventional radiology procedures. The main questions it aims to answer are: Does virtual reality lower anxiety in patients undegoing minimally invasive procedures? Can it help the platient's compliance and operators' satisfaction? Researchers will compare virtual reality to usual preoperative care to see if virtual reality is effective. Participants will: Use virtual reality for 20 minutes before the intervention starts. Complete questionnaires before and after the procedure.

Подробное описание

Patients enrolled and assigned to group 1 will wear the virtual reality visor in the induction room, before entering the Angio Suite in which the procedure will take place. The study requires that before and at the end of the procedure, a measurement of blood pressure and heart rate in order to measure the change in the patient's anxiety state. At the end of the procedure, they will be administered satisfaction tests to interventional radiologists and patients. The viewers in question are Meta Quest 2. Through the use of these viewers, the patient will will watch a VR video containing music and natural images that can promote relaxation in preparation for the procedure.

Вмешательства

• Устройство Virtual reality headset
  Patients will use virtual reality before the procedure in addition to usual preoperative care.

Первичные конечные точки

• Anxiety change in STAI-S scale [Срок оценки: At baseline (before VR), after 15 minutes, after 1 hour]

Вторичные конечные точки (5)

• Change of anxiety (VAS-A score) [Срок оценки: At baseline (before VR), after 15 minutes, after 1 hour]
• Change in heart rate [Срок оценки: At baseline (before VR), after 15 minutes, after 1 hour]
• Change in blood pressure [Срок оценки: At baseline (before VR), after 15 minutes, after 1 hour]
• Patient satisfaction on a scale from 0 to 10 [Срок оценки: After 1 hour]
• Operator satisfaction on a 0-10 scale [Срок оценки: After 1 hour]

Критерии участия

Критерии включения

• Indication to CT-guided biopsy in local anesthesia
• Informed consent signature

Критерии исключения

• Lack of patient consent to trial.
• Lack of eligibility to perform CT-guided needle biopsy, or eligibility to perform the procedure but with administration of general anesthesia or sedation.
• patients who do not speak Italian or English will be excluded;
• patients with visual and/or hearing impairment;
• patients on analgesics or anxiolytics;
• patients with the following conditions: dementia, psychiatric disorders; headache, dizziness, recent head injury, epilepsy, and other conditions in which the application of VR glasses has been judged to be potentially harmful; and when the topical anesthetic (lidocaine and prilocaine \[eutectic mixture of local anesthetic (EMLA)\]) or tetracaine (Ametop) was not properly applied before surgery.

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

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• IRCCS Istituto Ortopedico Rizzoli — Bologna

Идентификаторы

NCT: NCT06745765 · CE AVEC: 622/2024/Sper/IOR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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