Effects of Virtual Reality in the Management of Anxiety in Patients Undergoing Interventional Radiology Procedures: Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Anxiety change in STAI-S scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication to CT-guided biopsy in local anesthesia
- •Informed consent signature
排除标准
- •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.
研究组 & 干预措施
VR
Patients will use virtual reality before the procedure in addition to usual preoperative care.
干预措施: Virtual reality headset (Device)
NO VR
Patients will not use virtual reality; hence, they will experience usual preoperative care.
结局指标
主要结局
Anxiety change in STAI-S scale
时间窗: At baseline (before VR), after 15 minutes, after 1 hour
This subscale measures state anxiety, which is the anxiety temporary that an individual experiences in a specific situation. È designed to assess an individual's reaction to a particular event or situation particular moment at a specific time. Questions are phrased to reflect feelings such as tension, worry, agitation, and nervousness. Each item is formulated as a statement to which individuals must respond by indicating their level of agreement or discomfort on a 4-point scale. Scoring system: * 20-37: Low Anxiety * 38-44: Moderate anxiety * 45-80: High anxiety A difference of at least 3 points on the scale between the two groups is considered significant. Scores will be assessed before and after the use of virtual reality (for patients in VR group) and after the procedure.
次要结局
- Change of anxiety (VAS-A score)(At baseline (before VR), after 15 minutes, after 1 hour)
- Change in heart rate(At baseline (before VR), after 15 minutes, after 1 hour)
- Change in blood pressure(At baseline (before VR), after 15 minutes, after 1 hour)
- Patient satisfaction on a scale from 0 to 10(After 1 hour)
- Operator satisfaction on a 0-10 scale(After 1 hour)
研究者
Giancarlo Facchini
Medical Doctor
Istituto Ortopedico Rizzoli