Acute Clinical Outcomes Following the Implementation of Virtual Reality (VR) in the Electrophysiology Laboratory
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain and discomfort
研究概览
简要总结
Pain during pacemaker or defibrillator implantation can increase patient discomfort, anxiety, and the need for deeper sedation. Using virtual reality (VR) as a non-pharmacological distraction tool may help reduce perceived pain, stabilize vital signs, and improve the overall patient experience. This prospective, single-center study evaluates whether adding VR to standard sedation lowers pain levels compared to sedation alone. Patients undergoing device implantation will be randomized to either group, with pain and vital signs monitored throughout the procedure. The study also explores patient satisfaction, adverse effects, and the potential of VR to support same-day discharge after minimally invasive procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Age ≥ 18 years.
- •Patients who are candidates for pacemaker (PM) or implantable cardioverter-defibrillator (ICD) implantation, including new devices such as leadless PM and subcutaneous ICD (S-ICD).
- •Ability to provide written informed consent.
- •Ability to understand the use of the VR headset and express a pain score using the NRS scale.
排除标准
- •Severe cognitive, psychiatric or neurological disorders that impair understanding or collaboration in the study.
- •Visual and/or auditory and inner ear disorders or severe vertigo that could be aggravated by VR.
- •Allergies or known adverse reactions to standard sedative therapies provided for in the protocol (e.g. midazolam) if essential for the procedure.
- •Inability to correctly position the VR headset (e.g. severe facial deformities, recent trauma to the craniofacial area).
结局指标
主要结局
Pain and discomfort
时间窗: during electrophysiology procedures
To evaluate the difference in pain perception between a group using virtual reality (VR) and a control group subjected only to standard sedation, measured using the Numeric Rating Scale (NRS). The NRS is a self-reported scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater pain and discomfort. The NRS will be recorded at the end of the procedure, referring to the pain experienced during the entire electrophysiology procedure.
Oxygen Saturation
时间窗: during electrophysiology procedures
To compare the change in oxygen saturation (SpO₂, %) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
Systolic Blood Pressure
时间窗: during electrophysiology procedures
To compare the change in systolic blood pressure (mmHg) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
Heart Rate
时间窗: during electrophysiology procedures
To compare the change in heart rate (beats per minute) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
Respiratory Rate
时间窗: during electrophysiology procedures
To compare the change in respiratory rate (breaths per minute) during the procedure between the virtual reality (VR) group and the control group receiving standard sedation. Measurements will be taken at baseline, 15, 30, 45, and 60 minutes, and at the end of the procedure. The difference between groups will be assessed at each time point.
次要结局
- Patient satisfaction(during electrophysiology procedures)
- Hospital stay length(through study completion, an average of 7 days)
研究者
Antonio Curcio
Professor
University of Calabria