Virtual Reality in Electrophysiological Procedures and Device Implantation: the VR inEP Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 115
- 主要终点
- Anxiety
研究概览
简要总结
Each year about 37,000 patients undergo a catheter ablation to treat cardiac arrhythmias or have a cardiac device such as a pacemaker or implantable cardioverter defibrillator implanted in the Netherlands. Although the procedures positively impact health related outcomes on the long term, they are often accompanied by periprocedural pain and anxiety on a shorter term. These negative effects can be prevented or treated by pharmacological interventions (e.g. analgesics or benzodiazepines), but side effects of these drugs may compromise patient safety and extend hospital admissions. Distraction using Virtual Reality (VR) may be an attractive non-pharmacological alternative.
It is the aim of the Virtual Reality in Electrophysiological Procedures and device implantation (VR inEP) trial to study the feasibility and efficacy of VR to decrease experienced pain and anxiety in patients undergoing invasive procedures for arrhythmias and conduction disorders. The study also serves as a stepping stone towards structural implementation of VR into clinical care, by familiarizing care personnel of the cardiac catheterization rooms with the use of VR, its indications and logistics, and identifying potential barriers for structural implementation of VR.
VR inEP is a single-center, open label, randomized controlled trial performed in the catheterization rooms in the Radboudumc. Adult patients undergoing an electrophysiological procedure (e.g., catheter ablation or electrophysiological study) or cardiac device implantation (e.g., pacemaker or implantable cardioverter defibrillator) performed under local anesthesia are eligible for inclusion. Patients consenting to participate are randomized in a 1:1 ratio to the VR intervention or control group, stratified for the indication for the procedure (50% electrophysiological procedures, 50% cardiac device implantations). Patients and their treatment teams are unblinded for the treatment allocation. The primary outcomes are pain perception and anxiety during the procedure as a whole, quantified using the visual analog scale (VAS) for pain and the numeric ranking scale (NRS) for anxiety, 30 minutes after the procedure ends.
详细描述
Rationale: Each year approximately 37,000 patients undergo a catheter ablation or cardiac device implantation in The Netherlands. Although the procedures positively impact health related outcomes, they are often accompanied by periprocedural pain and anxiety. These negative effects can be prevented or treated by pharmacological interventions (e.g. analgesics or benzodiazepines), but side effects of these drugs may compromise patient safety and extend hospital admissions. Distraction using Virtual Reality (VR) may be an attractive non-pharmacological alternative.
Objective: it is the aim of the Virtual Reality in Electrophysiological Procedures and device implantation (VR inEP) trial to study the feasibility and efficacy of VR to decrease experienced pain and anxiety in patients undergoing invasive procedures for arrhythmias and conduction disorders. The study also serves as a stepping stone towards structural implementation of VR into clinical care, by familiarizing care personnel of the cardiac catheterization rooms with the use of VR, its indications and logistics, and identifying potential barriers for structural implementation of VR.
Study design: VR inEP is a single-center, open label, randomized controlled trial performed in the catheterization rooms in the Radboudumc.
Study population: Adult patients undergoing an electrophysiological procedure (e.g., catheter ablation or electrophysiological study) or cardiac device implantation (e.g., pacemaker or implantable cardioverter defibrillator) performed under local anesthesia are eligible for inclusion.
Intervention: Patients consenting to participate are randomized in a 1:1 ratio to the VR intervention or control group, stratified for the indication for the procedure (50% electrophysiological procedures, 50% cardiac device implantations). Patients and their treatment teams are unblinded for the treatment allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥16 years of age
- •Planned to undergo an invasive electrophysiological procedure (e.g., catheter ablation or electrophysiological study) or cardiac device implantation (e.g., pacemaker or implantable cardioverter defibrillator).
- •The procedure must be performed under local anesthesia.
排除标准
- •Patients undergoing procedures using (conscious) sedation
- •Patients who do not speak or understand Dutch
- •History of dementia
- •Severe visual impairment.
研究组 & 干预措施
VR therapy
干预措施: VR therapy (Other)
VR therapy
干预措施: 360 degree education videos (Other)
Control group
The control group is treated according to the local protocol, which may encompass preprocedural administration of benzodiazepines or analgesics depending on the procedure type and indication, nurses' assessment, patient preference, comorbidities, and medication use. These medications will be administered after randomization and baseline assessment of anxiety and pain. If required during the procedure, additional analgesics may be administered (usually fentanyl).
结局指标
主要结局
Anxiety
时间窗: 0.5-6 hours
The second primary outcome is anxiety during the procedure as a whole, quantified using the numeric ranking scale (NRS, 0-10 points) 30 minutes after the procedure ends.
Pain perception
时间窗: 0.5-6 hours
Pain perception during the procedure as a whole, quantified using the visual analogue scale (VAS, 0-10 points) 30 minutes after the procedure ends.
次要结局
- Use of analgesics(0.5-6 hours)
- Self-reported acceptable pain(0.5-6 hours)
- Worst pain(0.5-6 hours)
- Time experience(0.5-6 hours)
- Heart rate variability(0.5-6 hours)
- Procedural duration(0.5-6 hours)
- Duration of hospital admission after finalization of the procedure(0-7 days)
- Time of VR use as a percentage of total procedural duration(0.5-6 hours)
- Patient satisfaction with the VR therapy and the optional educational video(0.5-10 hours)
- Procedural satisfaction of health care professionals with VR(0.5-10 hours)
- Number of patients with complications(0.5-6 hours)