Virtual Reality to Reduce Periprocedural Anxiety During Invasive Coronary Angiography: Rationale and Design of the VR InCard Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- NRS anxiety
研究概览
简要总结
Introduction Patients undergoing invasive coronary angiography experience anxiety due to various factors. This can lead to physiological and psychological complications, compromising patient comfort and overall procedural outcomes. Benzodiazepines are commonly used to reduce periprocedural anxiety, although the effect is modest. VR is an promising nonpharmacological intervention that can be used to reduce anxiety in patients undergoing an invasive coronary angiography.
Methods and analysis A single-center open-label randomized controlled trial was performed to assess the effectiveness of add-on VR therapy on anxiety in 100 patients undergoing invasive coronary angiography and experiencing anxiety in periprocedural setting. The primary outcome is the NRS anxiety score measured just before obtaining arterial access. Secondary outcomes are physiological measures of anxiety and the State-Trait Anxiety Inventory, Perceived Stress Scale, and IGroup presence questionnaire. The NRS anxiety level and physiological measurements will be taken at five scheduled times between pre procedural, peri and post procedural. The State-Trait Anxiety Inventory and Perceived Stress Scale will be performed prior to coronary angiography and the State-Trait Anxiety Inventory (state form) and the IGroup Presence questionnaire will be performed post-intervention.
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
- •Patient ≥16 years undergoing elective cardiac catheterisation
- •Patient is willing and able to comply with the study protocol
- •NRS anxiety score ≥ 4
排除标准
- •History of dementia
- •Severe hearing/visual impairment not corrected
- •Depression or anxiety disorder
结局指标
主要结局
NRS anxiety
时间窗: Assessed at established moment right before start op procedure.
Numeric rating score for anxiety with 0 representing no anxiety and 10 the worst anxiety imaginable.
次要结局
- anxiolytics use(At t2 20 minutes after t1 right before patients transfers to procedure room and t5 10min after end of procedure)
- NRS anxiety(At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure)
- blood pressure(At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure)
- respiration rate(At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure)
- Igroup presence questionnaire(t5 10min after end of procedure)
- heart rate(At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure)
- STAI-trait(At t0 baseline)
- Patient satisfaction(At t5 10min after end of procedure)
- complexity of procedure(At t5 10min after end of procedure)
- STAI-state short form(At t0 baseline and t5 10min after end of procedure)
- Perceived stress questionnaire(At t0 baseline)
- Pain during arterial punction(At t4 during procedure (directly after arterial access))
- Cardiologist satisfaction with procedure(At t5 10min after end of procedure)
- Radial artery spasm yes/no(At t5 10min after end of procedure)
- Total finished VR sessions(t5 10min after end of procedure)
- Total duration of VR use(t5 10min after end of procedure)
- heart rate variability(At set moments: t0 baseline, t1 20-25min preprocedural, t2 20min after t1 right before transfer to procedure room, t3 5 minutes before start procedure, t4 during procedure (directly after arterial access), t5 10min after end of procedure)