跳至主要内容
临床试验/NCT05458999
NCT05458999Unknown不适用

Decreasing Patient Anxiety During Percutaneous Revascularization of Chronic Total Coronary Occlusions Using Virtual Reality Glasses.

Fundación para la Investigación del Hospital Clínico de Valencia2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
58
试验地点
2
主要终点
Anxiety

研究概览

简要总结

Percutaneous coronary angioplasty on chronic total occlusions is a complex procedure. The possibility of performing these procedures without anesthesia and sedation avoids the risks associated with anesthesia and sedation, but, on the contrary, subjects the patient to pain and anxiety during the procedure.

Virtual reality (VR) has been successfully used in several clinical settings to reduce intra-procedural anxiety.

The aim of this clinical trial is to determine whether the use of a VR system in PCI procedures on CTO decreases the level of anxiety and pain during the procedure.

详细描述

Percutaneous coronary intervention (PCI) on chronic total occlusions (CTO) represents one of the greatest challenges in interventional cardiology, due to the complexity of these procedures and the increased risk of complications. In recent decades, advances in techniques and devices have made it possible to obtain better results while reducing the associated complications.

The possibility of performing these procedures without anesthesia or sedation avoids the risks derived from these, but, on the contrary, subjects the patient to pain and anxiety during the procedure. Several factors influence patient anxiety: long duration of procedures, patient immobility (especially in biradial access), monotonous and hostile environment (operating rooms or catheterization rooms). Anxiety and pain are treated by pretreatment with oral benzodiazepines supplemented by opioids or intravenous benzodiazepines on demand during the procedure, assuming the possible complications derived from this treatment.

Virtual reality (VR) has been used successfully in several clinical settings to reduce intra-procedural anxiety. A reduction in anxiety and pain has been demonstrated even in elderly patients undergoing percutaneous aortic valve replacement. Its use does not require technical expertise or experience in the use of digital devices and does not increase the sensation of dizziness or nausea.

The aim of this study is to determine whether the use of a VR system in PCI procedures over CTO decreases the level of anxiety and pain during the procedure.

Method

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic total oclussion scheduled percutaneous coronary intervention.

排除标准

  • Less than 18 years old.
  • Visual deficits
  • Language barrier
  • Any other situation that would prevent the use of VR goggles.
  • Inability or refusal to provide informed consent.

结局指标

主要结局

Anxiety

时间窗: Intraprocedure

Maximum level of anxiety perceived by the patient measured by a visual analog scale (VASa) (1-10) and determined at the end of the procedure.

次要结局

  • Pain level(Intraprocedure)
  • Need of anxiolytic treatment(Intraprocedure)

研究者

发起方
Fundación para la Investigación del Hospital Clínico de Valencia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Agustín Fernández

Interventional Cardiologist

Fundación para la Investigación del Hospital Clínico de Valencia

研究点 (2)

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