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临床试验/NCT03426163
NCT03426163Unknown不适用

Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee: a Randomized Controlled Trial

Hanyang University Seoul Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
48
试验地点
1
主要终点
The Amsterdam perioperative anxiety and information scale (APAIS) score

研究概览

简要总结

Knee MRI is difficult for patients to understand as the image offers a single plane image. Accordingly,investigators sought to transfer the MRI image to 3-dimensional virtual reality system by Mesh rendering technique.

详细描述

The primary outcome of the study is APAIS score assessed at 24 hours postoperation. Experimental VR group will be applied with virtual reality transformed knee MRI whereas no interverntion group will be applied with traditional knee MRI. MRI will be transformed to virtual reality images by Mesh rendering technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

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

  • Undergoing elective knee arthroscopy surgery

排除标准

  • Infection, not willing to undergo study, mentally ill, severe osteoarthritis (KL grade III or more)

研究组 & 干预措施

VR group

Experimental

Application of virtual reality 12 hours before arthroscopic surgery

干预措施: Virtual reality (Device)

Non-VR group

No Intervention

Application of knee MRI 12 hours before arthroscopic surgery

结局指标

主要结局

The Amsterdam perioperative anxiety and information scale (APAIS) score

时间窗: postoperatively at 24 hours

surgery related anxiety and information score Interpretation: * minimum subscale scores: 2 * minimum combined anxiety component: 4 * maximum subscale scores: 10 * maximum combined anxiety component: 20 * The higher the scores the greater the degree of anxiety or need for additional information.

次要结局

  • Visual analogue scale (VAS) for satisfaction(postoperatively at 24 hours)

研究者

发起方
Hanyang University Seoul Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

JIN KYU LEE

Assistant Professor

Hanyang University Seoul Hospital

研究点 (1)

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