跳至主要内容
临床试验/NCT04490603
NCT04490603招募中不适用

The Effect of Virtual Reality Experience on Infusion-related Pain With Lumbar Epidural Catheterization: A Prospective, Randomized Comparative Study.

Seoul National University2 个研究点 分布在 2 个国家目标入组 72 人开始时间: 2020年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
2
主要终点
Procedure-related pain

研究概览

简要总结

This clinical trial aims to analyze the effect of virtual reality experience on infusion-related pain with lumbar epidural catheterization.

详细描述

Patients with chronic pain are to suffer from acute pain during their chronic pain-relieving interventions. However, there is no active countermeasure against pain during these procedures. This prospective randomized clinical study seeks to find an appropriate solution to the procedure related acute pain of these patients by actively utilizing virtual reality experiences.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • If all of the following conditions are met
  • A person with chronic low back pain that lasts more than 3 months due to spinal stenosis or lumbar disc disease.
  • Adults over 20
  • Those who decided to participate out of his/her own free will and signed in written consent

排除标准

  • If the patient meets one or more of the following criteria, He or She cannot participate this clinical trial.
  • In case of contraindication to general lumbar catheterization (e.g. coatulopathy, infection, etc)
  • Hearing and vision impairments
  • Affective disorder
  • History of epilepsy or seizure
  • If communication is not possible due to impaired cognitive ability
  • Those who have been deemed inappropriate by the researchers

结局指标

主要结局

Procedure-related pain

时间窗: Right after the produre for 50 minutes ended.

Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)

次要结局

  • Intervention-related wellness index-1 (IWI-1)(Right after the produre for 50 minutes ended.)
  • Patient satisfaction with virtual reality experience(Right after the produre for 50 minutes ended.)
  • Intervention-related wellness index-2 (IWI-2)(Right after the produre for 50 minutes ended.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeeyoun Moon

Associate professor

Seoul National University

研究点 (2)

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