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临床试验/NCT01673815
NCT01673815已完成不适用

Video Diversion During Fundoscopic Exam in Children: A Randomized Controlled Trial

University of British Columbia2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Success rate of visualizing the optic disk within 60 seconds

研究概览

简要总结

Fundoscopy is an important aspect of the neurological examination, but can be challenging in uncooperative children. This study explored whether viewing a video (selected by patient or caregiver) during eye examination improves the success, duration and ease of pediatric fundoscopy.

Hypothesis: Showing a short video clip during a fundoscopic exam will increase the probability of successfully visualizing the optic disk and reduce the amount of time needed to perform a fundoscopic exam in children between 1-8 years old.

详细描述

The purpose of this study is to examine whether showing a video clip with sound of the patient's choice can improve the ease of fundoscopic exam as defined by improved success of visualizing the optic disk and the reduction in time needed to perform the exam. The investigators will also examine the physician's and caregiver's perception on whether the video was effective in improving the ease of the exam. The purpose of the video is to capture the visual attention of the patient thereby allowing the physician to swiftly perform the fundoscopic exam. The literature has suggested that young patients are most uncooperative, therefore the investigators will focus our study on younger patients 1-8 years old.

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
1 Year 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 1-8 years old
  • Capable of visualizing the video monitor
  • Patient has 2 examinable eyes

排除标准

  • Blind patient
  • Patients < 1 or > 8 years old

研究组 & 干预措施

1st: R eye video. 2nd: L eye no video

Experimental

The right eye will be examined first with video, followed by the left eye without video.

干预措施: Video (played on a computer monitor) (Other)

1st: R eye no video. 2nd: L eye video

Experimental

The right eye will be examined without video, followed by the left eye with video.

干预措施: Video (played on a computer monitor) (Other)

1st: L eye video. 2nd: R eye no video

Experimental

The left eye will be examined first with video, followed by the right eye without video.

干预措施: Video (played on a computer monitor) (Other)

1st: L eye no video. 2nd: R eye video

Experimental

The left eye will be examined first without video, followed by the right eye with video.

干预措施: Video (played on a computer monitor) (Other)

结局指标

主要结局

Success rate of visualizing the optic disk within 60 seconds

时间窗: At the time of fundoscopy exam

To determine whether showing a video clip with sound of the patient's choice can improve the success of fundoscopic exam in children as defined by the ability to visualize the optic disk within 60 seconds.

次要结局

  • Reduction in the amount of time needed to visualize the optic disk.(At the time of fundoscopy exam)
  • Improvement in the physician's and caregiver's (parent/legal guardian) perception of the ease of the fundoscopic exam.(At the time of fundoscopy exam)

研究者

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

Ash Singhal

principal investigator

University of British Columbia

研究点 (2)

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