Video Diversion During Fundoscopic Exam in Children

Not Applicable

Completed

• Conditions: Other Disorders of Optic Disc, Bilateral
• Interventions: Other: Video (played on a computer monitor)

• Registration Number: NCT01673815
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-03
• Status Verified: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2012-08-20
• Study First Submitted QC: 2012-08-23
• Last Update Submitted: 2012-08-23
• Study First Posted: 2012-08-28
• Last Update Posted: 2012-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1st: R eye video. 2nd: L eye no video	Video (played on a computer monitor)	The right eye will be examined first with video, followed by the left eye without video.
1st: R eye no video. 2nd: L eye video	Video (played on a computer monitor)	The right eye will be examined without video, followed by the left eye with video.
1st: L eye video. 2nd: R eye no video	Video (played on a computer monitor)	The left eye will be examined first with video, followed by the right eye without video.
1st: L eye no video. 2nd: R eye video	Video (played on a computer monitor)	The left eye will be examined first without video, followed by the right eye with video.

Primary Outcome Measures

Name	Time	Method
Success rate of visualizing the optic disk within 60 seconds	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.

Secondary Outcome Measures

Name	Time	Method
Reduction in the amount of time needed to visualize the optic disk.	At the time of fundoscopy exam	To determine whether showing a video clip with sound of the patient's choice can reduce the amount of time needed to perform a successful fundoscopic 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	Improvement in the physician's and caregiver's (parent/legal guardian) perception of the ease of the fundoscopic exam as determined by a 10 point likert scale (1 being easiest and 10 being hardest).

Trial Locations

Locations (1)

BC Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada