Video Diversion During Fundoscopic Exam in Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Other Disorders of Optic Disc, Bilateral

Intervention / Treatment
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* Other: Video (played on a computer monitor)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1-8 years old Capable of visualizing the video monitor Patient has 2 examinable eyes Exclusion Criteria: Blind patient Patients < 1 or > 8 years old

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1st: R eye video. 2nd: L eye no video<br>The right eye will be examined first with video, followed by the left eye without video. | Other: Video (played on a computer monitor)<br>* The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.<br>|
| Experimental: 1st: R eye no video. 2nd: L eye video<br>The right eye will be examined without video, followed by the left eye with video. | Other: Video (played on a computer monitor)<br>* The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.<br>|
| Experimental: 1st: L eye video. 2nd: R eye no video<br>The left eye will be examined first with video, followed by the right eye without video. | Other: Video (played on a computer monitor)<br>* The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.<br>|
| Experimental: 1st: L eye no video. 2nd: R eye video<br>The left eye will be examined first without video, followed by the right eye with video. | Other: Video (played on a computer monitor)<br>* The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of visualizing the optic disk within 60 seconds | 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. | At the time of fundoscopy exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the amount of time needed to visualize the optic disk. | 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. | 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. | 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). | At the time of fundoscopy exam | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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optic disk, fundoscopy, pediatric, clinical examination