Clinical trial NCT01673815: Video Diversion During Fundoscopic Exam in Children
Official title: Video Diversion During Fundoscopic Exam in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Disorders of Optic Disc, Bilateral
Keywords: optic disk
fundoscopy
pediatric
clinical examination
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Success rate of visualizing the optic disk within 60 seconds
timeFrame: At the time of fundoscopy exam
Secondary outcomes:
measure: Reduction in the amount of time needed to visualize the optic disk.
timeFrame: At the time of fundoscopy exam
measure: Improvement in the physician's and caregiver's (parent/legal guardian) perception of the ease of the fundoscopic exam.
timeFrame: At the time of fundoscopy exam
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ash Singhal, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Cok OY. Anaesthesia for eye examination. Current Anaesthesia & Critical Care 2008 February 2009;20(1):46.
citation: de la Barra F, Toledo V, Rodriguez J. Prediction of behavioral problems in Chilean schoolchildren. Child Psychiatry Hum Dev. 2005 Spring;35(3):227-43. doi: 10.1007/s10578-004-6459-9.
citation: Colares V, Richman L. Factors associated with uncooperative behavior by Brazilian preschool children in the dental office. ASDC J Dent Child. 2002 Jan-Apr;69(1):87-91, 13.
citation: Hussein MA, Coats DK, Paysse EA. Use of the RetCam 120 for fundus evaluation in uncooperative children. Am J Ophthalmol. 2004 Feb;137(2):354-5. doi: 10.1016/S0002-9394(03)00867-5.