Video Diversion During Fundoscopic Exam in Children

NCT ID: NCT01673815

Last Updated: 2012-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-08-31

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.

Conditions

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Other Disorders of Optic Disc, Bilateral

Keywords

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optic disk fundoscopy pediatric clinical examination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

Video (played on a computer monitor)

Intervention Type OTHER

The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.

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

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

Group Type EXPERIMENTAL

Video (played on a computer monitor)

Intervention Type OTHER

The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.

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

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

Group Type EXPERIMENTAL

Video (played on a computer monitor)

Intervention Type OTHER

The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.

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

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

Group Type EXPERIMENTAL

Video (played on a computer monitor)

Intervention Type OTHER

The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.

Interventions

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Video (played on a computer monitor)

The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.

Intervention Type OTHER

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ash Singhal, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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BC Children's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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Jan MM. Neurological examination of difficult and poorly cooperative children. J Child Neurol. 2007 Oct;22(10):1209-13. doi: 10.1177/0883073807306262.

Reference Type BACKGROUND
PMID: 17940248 (View on PubMed)

Cok OY. Anaesthesia for eye examination. Current Anaesthesia & Critical Care 2008 February 2009;20(1):46.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 15731888 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12119822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14962432 (View on PubMed)

Other Identifiers

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H11-01885

Identifier Type: -

Identifier Source: org_study_id