Video Diversion Improves Success Rate of Fundoscopic Examination in Children

NCT ID: NCT02784132

Last Updated: 2016-05-26

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

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-06-30

Brief Summary

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Fundoscopy is an important component of the neurological examination as it can detect pathologies such as high intracranial pressure. However, the exam can be challenging in uncooperative children. This study looked at whether playing a video during eye examination, improves the success, duration and ease of pediatric fundoscopy.

Detailed Description

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Fundoscopy is an important component of the neurological examination as it can detect pathologies such as high intracranial pressure. However, the exam can be challenging in uncooperative children. This study looked at whether playing a video during eye examination, improves the success, duration and ease of pediatric fundoscopy. The authors plan to recruit from 4 different clinical care settings for a total of 101 subjects. Success rate is defined as visualizing the optic disc within 60 seconds from commencement of fundoscopy. The ease of examination is determined by using a 10 point likert scale.

Conditions

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Fundoscopy

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Arm A

Right eye examined first with video diversion then left eye examined without video diversion

Group Type OTHER

Video diversion

Intervention Type OTHER

The intervention is playing a video on a computer or iPad (using www.youtube.com) while performing fundoscopy.

Study Arm B

Right eye examined first without video diversion then left eye examined with video diversion

Group Type OTHER

Video diversion

Intervention Type OTHER

The intervention is playing a video on a computer or iPad (using www.youtube.com) while performing fundoscopy.

Study Arm C

Left eye examined first with video diversion then right eye examined without video diversion

Group Type OTHER

Video diversion

Intervention Type OTHER

The intervention is playing a video on a computer or iPad (using www.youtube.com) while performing fundoscopy.

Study Arm D

Left eye examined first without video diversion then right eye examined with video diversion

Group Type OTHER

Video diversion

Intervention Type OTHER

The intervention is playing a video on a computer or iPad (using www.youtube.com) while performing fundoscopy.

Interventions

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Video diversion

The intervention is playing a video on a computer or iPad (using www.youtube.com) while performing fundoscopy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patient aged 1 to 4 years of age (inclusive) with 2 examinable eyes

Exclusion Criteria

* Patients who were blind, younger than 1 year of age, or older than 4 years of age
Minimum Eligible Age

1 Year

Maximum Eligible Age

4 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, Dr.

Role: PRINCIPAL_INVESTIGATOR

The 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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Yang MMH, Singhal A, Hengel AR, Kerr JM, St-Pierre GH, George S, Muir K, Thiessen P, Enarson P. Video Diversion Improves Success Rate of Fundoscopic Examination in Children: A Prospective Randomized Controlled Trial. Pediatr Neurol. 2018 Jun;83:32-37. doi: 10.1016/j.pediatrneurol.2017.09.008. Epub 2017 Sep 14.

Reference Type DERIVED
PMID: 29681489 (View on PubMed)

Other Identifiers

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H12-02053

Identifier Type: -

Identifier Source: org_study_id

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