Video Diversion During Fundoscopic Exam in Children (CAFE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01673815
First received: August 20, 2012
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Other Disorders of Optic Disc, Bilateral
Other: Video (played on a computer monitor)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Video Diversion During Fundoscopic Exam in Children: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Success rate of visualizing the optic disk within 60 seconds [ Time Frame: At the time of fundoscopy exam ] [ Designated as safety issue: No ]
    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:
  • Reduction in the amount of time needed to visualize the optic disk. [ Time Frame: At the time of fundoscopy exam ] [ Designated as safety issue: No ]
    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. [ Time Frame: At the time of fundoscopy exam ] [ Designated as safety issue: No ]
    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).


Enrollment: 60
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: 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.
Experimental: 1st: R eye no video. 2nd: L eye video
The right eye will be examined without video, followed by the left eye with video.
Other: 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.
Experimental: 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.
Other: 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.
Experimental: 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.
Other: 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.

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

Ages Eligible for Study:   1 Year to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673815

Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Ash Singhal, MD University of British Columbia
  More Information

Publications:
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01673815     History of Changes
Other Study ID Numbers: H11-01885
Study First Received: August 20, 2012
Last Updated: August 23, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
optic disk
fundoscopy
pediatric
clinical examination

Additional relevant MeSH terms:
Optic Disk Drusen
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014