Video Diversion During Fundoscopic Exam in Children (CAFE)
28. april 2026 opdateret af: Ash Singhal, University of British Columbia
Video Diversion During Fundoscopic Exam in Children: A Randomized Controlled Trial
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- BC Children's Hospital
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 år til 8 år (Barn)
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.
|
|
Eksperimentel: 1st: R eye no video. 2nd: L eye video
The right eye will be examined without video, followed by the left eye with video.
|
The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.
|
|
Eksperimentel: 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.
|
The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.
|
|
Eksperimentel: 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.
|
The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Success rate of visualizing the optic disk within 60 seconds
Tidsramme: At the time of fundoscopy exam
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Reduction in the amount of time needed to visualize the optic disk.
Tidsramme: At the time of fundoscopy exam
|
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.
Tidsramme: 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 as determined by a 10 point likert scale (1 being easiest and 10 being hardest).
|
At the time of fundoscopy exam
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ash Singhal, MD, University of British Columbia
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Jan MM. Neurological examination of difficult and poorly cooperative children. J Child Neurol. 2007 Oct;22(10):1209-13. doi: 10.1177/0883073807306262.
- Cok OY. Anaesthesia for eye examination. Current Anaesthesia & Critical Care 2008 February 2009;20(1):46.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2011
Primær færdiggørelse (Faktiske)
1. marts 2012
Studieafslutning (Faktiske)
1. august 2012
Datoer for studieregistrering
Først indsendt
20. august 2012
Først indsendt, der opfyldte QC-kriterier
23. august 2012
Først opslået (Anslået)
28. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. april 2026
Sidst verificeret
1. august 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H11-01885
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .