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Painful Procedures in the Emergency Department: A Distraction Intervention (ERPain)
This study is currently recruiting participants.
Study NCT00338364   Information provided by IWK Health Centre
First Received: June 15, 2006   Last Updated: August 7, 2009   History of Changes

June 15, 2006
August 7, 2009
January 2006
October 2009   (final data collection date for primary outcome measure)
CAMPIS coding of visual pain response video-recorded during the procedure [ Time Frame: continuous ] [ Designated as safety issue: No ]
CAMPIS coding of visual pain response video-recorded during the procedure
Complete list of historical versions of study NCT00338364 on ClinicalTrials.gov Archive Site
  • Child pain ratings (Faces Pain Scale Revised) [ Time Frame: post procedure ] [ Designated as safety issue: No ]
  • Child anxiety ratings [ Time Frame: post procedure ] [ Designated as safety issue: No ]
  • CHEOPS analysis [ Time Frame: post procedure ] [ Designated as safety issue: No ]
  • Child pain ratings (Faces Pain Scale Revised)
  • Child anxiety ratings
  • CHEOPS analysis
 
Painful Procedures in the Emergency Department: A Distraction Intervention
Painful Procedures in the Emergency Department:Does a Formal Program in Distracting Techniques for Parents and Children Reduce Pain and Anxiety in Children?

This study is designed to assess the effectiveness of the video-based intervention over and above current standard practice for pain control in the pediatric emergency department (ED). This is a single-center trial based at the IWK Health Centre. The primary outcome will be based on the CAMPIS coding of the video-taped pain response of the research participants.

The purpose of this study is to determine if the pain and anxiety that children experience when they have venipuncture procedures performed can be reduced by a video-based distraction and coping strategy intervention. An instructional video has been designed to educate parents and children about what is going to happen during the venipuncture procedure; to teach coping skills that can be used before and during the painful procedure; and to provide distraction during the procedure by using an entertaining video segment.

Approximately 168 children (6-12 years of age)who are seen in the IWK ED requiring venipunctures for blood collection or IV starts will be randomized. PArent and child training in distraction and coping strategies will be provided by means of a self-administered video-delivery via a portable DVD player. Fifty percent of the eligible participants will receive the distraction and coping strategies intervention and 50% will receive the standard medical care provided by the IWK ED. Those receiving standard care will be evaluated for outcome results and then be compared to the intervention group. It is expected that children who receive the intervention will report less pain and anxiety associated with venipunctures than those who receive standard care.

Phase II
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Pediatric Pain and Anxiety
Behavioral: PAT
Coping and Distraction Intervention
  • Treatment: Experimental
    50% randomized to receive distraction during painful procedure
    Intervention: Behavioral: PAT
  • Control: No Intervention
    50% randomized to receive no distraction during painful procedure
    Intervention: Behavioral: PAT
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
168
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Participants will be eligible for this study if they:

  • are between 6-12 years of age
  • are presenting in the IWK Emergency Department who require a venipuncture for blood collection or IV initiation.
  • are able to read and speak english
  • provide written parental authorization and verbal child assent

Exclusion Criteria:

Participants will be excluded for this study if they:

  • are in critical condition as determined by ED staff
  • are in significant pain for other reasons other than the venipuncture
  • have severe cognitive delay
  • who require sedation for the venipuncture as determined by the ED staff
Both
6 Years to 12 Years
Yes
Contact: Patricia A. Lingley-Pottie, BNRN, CCRC (902) 470-7934 ext 7934 patricia.pottie@iwk.nshealth.ca
Contact: Michelle Patenaude (902) 470-6511 michelle.patenaude@iwk.nshealth.ca
Canada
 
NCT00338364
Patrick McGrath, IWK Health Centre/Dalhousie University
3202, Mayday grant
IWK Health Centre
The Mayday Foundation
Principal Investigator: Patrick J. McGrath, PhD. IWK Health Centre
IWK Health Centre
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP