Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds) (ERPain)
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 Child-Adult Medical Procedures Interaction Scale (CAMPIS) coding of the video-taped pain response of the research participants (3-5 years old).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Painful Procedures in the Emergency Department: Does a Formal Program in Distracting Techniques for Parents and Children Reduce Pain and Anxiety in Children (3-5 Year Olds)?|
- CAMPIS coding of visual pain response video-recorded during the procedure [ Time Frame: continuous ] [ Designated as safety issue: No ]
- Parental reports of: 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 ]
|Study Start Date:||March 2006|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
50% randomized to receive distraction intervention during painful procedure
No Intervention: Control
50% RANDOMIZED TO RECEIVE NO INTERVENITON
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 (3-5 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.
|Canada, Nova Scotia|
|IWK Health Centre|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Principal Investigator:||Patrick J McGrath, PhD.||IWK Health Centre|