Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds) (ERPain)

This study has been completed.
Sponsor:
Collaborator:
Mayday Fund
Information provided by (Responsible Party):
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00337870
First received: June 15, 2006
Last updated: September 11, 2013
Last verified: September 2013

June 15, 2006
September 11, 2013
March 2006
August 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 NCT00337870 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Parental reports of:
  • Child pain ratings (Faces Pain Scale Revised)
  • Child anxiety ratings
  • CHEOPS analysis
Not Provided
Not Provided
 
Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds)
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)?

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anxiety
  • Pain
Behavioral: PAT
Cognitive-Behavioral/Relaxation Intervention
  • Experimental: Treatment
    50% randomized to receive distraction intervention during painful procedure
    Intervention: Behavioral: PAT
  • No Intervention: Control
    50% RANDOMIZED TO RECEIVE NO INTERVENITON
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Participants will be eligible for this study if they:

  • Are between 3-5 years of age
  • Are presenting in the IWK Emergency Department requiring venipuncture for blood collection or intravenous (IV) initiation.
  • Are able to read and speak English
  • Provide written parental authorization

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
  • Require sedation for the venipuncture as determined by the ED staff
Both
3 Years to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00337870
3416, Mayday grant
No
IWK Health Centre
IWK Health Centre
Mayday Fund
Principal Investigator: Patrick J McGrath, PhD. IWK Health Centre
IWK Health Centre
September 2013

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