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Clinical Trials/NCT00338364
NCT00338364
Completed
Phase 2

Painful Procedures in the Emergency Department:Does a Formal Program in Distracting Techniques for Parents and Children Reduce Pain and Anxiety in Children?

IWK Health Centre1 site in 1 country189 target enrollmentJanuary 2006

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Pediatric Pain and Anxiety
Sponsor
IWK Health Centre
Enrollment
189
Locations
1
Primary Endpoint
CAMPIS coding of visual pain response video-recorded during the procedure
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
August 2009
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

CAMPIS coding of visual pain response video-recorded during the procedure

Time Frame: continuous

Secondary Outcomes

  • Child pain ratings (Faces Pain Scale Revised)(post procedure)
  • Child anxiety ratings(post procedure)
  • CHEOPS analysis(post procedure)

Study Sites (1)

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