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Completed

NCT Number: NCT00338364

Painful Procedures in the Emergency Department: A Distraction Intervention

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAT

Behavioral

Coping and Distraction Intervention

Primary outcomes

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

    Time frame: continuous

Secondary outcomes

  1. Child pain ratings (Faces Pain Scale Revised)

    Time frame: post procedure

  2. Child anxiety ratings

    Time frame: post procedure

  3. CHEOPS analysis

    Time frame: post procedure

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Collaborators

  • Mayday Fund

Registry information

Official study title

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

Acronym: ERPain

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 20, 2006
Registry last updated
Sep 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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