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
  Purpose

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).


Condition Intervention Phase
Anxiety
Pain
Behavioral: PAT
Phase 2

Study Type: Interventional
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)?

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • CAMPIS coding of visual pain response video-recorded during the procedure [ Time Frame: continuous ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 131
Study Start Date: March 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
50% randomized to receive distraction intervention during painful procedure
Behavioral: PAT
Cognitive-Behavioral/Relaxation Intervention
No Intervention: Control
50% RANDOMIZED TO RECEIVE NO INTERVENITON

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 (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.

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337870

Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Mayday Fund
Investigators
Principal Investigator: Patrick J McGrath, PhD. IWK Health Centre
  More Information

No publications provided

Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT00337870     History of Changes
Other Study ID Numbers: 3416, Mayday grant
Study First Received: June 15, 2006
Last Updated: September 11, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by IWK Health Centre:
Pediatric Anxiety
Pediatric Pain
Emergency room procedures

Additional relevant MeSH terms:
Anxiety Disorders
Emergencies
Mental Disorders
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014