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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00337870
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : September 12, 2013
Mayday Fund
Information provided by (Responsible Party):
IWK Health Centre

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 Child-Adult Medical Procedures Interaction Scale (CAMPIS) coding of the video-taped pain response of the research participants (3-5 years old).

Condition or disease Intervention/treatment Phase
Anxiety Pain Behavioral: PAT Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)?
Study Start Date : March 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Treatment
50% randomized to receive distraction intervention during painful procedure
Behavioral: PAT
Cognitive-Behavioral/Relaxation Intervention

No Intervention: Control

Primary Outcome Measures :
  1. CAMPIS coding of visual pain response video-recorded during the procedure [ Time Frame: continuous ]

Secondary Outcome Measures :
  1. Parental reports of: 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00337870

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

Responsible Party: IWK Health Centre Identifier: NCT00337870     History of Changes
Other Study ID Numbers: 3416
Mayday grant
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: September 12, 2013
Last Verified: September 2013

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

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