Painful Procedures in the Emergency Department: A Distraction Intervention (ERPain)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00338364

First Posted: June 20, 2006

Last Update Posted: September 12, 2013

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.

Collaborator:

Mayday Fund

Information provided by (Responsible Party):

IWK Health Centre

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 CAMPIS coding of the video-taped pain response of the research participants.

Condition	Intervention	Phase
Pediatric Pain and Anxiety	Behavioral: PAT	Phase 2


Study Type:	Interventional
Study Design:	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?

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

Child pain ratings (Faces Pain Scale Revised) [ Time Frame: post procedure ]
Child anxiety ratings [ Time Frame: post procedure ]
CHEOPS analysis [ Time Frame: post procedure ]


Enrollment:	189
Study Start Date:	January 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 during painful procedure	Behavioral: PAT Coping and Distraction Intervention
No Intervention: Control 50% randomized to receive no distraction during painful procedure

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	6 Years to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00338364

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


Responsible Party:	IWK Health Centre
ClinicalTrials.gov Identifier:	NCT00338364 History of Changes
Other Study ID Numbers:	3202 Mayday grant
First Submitted:	June 15, 2006
First Posted:	June 20, 2006
Last Update Posted:	September 12, 2013
Last Verified:	September 2013

Keywords provided by IWK Health Centre:


Pediatric pain Pediatric anxiety Painful procedures

Additional relevant MeSH terms:


Anxiety Disorders Emergencies Mental Disorders Disease Attributes Pathologic Processes

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