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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Pediatric Pain and Anxiety	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 (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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	189 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?
Study Start Date :	January 2006
Actual Primary Completion Date :	August 2009
Actual Study Completion Date :	August 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	IWK Health Centre
ClinicalTrials.gov Identifier:	NCT00338364 History of Changes
Other Study ID Numbers:	3202; Mayday grant
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