Painful Procedures in the Emergency Department: A Distraction Intervention (ERPain)
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ClinicalTrials.gov Identifier: NCT00338364 |
Recruitment Status
:
Completed
First Posted
: June 20, 2006
Last Update Posted
: September 12, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pediatric Pain and Anxiety | Behavioral: PAT | Phase 2 |
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 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 |

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
|
- CAMPIS coding of visual pain response video-recorded during the procedure [ Time Frame: continuous ]
- Child pain ratings (Faces Pain Scale Revised) [ Time Frame: post procedure ]
- Child anxiety ratings [ Time Frame: post procedure ]
- CHEOPS analysis [ Time Frame: post procedure ]

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

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
Canada, Nova Scotia | |
IWK Health Centre | |
Halifax, Nova Scotia, Canada, B3K 6R8 |
Principal Investigator: | Patrick J. McGrath, PhD. | IWK Health Centre |
Responsible Party: | IWK Health Centre |
ClinicalTrials.gov Identifier: | NCT00338364 History of Changes |
Other Study ID Numbers: |
3202 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 pain Pediatric anxiety Painful procedures |
Additional relevant MeSH terms:
Anxiety Disorders Emergencies Mental Disorders Disease Attributes Pathologic Processes |