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| Sponsor: | IWK Health Centre |
|---|---|
| Collaborator: |
The Mayday Foundation |
| Information provided by: | IWK Health Centre |
| ClinicalTrials.gov Identifier: | NCT00338364 |
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 II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Active Control 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? |
| Estimated Enrollment: | 168 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment: Experimental
50% randomized to receive distraction during painful procedure
|
Behavioral: PAT
Coping and Distraction Intervention
|
|
Control: No Intervention
50% randomized to receive no distraction during painful procedure
|
Behavioral: PAT
Coping and Distraction Intervention
|
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| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Participants will be eligible for this study if they:
Exclusion Criteria:
Participants will be excluded for this study if they:
Contacts and Locations| Contact: Patricia A. Lingley-Pottie, BNRN, CCRC | (902) 470-7934 ext 7934 | patricia.pottie@iwk.nshealth.ca |
| Contact: Michelle Patenaude | (902) 470-6511 | michelle.patenaude@iwk.nshealth.ca |
| Canada, Nova Scotia | |
| IWK Health Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Contact: Patricia A. Lingley-Pottie, BNRN, CCRC (902) 470-7934 ext 7934 patricia.pottie@iwk.nshealth.ca | |
| Contact: Michelle Patenaude (902) 470-6511 michelle.patenaude@iwk.nshealth.ca | |
| Principal Investigator: Patrick J. McGrath, PhD. | |
| Principal Investigator: | Patrick J. McGrath, PhD. | IWK Health Centre |
More Information
| Responsible Party: | IWK Health Centre/Dalhousie University ( Patrick McGrath ) |
| Study ID Numbers: | 3202, Mayday grant |
| Study First Received: | June 15, 2006 |
| Last Updated: | August 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00338364 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
|
Pediatric pain Pediatric anxiety Painful procedures |
|
Disease Attributes Pathologic Processes Emergencies |