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Sponsors and Collaborators: |
IWK Health Centre The Mayday Foundation |
Information provided by: | IWK Health Centre |
ClinicalTrials.gov Identifier: | NCT00337870 |
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 | Intervention | Phase |
Anxiety Pain |
Behavioral: Cognitive-Behavioral/Relaxation Intervention |
Phase II |
MedlinePlus related topics: | Anxiety |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
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)? |
Estimated Enrollment: | 168 |
Study Start Date: | March 2006 |
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.
Ages Eligible for Study: | 3 Years to 5 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:
Contact: Patricia A. Lingley-Pottie, BNRN, CCRC | (902) 470-7934 | patricia.pottie@iwk.nshealth.ca |
Contact: Elizabeth Coffin | (902) 470-8760 | elizabeth.coffin@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 patricia.pottie@iwk.nshealth.ca | |||||
Contact: Elizabeth Coffin (902) 470-8760 elizabeth.coffin@iwk.nshealth.ca | |||||
Principal Investigator: Patrick J. McGrath, PhD. |
IWK Health Centre |
The Mayday Foundation |
Principal Investigator: | Patrick J McGrath, PhD. | IWK Health Centre |
Study ID Numbers: | 3416 |
First Received: | June 15, 2006 |
Last Updated: | January 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00337870 |
Health Authority: | Canada: Ethics Review Committee |
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