Pain Clinical Trial
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)?
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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