There is growing evidence that children who experience inadequate pain control during medical procedures may suffer long lasting effects research has demonstrated that cognitive behavioral interventions are effective in reducing pain and distress behavior for some, but not all, children during medical procedures. Cost effectiveness and parental interest have resulted in research on parental coaching of children in the use of cognitive behavioral interventions during painful medical procedures. Research is needed to determine which children benefit from cognitive behavioral interventions and under what circumstances. This research will identify factors that predict which children benefit from and which parents can effectively provide distraction to alleviate the child's behavioral distress during a medical procedure. This will guide the development of a clinically relevant predictive distress profile. The specific study aims are to: 1) determine the effectiveness of training parents to be distraction coaches during a medical procedure (intravenous insertion) by comparing responses of parents and children who receive the training (experimental group) with those who do not (control group); 2) identify parent and child characteristics predictive of children who respond with low versus high indicators of distress following parent delivered distraction during a painful medical procedure; and 3) determine the relationships and interactions among study variables that are associated with low versus high distress in children following a parent delivered distraction during a painful medical procedure. Approximately 540 children scheduled for an IV insertion for a medical test and their parents from 3 children's hospitals will be randomly assigned to an experimental or control group. The distraction intervention will be taught to families in the experimental group. The operational definition of distraction includes: reading to the child, pointing out specific items in books, talking to the child about non-procedure related topics, telling stories, blowing bubbles, finger play or using toys to capture the child's attention. Child and parent characteristics will be assessed to describe and define how each impacts the child response to the intervention and the medical procedure. Parent success response will be measured with self-assessment of success and observation of performance of distraction. Logistic regression will be used to develop the predictive models.
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