A Test of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain
| Status: | Archived |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2010 |
| End Date: | September 2011 |
Phase II Study of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain in Multiple Age Groups
The hypothesis of this study is that distraction cards used by the caretaker along with a
vibrating cold pack placed proximal to the site of immunization will decrease the pain of
routine pediatric immunizations when compared to a placebo device or standard care.
Needle pain is the most common and the most feared source of childhood pain, resulting in
needle phobia for 10$ of adults. Current standard of care for immunizations in the US is no
pain relief. An inexpensive, immediately effective form of needle pain control could reduce
needle phobia or vaccine refusal in the long term if demonstrated to be effective for
immunization pain.
Distraction can decrease procedural distress in children by 50%. The effect of using a
multi-modal pain and distraction relieving approach has not been rigorously studied.
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