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Reducing Immunization Distress (RID)

University of California, San Francisco · 2011
ClinicalTrials.gov · Datasets · License: Public Domain · 2011
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The purpose of this study is to compare the effectiveness of a more feasible method for reducing the pain and distress of childhood immunization with the standard method in use at the Pediatric Medical Group. A secondary aim is to evaluate the impact of parental involvement on the parent and child satisfaction with the immunization experience. Study Hypotheses: In the standard, pre-kindergarten, two- or three vaccine sequence, there will be no statistically significant group differences between PPT and ST with respect to: 1. Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale13 (primary outcome); 2. Parent report of child pain using the FPS-R; 3. Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale14; 4. Parent and child satisfaction with pain management during immunization measured by a 5-point Likert type scales; 5. Time required for completion of immunization from initiation of ST or PPT to 2 minutes after completion of the last injection.
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