A randomized controlled trial of the ShotBlocker for children's immunization distress.

OBJECTIVES Vaccinations protect children against deadly diseases and approximately 30 immunizations are recommended for children by 6 years of age. However, immunization injections cause negative short-term and long-term consequences for children. The Gate Control Theory of pain suggests that physical interventions (eg, rubbing the site) may be helpful, but they are not well validated for children's acute pain. This randomized trial examined the effectiveness of the ShotBlocker, a physical intervention designed to decrease children's injection pain. METHODS Participants included 89 4- to 12-year-old children receiving immunizations at a pediatric practice. Participants were randomized to ShotBlocker, placebo control, or typical care control groups. Measures of child distress included self-report, parent report, healthcare provider report, change in heart rate, and observational behavioral coding. RESULTS No group differences were evident on any of the measures of child pain or anxiety when controlling for child age, nor were there any significant interactions of treatment condition with child age. On the observational distress measure, analysis of covariances revealed significantly higher distress in the injection than preinjection or postinjection phases, and postinjection distress was higher than preinjection phase distress, irrespective of treatment condition. DISCUSSION The data do not support the effectiveness of the ShotBlocker for acute pediatric pain relief. Clinical and theoretical implications are discussed.