Department of Psychology, Georgia State University, Atlanta, 30302-5010, USA.
Clin J Pain. 2009 Nov-Dec;25(9):790-6. doi: 10.1097/AJP.0b013e3181af1324.
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.
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.
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.
The data do not support the effectiveness of the ShotBlocker for acute pediatric pain relief. Clinical and theoretical implications are discussed.
疫苗可预防儿童罹患致命疾病，建议儿童在 6 岁前接种约 30 种疫苗。然而，免疫接种会给儿童带来短期和长期的负面影响。疼痛的闸门控制理论表明，身体干预（如按摩注射部位）可能会有所帮助，但针对儿童急性疼痛的效果尚未得到充分验证。本随机试验研究了 ShotBlocker 的有效性，这是一种旨在减轻儿童注射疼痛的身体干预措施。
参与者包括在儿科诊所接受免疫接种的 89 名 4 至 12 岁儿童。参与者被随机分配到 ShotBlocker 组、安慰剂对照组或常规护理对照组。儿童痛苦的测量包括自我报告、父母报告、医疗保健提供者报告、心率变化和观察行为编码。
在控制儿童年龄的情况下，各组在儿童疼痛或焦虑的任何测量指标上均无差异，治疗条件与儿童年龄之间也没有显著的交互作用。在观察性痛苦测量中，协方差分析显示，注射阶段的痛苦明显高于注射前和注射后阶段，而注射后阶段的痛苦高于注射前阶段，无论治疗条件如何。
数据不支持 ShotBlocker 对缓解儿童急性疼痛的有效性。讨论了临床和理论意义。
