Objective This study examined the impact of a humanoid robot (MEDi®) programmed to teach deep breathing as a coping strategy, on children’s pain and fear as primary and secondary outcomes, respectively, during intravenous (IV) line placement. The completion of IV induction was also examined as an exploratory outcome. Methods In this randomized controlled, two-armed trial, 137 children (4–12 years) were recruited in Short Stay Surgery at a tertiary pediatric hospital. Patients were randomly assigned to standard care (SC) with Ametop© only (N = 60) or SC and robot-facilitated intervention (N = 59) before induction. Pain and fear before, during, and after IV insertion were rated by patients and observers. Results No significant differences were found between groups and there were no changes over time for pain or fear (ps > .05). Exploratory analyses show that patients in the MEDi® group were 5.04 times more likely to complete IV induction, compared to SC, Fisher’s exact test: X2 (1) = 4.85, p = .04, φc = 0.22, odds ratio = 5.04, 95% CI [1.06, 24.00]. Conclusion This study was the first to examine children’s IV induction experience when provided MEDi® support. Reasons for nonsignificance, limitations, and research suggestions were made.

中文翻译：

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IV 诱导期间儿童的疼痛：MEDi® 机器人的随机对照试验

目的 本研究检查了人形机器人 (MEDi®) 编程以教授深呼吸作为一种应对策略，在静脉 (IV) 管线放置期间，儿童疼痛和恐惧分别作为主要和次要结果的影响。IV 诱导的完成也作为探索性结果进行了检查。方法 在这项随机对照、两臂试验中，招募了 137 名儿童（4-12 岁）在一家三级儿科医院进行短期住院手术。患者在诱导前被随机分配到仅使用 Ametop© 的标准护理 (SC) (N = 60) 或 SC 和机器人辅助干预 (N = 59)。患者和观察者对静脉注射之前、期间和之后的疼痛和恐惧进行评分。结果 两组之间没有发现显着差异，并且疼痛或恐惧没有随时间变化（ps > .05）。探索性分析表明，与 SC、Fisher 精确检验相比，MEDi® 组患者完成 IV 诱导的可能性高 5.04 倍：X2 (1) = 4.85，p = .04，φc = 0.22，优势比 = 5.04, 95 % CI [1.06, 24.00]。结论 本研究首次检验了提供 MEDi® 支持时儿童的 IV 诱导体验。提出了不显着的原因、局限性和研究建议。