Objective The objective of the study was to assess the efficacy of immediate skin-to-skin care (SSC) versus swaddling in pain response to intramuscular injection of vitamin K at 30 min of birth in neonates. Methods Healthy full-term newborns were enrolled immediately after normal vaginal delivery and randomized in two groups, SSC and swaddling. Neonatal Infant Pain Scale (NIPS) was measured before, immediately after and at 2 min after the injection. Results Total 100 newborns were enrolled in the study (50 in each group). The mean (SD) birth weight of newborns in the SSC and swaddling group was 2668 (256) and 2730 (348) g, respectively. NIPS was comparable between the SSC and swaddling at before [1.78 (0.58) vs. 1.96 (0.83), p = 0.21], and immediately after the injection [4.82 (0.72) vs. 5.08 (0.75), p = 0.08]. NIPS at 2 min after the injection was significantly low in the SSC group compared to the swaddling group [1.38 (0.70) vs. 2.88 (1.00), p < 0.001]. At 2 min after injection, the NIPS score was significantly lower than baseline in the SSC group (p = 0.002), while it was significantly higher in the swaddling group (p < 0.001). A significantly higher proportion of newborns had a NIPS score of more than three at 2 min after injection in the swaddling group as compared to the SSC group (22% vs. 2%, p < 0.001). Conclusion Immediate SSC was more efficacious as compared to swaddling as a pain control intervention while giving vitamin K injection. Clinical Trial Registration The trial is registered with the Clinical Trial Registry of India with Registration number: CTRI/2020/01/022984.

中文翻译：

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皮肤对皮肤护理与襁褓对足月新生儿维生素 K 给药相关疼痛控制的疗效：一项随机对照试验

目的 该研究的目的是评估立即皮肤对皮肤护理 (SSC) 与襁褓对新生儿出生 30 分钟时肌肉注射维生素 K 的疼痛反应的疗效。方法 正常阴道分娩后立即纳入健康足月新生儿，随机分为SSC组和襁褓组。在注射前、注射后立即和注射后 2 分钟测量新生儿婴儿疼痛量表 (NIPS)。结果共有100名新生儿参加了研究（每组50名）。SSC 和襁褓组新生儿的平均 (SD) 出生体重分别为 2668 (256) 和 2730 (348) g。SSC 和襁褓之间的 NIPS 在 [1.78 (0.58) 与 1.96 (0.83)，p = 0.21] 之前和注射后立即 [4.82 (0.72) 与 5.08 (0.75)，p = 0.08] 之间具有可比性。与襁褓组相比，SSC 组注射后 2 分钟的 NIPS 显着降低 [1.38 (0.70) 与 2.88 (1.00)，p <; 0.001]。注射后 2 分钟，SSC 组的 NIPS 评分显着低于基线（p = 0.002），而襁褓组显着高于基线（p < 0.001）。与 SSC 组相比，襁褓组注射后 2 分钟 NIPS 评分超过 3 的新生儿比例显着高于 SSC 组（22% 对 2%，p < 0.001）。结论 在给予维生素 K 注射时，与襁褓作为一种疼痛控制干预措施相比，即刻 SSC 更有效。临床试验注册 该试验已在印度临床试验注册中心注册，注册号：CTRI/2020/01/022984。