跳至主要内容
临床试验/KCT0009201
KCT0009201已完成Unknown

Comparison of pain response, skin injury, hemostasis time, and facial expression in newborns after heel puncture using an auto,ated puncture device and a laser puncture device.

Inje University Haeundae Paik Hospital0 个研究点目标入组 84 人开始时间: 待定最近更新:
适应症

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
84

研究概览

简要总结

The results verified the differences in the percentage of skin injury(erythema, edema, bruise, scar) according to the puncture method used. Significantly different scars were observed in one case(2.9%) with the laser puncture device and seven case(18.9%) with the automated puncture device at 3 minutes after the puncture(?²=4.52, p=.033). One case(2.9%) with the laser puncture device and 31 cases(83.78%) with the automated puncture device were significantly different(?²=46.77, p< .001) 24 hours after the puncture. The number of punctures showed a significant difference according to the puncture method(t=7.94, p<.001). The laser puncture device(2.41±1.05) showed a higher number of punctures than the automatic puncture device(1.03±0.16). Hemostasis with the laser puncture device(1.12±0.03) was significantly lower(t= 8.61, p<.001) than that with the automated puncture device(1.84 ±0.37). Correlations between anger, contempt, disgust, fear, happiness, neutral, sadness, and surprise in pain behavioral response and facial expression analysis were also conducted. Significant positive correlations were observed between pain behavioral responses and anger(r=.24, p=.045), disgust (r=.27, p=.023), fear(r=.29, p=.015), and sadness(r=.25, p=.017) in facial expression analysis. In addition, facial expression in the subcategory of pain behavioral response showed a significant positive correlation with anger(r=.12, p=.031). Crying a subcategory of pain behavioral response showed significant positive correlations with fear(r=.28, p=.019) and sadness(r=.26, p=.031) in facial expression analysis. Finally, no significant differences in pain behavioral responses(F=2.09, p= .153), heart rate(F=0.09, p=.760), and oxygen saturation(F= 0.15, p=.705) were observed according to the puncture method.

研究设计

研究类型
Observational

入排标准

年龄范围
1(Day) 至 3(Month)(—)
性别
All

入选标准

  • The inclusion criteria for preterm babies were as follows: 1) gestational age of 32 - 37 weeks (moderate to late preterm baby based on the World Health Organization guideline), 2) requirement for blood sampling while in the NICU, 3) possible heel lance, 4) availability of hospital-approved blood sampling, and 5) written informed consent from the primary caregiver.

排除标准

  • The exclusion criteria were: 1) having a blood coagulation disorder and 2) receiving analgesia/sedatives or anticoagulants within 24 h prior to heel lance.

研究者

发起方
Inje University Haeundae Paik Hospital

相似试验