背景:由于医疗程序,早产儿有很高的疼痛副作用风险。在这方面,足跟穿刺毛细血管采血是一种常见的痛苦过程。进行本研究是为了评估模拟的宫内声音对早产儿因足跟刺血采样引起的疼痛的行为和生理指标的有效性。
方法:进行了一项双盲随机临床试验(RCT)。数据收集时间为2019年9月23日至12月22日。我们测量了模拟宫内声音对疼痛行为和生理参数变化的影响(心率,SPO2)由干预前5分钟测量的脚跟喷枪引起,在采样过程中,手术后5分钟。我们通过记录婴儿面部的视频和新生儿疼痛评分(NIPS)来测量行为疼痛。使用脉搏血氧计装置测量心率和SPO2。在SPSS软件20.0版中使用方差分析(ANOVA)和独立t检验对数据进行分析。
结果:将80名婴儿随机分组(每组40名)。干预组干预期间和干预后的平均NIPS得分(3.55±0.84,95%CI:3.30-3.80(,分别为(1.15±0.84,95%:0.95-1.35)和对照组(5.57±0.95,95%CI:5.30-5.85)和(3.00±0.98)。在足跟穿刺后5分钟(p<0.001)和5分钟(p<0.001),两个研究组之间的NIPS评分存在显着差异。前三个阶段的心率平均得分,during,干预后5分钟干预组分别为(127.57±4.45,95%CI:126.27~128.99),(131.07±6.54,95%CI:129.20-133.22),(128.45±5.15,95%CI:127.02-130.07)和对照组(128.67±4.57,95%CI:127.32-130.07),(136.07±7.24,95%CI:133.90-138.37),和(132.42±6.47,95%CI:130.37-134.49)。干预组和对照组在足跟枪后5分钟(p=0.002)和5分钟(p=0.003)的心率存在显着差异。基线三个阶段的SPO2平均得分,during,干预后5min,干预组分别为96.72±0.93,95%CI:96.42~97.00,(91.47±1.46,95%CI:91.05-91.92),(94.17±1.03,95%CI:93.22-94.00)和对照组(96.6±0.84,95%CI:96.35-96.85),(91.5±1.24,95%CI:91.12-91.87),和(93.60±1.27,95%CI:93.85-94.50)。
结论:这项研究表明,模拟的宫内声音降低了干预组在足跟刺激期间和之后的行为疼痛和心率。这些结果表明,在疼痛的足跟穿刺过程中使用该方法来减少早产儿的疼痛参数。
BACKGROUND: Due to medical procedures, preterm infants are at high risk for side effects of pain. In this regard, heel lancing for capillary blood sampling is a common painful procedure. The present
study was conducted to assess the effectiveness of a simulated intrauterine sound on behavioral and physiological indices of pain due to heel-prick blood sampling in preterm infants.
METHODS: A double‑blind randomized clinical
trial (RCT) was conducted. The data were collected from September 23 to December 22, 2019. We measured the effect of a simulated intrauterine sound on changes in the behavioral and physiological parameters of pain (heart rate, SPO2) caused by heel lance that was measured 5 min before the intervention, during the sampling, and 5 min after the procedure. We measured behavioral pain by video recording the infants\' faces and then the scoring neonatal infant pain scale (NIPS). Heart rate and SPO2 were measured using a pulse oximeter device. The data were analyzed using analysis of variance (ANOVA) and independent t‑test in SPSS software version 20.0.
RESULTS: Eighty infants were randomized (40 in each group). Mean scores NIPS during and after intervention were in the intervention group (3.55 ± 0.84, 95% CI: 3.30-3.80(, and (1.15 ± 0.84, 95%: 0.95-1.35) and in the control group (5.57 ± 0.95, 95% CI:5.30-5.85) and (3.00 ± 0.98) respectively. There were significant differences in scores of NIPS between the two
study groups during (p < 0.001) and five min after
heel lancing (p < 0.001). Mean scores of heart rate in the three phases of before, during, and five min after the intervention were respectively in the intervention group (127.57 ± 4.45, 95% CI:126.27-128.99), (131.07 ± 6.54, 95% CI:129.20-133.22), (128.45 ± 5.15, 95% CI:127.02-130.07) and in the control group (128.67 ± 4.57, 95% CI:127.32-130.07), (136.07 ± 7.24, 95% CI:133.90-138.37), and (132.42 ± 6.47, 95% CI:130.37-134.49). There were significant differences in heart rate between the intervention and the control group during (p = 0.002) and five min after the heel lance (p = 0.003). Mean scores of SPO2 in the three phases of baseline, during, and five min after the intervention were respectively in the intervention group (96.72 ± 0.93, 95% CI:96.42-97.00), (91.47 ± 1.46, 95% CI:91.05-91.92), (94.17 ± 1.03, 95% CI:93.22-94.00) and in the control group (96.6 ± 0.84, 95% CI:96.35-96.85), (91.5 ± 1.24, 95% CI:91.12-91.87), and (93.60 ± 1.27, 95% CI:93.85-94.50).
CONCLUSIONS: This
study showed that the simulated intrauterine sound reduces the behavioral pain and heart rate in the intervention group during and after heel lance. These results suggest using the method during the painful heel lancing to reduce pain parameters in preterm infants.