Sun Yongping, Zhang Jinghan, Chen Xu, Yang Yang, Qiu Jie, Lu Ke-Yu, Cheng Rui
Department of Neonates, Children's Hospital of Nanjing Medical University, Nanjing, China.
Front Pediatr. 2020 Dec 17;8:608378. doi: 10.3389/fped.2020.608378. eCollection 2020.
Retinopathy of pre-maturity (ROP) is a disorder of the retinal blood vessels in pre-term infants with low birth weight. It is a leading cause of blindness in children. During ROP screening, the use of mydriatic drops and eyelid openers causes pain and discomfort. Pain management strategies include medications and behavioral interventions. The objectives of this study was to investigate the effects of Gentle Human Touch on pain in pre-term infants undergoing screening for ROP. In this randomized controlled trial, 82 infants in the neonatal intensive care unit at Children's Hospital of Nanjing Medical University who met the ROP screening criteria were randomly assigned to experimental and control groups using the random number table. The infants in the experimental group continuously received Gentle Human Touch during screening, while those in the control group were screened according to the routine procedure. All neonates were administered local eye anesthesia before the screening. The degree of pain was assessed using the Pre-mature Infant Pain Profile score. A double-channel near-infrared spectroscopy device was used to monitor regional cerebral oxygen saturation (rScO), while oxygen saturation (SaO) and heart rate were measured using pulse oximetry. The Pre-mature Infant Pain Profile score was the primary outcome, while heart rate, SaO, and rScO were the secondary outcomes. The gestational age, corrected gestational age, birth weight, and Apgar score at examination and the basal heart rate, SaO, and rScO showed no significant intergroup differences ( > 0.05 for all). Both groups demonstrated significant decreases in SaO and rScO in response to the examination ( < 0.05 for all). During the examination, the Pre-mature Infant Pain Profile score (14.82 ± 3.22 vs. 9.29 ± 2.89, respectively; < 0.05) was significantly higher in the control group than in the experimental group, while rScO (57.61 ± 3.51 vs. 54.76 ± 4.54%, respectively; < 0.05) and SaO (91.89 ± 6.43 vs. 85.68 ± 8.31%; < 0.05) were significantly higher in the experimental group than in the control group. There was no significant difference in heart rate changes between the two groups before and after the examination (182.60 ± 3.50 vs. 170.80 ± 3.50 time/min; > 0.05). The findings of this study suggest that Gentle Human Touch can effectively alleviate pain during ROP screening in pre-mature infants. ISRCTN10976481, Registered 06 March 2020, Retrospectively registered.
早产儿视网膜病变（ROP）是一种发生于低体重早产儿视网膜血管的疾病。它是儿童失明的主要原因。在ROP筛查过程中，使用散瞳滴眼液和开睑器会引起疼痛和不适。疼痛管理策略包括药物治疗和行为干预。本研究的目的是调查温柔的人际接触对接受ROP筛查的早产儿疼痛的影响。在这项随机对照试验中，南京医科大学附属儿童医院新生儿重症监护病房中符合ROP筛查标准的82名婴儿，使用随机数字表随机分为实验组和对照组。实验组婴儿在筛查期间持续接受温柔的人际接触，而对照组婴儿按照常规程序进行筛查。所有新生儿在筛查前均接受局部眼部麻醉。使用早产儿疼痛量表评分评估疼痛程度。使用双通道近红外光谱仪监测局部脑氧饱和度（rScO），同时使用脉搏血氧仪测量血氧饱和度（SaO）和心率。早产儿疼痛量表评分是主要结局指标，心率、SaO和rScO是次要结局指标。两组婴儿的胎龄、矫正胎龄、出生体重、检查时的阿氏评分以及基础心率、SaO和rScO均无显著组间差异（均>0.05）。两组婴儿在检查后SaO和rScO均显著下降（均<0.05）。检查期间，对照组的早产儿疼痛量表评分（分别为14.82±3.22和9.29±2.89；<0.05）显著高于实验组，而实验组的rScO（分别为57.61±3.51和54.76±4.54%；<0.05）和SaO（分别为91.89±6.43和85.68±8.31%；<0.05）显著高于对照组。两组婴儿检查前后心率变化无显著差异（分别为182.60±3.50和170.80±3.50次/分钟；>0.05）。本研究结果表明，温柔的人际接触可有效减轻早产儿ROP筛查期间的疼痛。ISRCTN10976481，于2020年3月6日注册，回顾性注册。
