白噪声干预对新生儿操作性疼痛影响的随机对照研究

Effects of white noise on procedural pain-related cortical response and pain score in neonates:A randomized controlled trial

目的评价白噪声干预对新生儿操作性疼痛相关脑皮质反应、疼痛评分、行为表现及生理指标的影响。方法本研究为随机对照双盲试验。将某大学附属综合医院新生儿重症监护病房的66例新生儿随机分为2组,桡动脉穿刺采血前2 min至拔针后5 min为其播放白噪声(试验组50 dB,对照组0 dB)。疼痛相关脑皮质反应采用近红外光谱仪测量新生儿局部脑组织血氧饱和度(regional cerebral oxygen saturation,rScO_(2)),使用2台摄像机分别静音摄录患儿面部表情和监测仪生理参数视频。2名评估者回放视频,使用修订版早产儿疼痛评分量表(Premature Infant Pain Profile-Revised,PIPP-R)独立评估患儿疼痛评分。主要结局指标为穿刺期间及拔针后5 min内PIPP-R评分和rScO_(2)。次要结局指标为穿刺期间SpO_(2)、心率,以及痛苦表情持续时间。结果共60例新生儿(试验组29例,对照组31例)纳入结果分析。试验组与对照组最高PIPP-R评分分别为12.00(9.50,13.00)分、12.50(10.50,13.75)分,最低rScO_(2)分别为(61.22±3.07)%、(61.32±2.79)%,差异均无统计学意义。动脉穿刺期间平均rScO_(2)、心率、SpO_(2)组间无差异。拔针后,两组患儿rScO_(2)、PIPP-R评分及面部表情恢复速度不同,但差异无统计学意义。结论白噪声干预对新生儿操作性疼痛相关脑皮质反应以及疼痛评分、行为、生理指标未表现出有益效果。

Objectives To evaluate the effects of white noise on pain-related cortical response,pain score,and behavioral and physiological parameters in neonates with procedural pain.Methods A double-blind,randomized controlled trial was conducted.Sixty-six neonates from the Neonatal Intensive Care Unit in a university-affiliated general hospital were randomly assigned to listen to white noise at 50 dB(experimental group)or 0 dB(control group)2 min before radial artery blood sampling and continued until 5 min after needle withdrawal.Pain-related cortical response was measured by regional cerebral oxygen saturation(rScO_(2))monitored with near-infrared spectroscopy,and facial expressions and physiological parameters were recorded by two video cameras.Two assessors scored the Premature Infant Pain Profile-Revised(PIPP-R)independently when viewing the videos.Primary outcomes were pain score and rScO_(2)during arterial puncture and 5 min after needle withdrawal.Secondary outcomes were pulse oximetric oxygen saturation(SpO_(2))and heart rate(HR)during arterial puncture,and duration of painful expressions.The study was registered at the Chinese Clinical Trial Registry(ChiCTR2200055571).Results Sixty neonates(experimental group,n=29;control group,n=31)were included in the final analysis.The maximum PIPP-R score in the experimental and control groups was 12.00(9.50,13.00),12.50(10.50,13.75),respectively(median difference−0.5,95%CI−2.0 to 0.5),and minimum rScO_(2)was(61.22±3.07)%,(61.32±2.79)%,respectively(mean difference−0.325,95%CI−1.382 to 0.732),without significant differences.During arterial puncture,the mean rScO_(2),HR,and SpO_(2)did not differ between groups.After needle withdrawal,the trends for rScO_(2),PIPP-R score,and facial expression returning to baseline were different between the two groups without statistical significance.Conclusion The white noise intervention did not show beneficial effects on pain-related cortical response as well as pain score,behavioral and physiological parameters in neonates with procedural pain.