Zeynep Kamil Maternity and Children's Research and Training Hospital, Department of Neonatal Intensive Care, Istanbul, Türkiye.
Istanbul Medeniyet University, Department of Pediatric Nursing, Faculty of Health Sciences, Istanbul, Türkiye.
J Pediatr Nurs. 2024 Nov-Dec;79:e51-e59. doi: 10.1016/j.pedn.2024.09.019. Epub 2024 Oct 11.
This study aimed to examine the effect of mechanical vibration and the ShotBlocker® device on pain level, crying time, and procedure time during a heel lance in healthy term neonates.
A total of 105 healthy-term neonates were randomized into three groups: control (n = 36), mechanical vibration (n = 33), and ShotBlocker® (n = 36). The control group underwent a routine heel lance procedure. The neonates in the mechanical vibration group received mechanical vibration to the extremity for 30 s before the heel was lanced. For the ShotBlocker® group, a ShotBlocker® was placed on the area where the heel lance procedure would occur and the heel was lanced. The heel lance procedure was videotaped, and the neonates' pain scores at 1 min before, 2 min after, and 5 min after the procedure, crying time, and procedure duration were recorded and were evaluated by two independent raters. Data were evaluated using the chi-square test and analysis of variance. The analysis of variance, Bonferroni, Dunnett T3 analysis, and effect size were used in the analyses of repeated measures. The study was approved by an ethics committee. Informed consent was obtained from parents.
The pain level of the neonates in the mechanical vibration group was lower than those of the control and ShotBlocker® group during and at 2 min and 5 min after the procedure (F = 12.063, p = 0.000; F = 4.580, p = 0.012; and F = 6.145, p = 0.003, respectively). The duration of neonate crying time in the mechanical vibration group was lower than in the control and ShotBlocker® groups (F = 4.598, p = 0.012). The heel lance duration was similar in the groups (F = 1.369, p = 0.259).
Mechanical vibration is an effective method to reduce the pain level and crying time associated with heel lance procedures in neonates.
This study provides evidence to nurses that the ShotBlocker is not an effective method for reducing pain associated with the heel lance procedure but that mechanical vibration is an effective method.
The study was registered at Clinical-Trials.gov (NCT06380556).
本研究旨在探讨机械振动和 ShotBlocker® 装置对健康足月新生儿足跟穿刺过程中疼痛水平、哭泣时间和操作时间的影响。
将 105 例健康足月新生儿随机分为三组：对照组（n=36）、机械振动组（n=33）和 ShotBlocker® 组（n=36）。对照组行常规足跟穿刺术。机械振动组在足跟穿刺前对肢体进行 30 秒机械振动。ShotBlocker® 组在将要进行足跟穿刺的部位放置 ShotBlocker®，然后进行足跟穿刺。足跟穿刺过程被录像，由两名独立的评估者记录新生儿在操作前 1 分钟、操作后 2 分钟和 5 分钟的疼痛评分、哭泣时间和操作持续时间，并进行评估。数据采用卡方检验和方差分析进行评估。重复测量采用方差分析、Bonferroni、Dunnett T3 分析和效应量进行分析。该研究得到伦理委员会的批准。家长签署了知情同意书。
机械振动组新生儿在操作过程中和操作后 2 分钟和 5 分钟时的疼痛水平低于对照组和 ShotBlocker® 组（F=12.063，p=0.000；F=4.580，p=0.012；F=6.145，p=0.003）。机械振动组新生儿哭泣时间的持续时间短于对照组和 ShotBlocker® 组（F=4.598，p=0.012）。三组足跟穿刺时间无差异（F=1.369，p=0.259）。
机械振动是一种有效降低足跟穿刺术引起的疼痛水平和哭泣时间的方法。
本研究为护士提供了证据，表明 ShotBlocker 不是一种有效降低足跟穿刺术相关疼痛的方法，但机械振动是一种有效的方法。
该研究在 Clinical-Trials.gov 上注册（NCT06380556）。
