Effect of mechanical vibration and ShotBlocker® on pain levels during heel lance in healthy term neonates: A randomized controlled trial

Abstract

Purpose: This study aimed to examine the effect of mechanical vibration and the ShotBlocker (R) device on pain level, crying time, and procedure time during a heel lance in healthy term neonates. Design and methods: A total of 105 healthy-term neonates were randomized into three groups: control (n = 36), mechanical vibration (n = 33), and ShotBlocker (R) (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 (R) group, a ShotBlocker (R) 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 chisquare 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. Results: The pain level of the neonates in the mechanical vibration group was lower than those of the control and ShotBlocker (R) 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 (R) groups (F = 4.598, p = 0.012). The heel lance duration was similar in the groups (F = 1.369, p = 0.259). Conclusion: Mechanical vibration is an effective method to reduce the pain level and crying time associated with heel lance procedures in neonates. Practice implications: 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. Clinical trials registration: The study was registered at Clinical-Trials.gov (NCT06380556). (c) 2024 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.