Nonpharmacologic strategies exist to manage procedural pain in healthy newborn infants. The aim of this prospective randomized controlled trial (RCT) was to examine the efficacy of ShotBlocker for managing injection pain associated with the first intramuscular hepatitis B vaccine given to healthy full-term neonates. This randomized controlled trial study was conducted in a private university hospital in Istanbul, Turkey, in which 100 healthy term neonates were randomly assigned to either a ShotBlocker (n = 50) or control group (n = 50). The Neonatal Infant Pain Scale scores of the neonates in the ShotBlocker and control groups were compared before, during, and after the injections, and the physiological parameters were compared before and after the procedure. The pain scores of the neonates during (ShotBlocker group: 1.64 ± 0.80; control group: 2.96 ± 0.73) and after (ShotBlocker group: 0.74 ± 0.66; control group: 1.42 ± 0.76) the injection procedure were lower in the ShotBlocker group than in the control group (P = .000). The postinjection heart rate in the infants in the ShotBlocker group (145.02 ± 13.50) was found to be lower than in those for whom ShotBlocker was not used (150.24 ± 13.36) (P = .05). The use of ShotBlocker during the hepatitis B vaccine in term neonates is effective in reducing the acute pain.