Background: Pain can cause deterioration in physiological, behavioural, and cognitive functioning. It is important to reduce perceived pain during painful procedures such as vaccination using pharmacological and non-pharmacological methods. Objectives: The study was carried out to compare the effectiveness of different non-pharmacological methods in pain management during vaccination. Methods: This randomised controlled study with placebo and control groups was conducted with 175 infants, who were randomly assigned to one of the ShotBlocker® (n = 35), ShotBlocker®-placebo (n = 35), sucrose (n = 35), sucrose-placebo (n = 35) or control (n = 35) groups. Pain levels of the infants were determined by assessors (nurses, parents, and observer) using the Neonatal Infant Pain Scale (NIPS) before and during vaccination. Results: There was no significant difference in infant age, weight, length, and gender among the five groups. There were statistically significant differences between the pain scores determined by the parents, nurses, and observer for the ShotBlocker®, sucrose, ShotBlocker®-placebo, sucrose-placebo, and control groups. The pain scores of infants in the ShotBlocker® and sucrose groups were statistically lower than those in the placebo and control groups (p < .001). Conclusion: It was concluded that the use of ShotBlocker® and sucrose reduced pain levels during vaccination according to all observers and that there was no statistically significant difference between these two methods. In order to minimize the perceived pain in infants during vaccination it is recommended that healthcare professionals (nurses and midwives) would use these methods in clinical practice.
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