This study was conducted to investigate the effects of ShotBlocker and a vibration pen on pain in infants during routine vaccination. In this randomized controlled trial, 96 healthy infants aged 2-6 months were included. The infants were randomized into three groups: vibration pen, ShotBlocker, and control. Pain was assessed before, during, and after the procedure using the FLACC scale.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
96
ShotBlocker is a plastic medical device with multiple blunt projections that is applied by pressing on the skin during injection. It aims to reduce pain transmission through activation of the Gate Control Theory by stimulating multiple sensory nerve endings and diverting the infant's attention from the painful stimulus.
The vibration pen is a battery-operated device that delivers high-frequency mechanical vibrations and is applied near the injection site. It aims to reduce perceived pain intensity by stimulating large-diameter nerve fibers and inhibiting pain transmission at the "gate" level.
Ataturk University
Yakutiye, Erzurum, Turkey (Türkiye)
FLACC Scale
The FLACC score will be used as the data collection tool. The FLACC scale is a valid and reliable measure that assesses infant pain by evaluating five domains-facial expression, leg movement, activity level, crying, and consolability-and scores pain on a scale from 0 to 10.
Time frame: up to 6 months
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