NCT07379034

The Effect of ShotBlocker and Vibration on Pain During Vaccination

The Effect of ShotBlocker and Vibration Pen on Pain During Vaccination in Healthy Infants: A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Ataturk University · Academic / Other
• Sex: All
• Age: 2 Months – 6 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Vaccination
• Pain
• Infant
• Shotblocker
• Vibration

Interventions

Type	Name	Description
OTHER	ShotBlocker Group	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.
OTHER	Vibration Group	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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-01-23
• Completion: 2026-01-23
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

1 site across 1 country: Turkey (Türkiye)