The Effect of ShotBlocker and Vibration on Pain During Vaccination

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.

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Key information

Conditions

Vaccination Infant Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shotblocker Signs and Symptoms Vibration

Age range

2 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Yakutiye, Erzurum, 25240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy infant aged 2-6 months
Written consent from the parent

Exclusion criteria

Premature infants born before 37 weeks
Infants with severe neurodevelopmental disorders
Presence of acute infection or fever
History of a previous serious vaccine reaction

Treatment and study plan

ShotBlocker Group

Other

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.

vibration group

Other

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.

Primary outcomes

FLACC Scale

Time frame: up to 6 months

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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 30, 2026
Registry last updated: Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed