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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07379034

Enrollment

Registered

2026-01-30

Start date

2025-10-01

Completion date

2026-01-23

Last updated

2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Pain, Shotblocker, Vaccination, Vibration

Keywords

vaccination, pain, infant, Shotblocker, Vibration

Brief 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.

Interventions

OTHERShotBlocker 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.

OTHERVibration 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Months to 6 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
FLACC Scale	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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026