The Effect of ShotBlocker and Vibration on Pain During Vaccination

NCT07379034 | Completed

• 1 other identifier: Research1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccination; Pain; Infant; Shotblocker; Vibration

Keywords

vaccination; pain; infant; Shotblocker; Vibration

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 6 months

Study Arms (3)

Experimental 1

EXPERIMENTAL

ShotBlocker Group

Other: ShotBlocker Group

Experimental 2

EXPERIMENTAL

Vibration device group

Other: Vibration Group

Control

NO INTERVENTION

Routine nursing care

Interventions

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.

Experimental 1

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.

Experimental 2

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Yakutiye, Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: October 1, 2025
• Primary Completion: January 23, 2026
• Study Completion: January 23, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)