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The Effect of ShotBlocker and Vibration on Pain During Vaccination

A

Ataturk University

Status

Completed

Conditions

Shotblocker
Vibration
Vaccination
Infant
Pain

Treatments

Other: Vibration Group
Other: ShotBlocker Group

Study type

Interventional

Funder types

Other

Identifiers

NCT07379034
Research1

Details and patient eligibility

About

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.

Enrollment

96 patients

Sex

All

Ages

2 to 6 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

96 participants in 3 patient groups

Experimental 1
Experimental group
Description:
ShotBlocker Group
Treatment:
Other: ShotBlocker Group
Experimental 2
Experimental group
Description:
Vibration device group
Treatment:
Other: Vibration Group
Control
No Intervention group
Description:
Routine nursing care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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