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Clinical Trials/NCT06246266
NCT06246266
Not yet recruiting
Not Applicable

Effectiveness of Helfer Skin Tap Technique and ShotBlocker Technique in Reducing Pain in Babies Receiving Intramuscular Vaccination

Ondokuz Mayıs University0 sites60 target enrollmentFebruary 5, 2024
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Ondokuz Mayıs University
Enrollment
60
Primary Endpoint
Neonatal Infant Pain Scale = NIPS
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to examine the effectiveness of the Helfer Skin Tap Technique and the ShotBlocker Technique in reducing pain in babies receiving intramuscular vaccination.

Detailed Description

During immunization, babies feel pain from the injection and give behavioral reactions such as crying and struggling in response to this pain. Pain-reducing methods (Buzzy device, cold application, hot application, music, virtual reality, distracting cards, stress ball, etc.) are used during intramuscular vaccine injection in children. Studies using the Helfer Skin Tap Technique and ShotBlocker Technique, which are easy to apply and proven effective in reducing pain in infancy vaccination applications, are limited. Therefore, this study aims to examine the effectiveness of the Helfer Skin Tap Technique and the ShotBlocker Technique in reducing pain in babies receiving intramuscular vaccination.

Registry
clinicaltrials.gov
Start Date
February 5, 2024
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ondokuz Mayıs University
Responsible Party
Principal Investigator
Principal Investigator

Esra TURAL BUYUK

Associate Professor

Ondokuz Mayıs University

Eligibility Criteria

Inclusion Criteria

  • Born between 38 and 42 weeks of gestation,
  • Between 2 and 4 months old,
  • Applying to the family health center for KPA (Conjugated Pneumococcal Vaccine) application,
  • No congenital anomalies, birth asphyxia or any chronic disease

Exclusion Criteria

  • Born prematurely or postmaturely
  • Not between 2 and 4 months old
  • Those who come to the family health center for the administration of other vaccines other than the KPA (Conjugated Pneumococcal Vaccine) application administered via IM route.
  • Those with congenital anomalies, birth asphyxia or any chronic disease

Outcomes

Primary Outcomes

Neonatal Infant Pain Scale = NIPS

Time Frame: Immediately after vaccination, the baby's pain will be evaluated with the Newborn Infant Pain Scale (NIPS).

The Newborn-Infant Pain Scale, developed by Lawrence et al. (1993) to evaluate the physiological and behavioral responses of newborns to pain, was adapted into Turkish by Akdovan (1999). Scale; It consists of five behavioral and one physiological parts, including facial expression, crying, breathing pattern, arm and leg movements, and sleep-wake state. The crying part of the scale is given 0-1 and 2 points, and the other parts are given 0-1 point. The total score can range from 0 to 7, and a score higher than 3 indicates greater pain intensity.

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