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临床试验/NCT06246266
NCT06246266尚未招募不适用

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

Ondokuz Mayıs University0 个研究点目标入组 60 人开始时间: 2024年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Neonatal Infant Pain Scale = NIPS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
2 Months 至 4 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Neonatal Infant Pain Scale = NIPS

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra TURAL BUYUK

Associate Professor

Ondokuz Mayıs University

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