The Effect of ShotBlocker and Vibration Pen on Pain During Vaccination in Healthy Infants: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- FLACC Scale
研究概览
简要总结
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.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infant aged 2-6 months
- •Written consent from the parent
排除标准
- •Premature infants born before 37 weeks
- •Infants with severe neurodevelopmental disorders
- •Presence of acute infection or fever
- •History of a previous serious vaccine reaction
研究组 & 干预措施
Experimental 1
ShotBlocker Group
干预措施: ShotBlocker Group (Other)
Experimental 2
Vibration device group
干预措施: Vibration Group (Other)
Control
Routine nursing care
结局指标
主要结局
FLACC Scale
时间窗: 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.
次要结局
未报告次要终点
研究者
Sümeyye EKİCİ
Research Assistant
Ataturk University