The Effect of Buzzy® Application on the Pain Level During Vaccine Injection in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The effect of Buzzy® administered during vaccine injection on the infant's pain level during vaccine injection.
研究概览
简要总结
The research was conducted as a randomized controlled experiment to investigate the effect of Buzzy® on pain level during the measles-rubella-mumps (MMR) vaccine injection in 12-month-old infants. This study was done with infants meeting the sampling criteria (buzzy group: 30, control group: 30) on November 2018-May 2019 in Istanbul Bakirkoy 9 Family Health Center.
详细描述
To determine the effect of Buzzy® application on pain, which is a combination of cold and vibration, during measles-rubella-mumps (MMR) vaccine injection administration on 12-month-old infants. The study is a randomized contrlled experimental research. The research sample is composed of 60 infants (buzzy:30, control:30) who are 12-month-old injected MMR vaccine at Bakırköy No. 9 Family Health Center between November 2018-May 2019. As a data collection tool Data Collection Form, FLACC Pain Scale and Buzzy® device have been used. While Buzzy® was applied on infants in the trial group before, during and after the vaccine injection, the infants in the control group were applied routine vaccine injection. The pain response of the infants was evaluated by the nurse and the parent before, during and after the vaccine injection and the physiological parameters were evaluated by the nurse before and after the vaccine injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The baby has completed 12 months,
- •MMR vaccine will be applied,
- •Being at a suitable weight for the month,
- •The baby has not been given analgesic medication during the day,
- •It can be listed as the parent's willingness to participate in the research.
排除标准
- •It can be listed as having a body temperature above 37.5.
结局指标
主要结局
The effect of Buzzy® administered during vaccine injection on the infant's pain level during vaccine injection.
时间窗: 30 seconds
FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
The effect of Buzzy® administered during vaccine injection on infant blood pressure before vaccine injection.
时间窗: 30 seconds
blood pressure
The effect of Buzzy® administered during vaccine injection on infant blood pressure after vaccine injection.
时间窗: 30 seconds
blood pressure
The effect of Buzzy® administered during vaccine injection on the infant's SpO2 after vaccine injection.
时间窗: 30 seconds
SpO2
The effect of Buzzy® administered during vaccine injection on the infant's pain level before vaccine injection.
时间窗: 30 seconds
FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
The effect of Buzzy® administered during vaccine injection on the infant's pulse after vaccine injection.
时间窗: 30 seconds
pulse rate
The effect of Buzzy® administered during vaccine injection on the infant's pain level after vaccine injection.
时间窗: 30 seconds
FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
The effect of Buzzy® administered during vaccine injection on the infant's pulse before vaccine injection.
时间窗: 30 seconds
pulse rate
The effect of Buzzy® administered during vaccine injection on the infant's SpO2 before vaccine injection.
时间窗: 30 seconds
SpO2
次要结局
未报告次要终点
研究者
Ozge Siktas
Principal Investigator, RN, MSc
Okan University