The Effect of Vibration on Pain During Heel Lance Procedures in Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- G Power software was used to calculate the sample size of the study.
研究概览
简要总结
This study aimed to evaluate the effect of applying vibration on pain during heel lance procedures in newborns.
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详细描述
Methods: This randomized, controlled, experimental study. The study sample consisted of 56 newborns determined using power analysis (vibration: 28, control:28). Newborns who underwent a heel lance procedure at the specified center, whose parents agreed to participate in the study and who had reached gestational age 38 and older were enrolled in the study. In the vibration group, a vibrating device was used for approximately 30 seconds before the heel lance procedure and continued throughout the procedure. No interventions were made on the newborns in the control group. Two nurses were employed for the heel lance procedure both for the experimental and control groups. One nurse performed the heel lance procedure for all newborns and the other nurse recorded the procedure. Pain in newborns was evaluated by the nurse who performed the heel lance procedure before the procedure, and 15-20 seconds and five minutes after the procedure, as well as by two specialists through observation of the video footage of the procedures using the NIPS. The heel lance procedure was performed by the same nurse both in the vibration and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 30 Days(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age 38 and older
排除标准
- •Disrupted skin integrity in the device placement site, nerve damage or -deformity of the limb from which the blood would be collected,
- •Genetic and congenital anomalies
- •Congenital metabolic disorders,
- •those who had undergone cardiopulmonary resuscitation,
- •Stayed in the neonatal intensive care unit for any reason,
- •Heel blood could not be collected at the first attempt,
- •Osteogenesis imperfecta
- •Had been given an analgesic within the preceding 6 hours
结局指标
主要结局
G Power software was used to calculate the sample size of the study.
时间窗: 5 days
G Power
次要结局
未报告次要终点
研究者
Elif BİLSİN KOCAMAZ
Assistant Professor
University of Gaziantep
