The Effect of Warming and Vibration Applications on Pain During Heel Blood Collection in Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Change in level of pain
研究概览
简要总结
This study aimed to determine the effects of warming and vibration applications on pain during heel blood collection in newborns.
H1: Warming application has a positive effect on pain during heel blood collection in newborns.
H2: Vibration application has a positive effect on pain during heel blood collection in newborns.
H3: The combined application of warming and vibration during heel blood collection in newborns has a positive effect on pain.
详细描述
Heel blood collection is frequently used for neonatal metabolic screening and analysis of bilirubin, glucose and other biochemical/hematologic parameters. This process is both painful and stressful for the newborn. Pain experience in the neonatal period can cause intense stress in the infant and cause physiopathological changes such as respiratory irregularity, impaired thermoregulation, changes in heart rhythm, changes in oxygen saturation and blood pressure. Therefore, it is recommended to use evidence-based non-pharmacological methods to reduce the pain experiences of newborns and to minimize the short and long-term negative effects of pain.
Based on this rationale, this study was planned to evaluate the effect of non-pharmacologic methods on pain and procedure time together.
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
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborns
排除标准
- •Newborns with any lower extremity anomalies
- •Newborns with congenital diseases
研究组 & 干预措施
Control group
Newborns who will be subjected to routine practices during heel blood collection procedure and who will not be subjected to warming and vibration will constitute the control group.
干预措施: Control group (Other)
Experimental group (warming)
Newborns who will be subjected to warming application during the heel blood collection procedure will constitute the 1st experimental group.
干预措施: Warming (Other)
Experimental group (vibration)
Newborns who will be subjected to vibration during the heel blood collection procedure will constitute the 2nd experimental group.
干预措施: Vibration (Other)
Experimental group (warming and vibration)
Newborns who will be subjected to both warming and vibration during the heel blood collection procedure will constitute the 3rd experimental group.
干预措施: Warming and vibration (Other)
结局指标
主要结局
Change in level of pain
时间窗: Immediately before the prosedure, during the procedure, immediately after the procedure. The change in these time period will be measured.
The level of pain will be measured using the N-PASS: Neonatal Pain/Agitation, Sedation Scale. The scale was developed by Hummel, Lawlor-Klean and Weiss in 2010, its Turkish validity and reliability were made by Açıkgöz et al. in 2017. N-PASS consists of two sections: sedation and pain assessment. Total pain score varies between 0 and +11 and total sedation score varies between 0 and +10. A high score indicates severe pain. The aim is to keep the score at 3 and below. If it is above 3 points, sedation requirements are evaluated. The average time spent to administer the scale is 1 minute.
次要结局
未报告次要终点
研究者
Zehra Kan Onturk
Assoc. Prof.
Acibadem University