The Effect of Heel Warming With Mild and Hot Thermofor Applied Before Heel Lance on Total Crying Time and Procedure Time in Healthy Term Newborns.: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Prosedüre time measure
研究概览
简要总结
Heel warming with thermophor during heel blood collection is a cost-effective and easy-to-apply method. In previous studies, it has been shown that applying heat to the heel reduces the pain of taking heel blood, increases comfort and shortens the procedure time and total crying time. Warm aplication increases the skin surface temperature, causing proximal vasodilation, thereby accelerating blood flow and increasing blood circulation. Increased blood circulation can reduce the pressure applied to the heel of newborns, shorten the procedure time, reduce the perception of pain and increase comfort. As a result of the literature review, it is seen that there is no clarity about the temperature degrees used in heel heating. It has been seen in the literature that warming the heel before heel blood collection is often carried out as mild (34-37C) or hot (38-40C). This study aims to determine heel warming with mild (34-37C) and hot (38-40C) thermofor applied before heel lance on total crying time and procedure time in healthy term newborns.
详细描述
Aim: The effect of heel warming with mild (34-37C) and hot (38-40C) thermofor applied before capillary heel blood sampling on total crying time and procedure time in term newborns.
Method: This study was planned as a randomized controlled, experimental, double-blind, single-center study. The universe of the research will be term newborns whose heel blood samples will be taken within the scope of the Newborn Screening Program (NSP) in the Isparta Şehir Hospital Gynecology and Obstetrics III Service.
The sample of the study was determined as 120 healthy term newborn (40 control, 40 intervention 1, 40 intervention 2).
Intervention: In this study, ineffective heel warming with thermofor will be applied to the control group; heel warming with mild (34-37C) thermofor will be applied to the intervention group 1; heel warming with hot (38-40C) thermofor will be applied to the intervention group 2. All newborns will breastfed from their mothers during and after the procedure.
Data collection instruments: Newborn Information Form (NIF).
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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 24 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born between 38-42 gestational weeks (term newborns)
- •Newborns with a birth weight of 2500-4400 grams
- •Newborns with stable physiological parameters and general condition
- •Newborns with vitamin K and hepatitis B vaccine in the delivery room
- •Newborns with eight or more Apgar scores in the first and fifth minutes
排除标准
- •Newborns with problems during pregnancy, labor and postpartum
- •Newborns with congenital anomaly
- •Newborns receiving pharmacological or non-pharmacological pain management intervention before the procedure
- •Newborns with receiving oxygen therapy
- •Newborns with having undergone a surgical procedure
- •Newborns with sepsis or suspected sepsis
- •Newborns whose parents state that they want to leave the study while the study continues
结局指标
主要结局
Prosedüre time measure
时间窗: During the procedure
The video recording will be monitored by independent evaluator who do not know the purpose of the study, and the processing time will be recorded.
次要结局
- Total crying time(Up to 5 minutes after the heel stick)