The Effect of a Foot Bath Before Capillary Heel Blood Sampling on Pain and Procedure Time in Neonates: 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
- 80
- 试验地点
- 2
- 主要终点
- Prosedüre time measure
研究概览
简要总结
Foot bath is a simple warm application method that creates a feeling of comfort and positive effects on health have been reported in the literature. There are studies reporting the benefits of footbath for different groups. However, no study has been found in the literature investigating the effect of foot bath for heel warming before heel stick procedure on pain, and procedure time. Foot bath to be applied during heel blood collection is a cost-effective and easy-to-apply method. This study aims to determine the effect of foot bath for heel warming before heel stick procedure on pain, and procedure time in healthy term newborns.
详细描述
Aim: This study aimed to determine the effect of foot baths applied before capillary heel blood sampling for newborn on pain level and procedure duration in term newborns.
Method: This study was planned as a randomized controlled, experimental, 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 size of the study was calculated based on the first hypothesis of the study with the G*Power 3.1 program. The sample of the study was determined as 80 healthy term newborn (40 control, 40 intervention).
Intervention: In this study, ineffective heel warming with thermofor will be applied to the control group and foot bath for heel warming will be applied to the intervention group.
Data collection instruments: Newborn Information Form (NIF), and NIPS (Neonatal Infant Pain Scale) will be used to collect data.
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 two independent evaluators who do not know the purpose of the study, and the processing time will be recorded.
次要结局
- NIPS (Neonatal Infant Pain Scale)(Pre-intervention/pre-evaluation (T1); during the procedure (T2); 1 minute after the procedure (T3); and 5 minutes after the procedure (T4).)