Randomised Controlled Study: The Effects on Pain of Foot Reflexology and Acupressure During Heel Lancing In Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Pain levels of the newborns
研究概览
简要总结
This study aimed to determine the effects of foot reflexology and acupressure on the KI3 and St36 points on pain during interventions when these procedures were administered before heel lancing in term newborns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 24 Hours 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being born by cesarean section,
- •Being a term newborn,
- •Being completed the 24th hour of the postnatal period,
- •Staying with birth mother,
- •Being fed in the last half hour before the procedure,
- •Having a heel prick performed by the same nurse,
- •Giving blood on the first try (because pain level may change on the second try),
- •Having a mother who gave written informed consent
排除标准
- •Having no health problem,
- •Being underwent more than 2 invasive interventions,
- •Receiving an analgesic/sedative drug in the 8 hours before the application.
结局指标
主要结局
Pain levels of the newborns
时间窗: Before the pain procedure, during the pain procedure (the pain levels of the infants when the needle pricked the heel were evaluated using the N-PASS) and After the pain procedure. (Having completed the 24th hour of the postnatal period)
The N-PASS was developed by Hummel et al. in 2003 to be used in all full-term and preterm neonates. The scale was revised by Hummel on October 2, 2009 and adapted to Turkish by Açıkgöz et al. in 2011 The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.779 for preintervention and 0.917 for postintervention (Açıkgöz et al., 2017). The N-PASS consists of five sub-dimensions: crying and irritability, behavior-state, facial expression, extremities tone, and vital signs. The sub-dimension of vital signs was evaluated according to infants' heart rates and oxygen saturation values. The total pain score that can be obtained from the scale ranges between 0 and +10. A higher score indicates that the severity of pain is high. The goal of pain therapy is to keep the score at or below 3 (Hummel et al., 2008; Hummel et al., 2010).
次要结局
- Changes in heart rates(2 Minutes)
- Percentage of crying during heel prick in healthy term neonates(During heel prick and immediately after intervention)
- Changes in oxygen saturation(2 Minutes)
研究者
Ayşe Özge DENİZ
Principal Investigator
Eskisehir Osmangazi University