Comparing the Analgesic Effects of Four Non-pharmacological Interventions on Term Newborns Undergoing Heel Lance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 主要终点
- Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions
研究概览
简要总结
The purpose of this study is to compare the analgesic effects of four non-pharmacological interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in newborns receiving a heel lance procedure.
详细描述
This is an randomized control clinical study. study population is healthy term newborns.Patients were identified by chart review and consent was received by nurse researcher. Newborns were randomized into either the control group who received no pain intervention or the intervention group who received one of four non-pharmacological pain interventions: skin to skin contact, breastfeeding, oral sucrose, and nonnutritive sucking.
A heel lance for newborn screen blood sampling was selected as a study procedure and performed by a hospital technician following standard protocol. Pain scoring was assessed by two research nurses after the hell lance and through the procedure. Neonatal Pain, Agitation and Sedation Scale (NPASS) was selected as a pain assessment tool for this study.
The average pain score from two research nurses were used for statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Hours 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational Age 38-40
- •2.5-4.0kg
- •24-48hours of age
- •Receiving heel lance procedure
- •Apgar>7 at birth
- •NPASS<3 at time of heel lance
排除标准
- •Prior heel lance procedure
- •birth trauma
- •forceps or vacuum delivery
- •maternal drug abuse during delivery
研究组 & 干预措施
Control
Newborns received no pain interventions during the procedure
Breastfeeding
Newborns were breastfed during the procedure
干预措施: breastfeeding (Behavioral)
Oral Sucrose
Newborns were given oral sucrose during the procedure
干预措施: oral sucrose (Dietary Supplement)
Skin to skin contact
Newborns were placed in direct contact with their mothers during the procedure
干预措施: Skin-to-Skin contact (Behavioral)
Non-nutritive sucking
Newborns were given a pacifier to suck on during the procedure
干预措施: Non-nutritive sucking (Behavioral)
结局指标
主要结局
Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions
时间窗: 12 month
Neonatal Pain, Agitation and Sedation Scale (NPASS) measures both behavioral and physiological components of pain by evaluating five key elements, and scores pain from 0-10 (Patricia A. Hummel, 2004). The assessment criteria are crying irritability, behavior state, facial expression, extremities tone, and vital signs.
次要结局
未报告次要终点
研究者
Annette Nasr
Clinical Assistant Professor, Pediatrics
Stanford University