The Effect of Facilitated Tucking, Maternal Breast Milk Odor and Non Nutritive Sucking During Heel Stick on Procedural Pain in Premature Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
研究概览
简要总结
Aims and objectives: This study was performed to examine the effects of Non-nutritive sucking, breast milk odor, and Facilitated tucking on preterm infant pain before, during, and after heel-stick procedures.
Design: A randomized clinical trial in a single center.
Methods:
The study was conducted on 144 premature infants with a gestational age of 31 to 36 weeks and 6 days hospitalized in the neonatal intensive care unit of Shahid Sayad Shirazi Hospital in Iran. Neonates were randomly assigned to four groups: 36 babies were included in the Non-nutritive sucking(1st Group), 36 in breast milk odor (2nd Group), 36 in Facilitated tucking (3rd Group), and 36 in the control group (4th Group). Pain score, heart rate, oxygen saturation, and respiratory rate of the babies in all groups before, during, and after the procedure were evaluated by two nurses independently.
详细描述
Aim: Due to the necessity of various painful procedures and their side effects on infants, pharmacological and non-pharmacological methods are adopted to reduce the pain. Since pharmacological methods can be associated with several side effects, it is better to use non-pharmacological methods for pain control in newborns. Therefore, the purposes of this study were to compare the effects of three different methods (including Non-nutritive sucking, breast milk odor, and Facilitated tucking) on preterm infant pain before, during, and after heel-stick procedures.
Method: The study was conducted on 144 premature infants with a gestational age of 31 to 36 weeks and 6 days hospitalized in the neonatal intensive care unit of Shahid Sayad Shirazi Hospital, Iran. Initially, neonates are divided into two groups according to gestational age (including neonates between 31-33 weeks and 34-36 weeks) to moderate the confounding effect of the age, and then the allocation of neonates to four groups was performed.
Using the stratification block randomization method, 36 babies were included in the Non-nutritive sucking(1st Group), 36 in breast milk odor (2nd Group), 36 in Facilitated tucking (3rd Group), and 36 in the control group (4th Group). Two researchers viewed the recorded videos independently and evaluate the heart rate, oxygen saturation, respiratory rate, and neonatal pain at 1st,2nd,3rd minute before the procedure, during, and at 1st,2nd,3rd minutes after the procedure according to the Premature Infant Pain Profile (PIPP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Day 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Week of gestation is between 31 and 36 weeks
- •Not being exposed to a painful procedure at least 1 hour before the interventions
- •At least 1 hour has passed since feeding
- •Not taking analgesics and/or sedatives in the last 4 hours
- •Body weight of 1000 grams or more
- •Having mother's milk
- •Not exceeding the 10th day of postnatal age
排除标准
- •Having ventilator support
- •Having a congenital anomaly
- •Using analgesic / narcotic analgesic drugs
- •Continuous sedative treatment
- •Having a congenital malformation that may cause asphyxia and affect respiration
- •Having intracranial bleeding
结局指标
主要结局
Pain score of preterm infants assessed on the Premature Infant Pain Profile Revised (PIPP-R)
时间窗: Pain was measured at 3 minutes after the procedure by two researchers independently.
PIPP is a valid instrument that can be used to assess infants' response to pain. The instrument estimates the baby's pain based on assigning a score of zero to four to each of the fetal ages, behavioral status, maximum heart rate, minimum oxygen saturation, eyebrow bulges, eye presses, lip and nose creases. This tool's minimum and maximum pain scores are zero and 21, respectively.
次要结局
- Oxygen saturation(From 4 minutes before heel stick to 4 minute after heel stick)
- Heart rate during heel stick(from 4 minutes before heel stick to 4 minute after heel stick)
- Respiratory rate(From 4 minutes before heel stick to 4 minute after heel stick)
研究者
Negarin Akbari
Principal Investigator
Istanbul University - Cerrahpasa (IUC)