Effects of Fetal Positioning on Pain and Physiological Parameters During Venipuncture in Preterm Neonates: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
The study was aimed to examine the effects of fetal positioning during venipuncture on the neonates' pain score and physiological parameters (heart rate, blood-oxygen saturation, body temperature, crying duration) in neonatal intensive care unit (NICU).
This randomized controlled clinical trial was conducted between 10.2021-07.2022 with 60 preterm neonates, aged 26-32 week of gestation. Neonates were divided into intervention group (n=30) and control group (n=30) according to the randomization method. The neonates in the intervention group were put into fetal positioning at least 10 minutes before the procedure, and then venipuncture was performed. The fetal positioning was maintained throughout the procedure and the patient was kept in the fetal position for at least five more minutes after the procedure. Changes in the neonates' pain score and crying duration as well as heart rate, blood temperature, blood-oxygen saturation at three time points: before the procedure, immediately after needle insertion, five minutes after needle removal. Data was collected using the sociodemographic form, neonatal observation form and Neonatal Pain, Agitation and Sedation Scale (N-PASS). The collected data were analyzed using the SPSS 15 software.
The main questions it aims to answer:
- Does fetal positioning have an effect on pain score of premature neonates?
- Does fetal positioning have an effect on heart rate of preterm neonates?
- Does fetal positioning have an effect on oxygen saturation of preterm neonates?
- Does fetal positioning have an effect on body temperature of the preterm neonates?
- Does fetal positioning have an effect on the crying duration of preterm neonates?
详细描述
Neonates who were hypotonic, lethargic, in shock or had seizures, stage 3-4 intracranial hemorrhage and a history of surgery were not included in the study. Additionally, neonates was taken any analgesic and/or sedative in the last 24 hours were excluded from the study.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature newborns (a) whose parents volunteered to participate in the study, (b) required venipuncture, and (c) were born at 26-32 gestational weeks were included in the study.
排除标准
- •Newborns who are hypotonic, lethargic, in shock or having seizures,
- •Newborns with a history of stage 3-4 intracranial hemorrhage
- •Newborns with a history of surgery
- •Newborns whose gestational week is over 37 weeks
- •Newborns who have taken any analgesics and/or sedatives in the last 24 hours,
- •Newborns who have had any invasive procedure within the last hour
- •Newborns whose parents do not volunteer
结局指标
主要结局
Pain score
时间窗: Before the procedure, immediately after needle insertion, five minutes after needle removal.
Neonatal Pain Agitation and Sedation Scale (N-PASS) is a multidimensional scale that scores 5 behavioral and physiologic parameters for both pain and sedation. It is proficient in assessing continuous, acute, and chronic pain. In the scale crying/irritability, behavior state, facial expression, ekstremites tone and vital signs of newborns are scored between 0-2 points and the total score is obtained. A minimum of 0 and a maximum of 10 points are obtained from the scale, and an increase in score indicates an increase in pain. A score of four and below reflects mild pain, and a score of five and above reflects moderate and severe pain.
Oxygen saturation
时间窗: Before the procedure, immediately after needle insertion, five minutes after needle removal.
The neonates' oxygen saturation was monitored with a neonatal monitor and recorded on the monitoring form.
Heart rate
时间窗: Before the procedure, immediately after needle insertion, five minutes after needle removal.
The newborn's heart rate was monitored with a neonatal monitor and recorded on the monitoring form.
Body temperature
时间窗: Before the procedure, immediately after needle insertion, five minutes after needle removal.
The neonates' body temperature was monitored with a neonatal monitor and recorded on the monitoring form.
次要结局
- Crying duration(Before the procedure, immediately after needle insertion, five minutes after needle removal.)
研究者
Evrim Kızıler
Assistant Professor
Ankara Yildirim Beyazıt University