Effects of Using Various Heel-warming Methods Such As Warm Towel Warming and a Thermophore Heating Pad Warming Before Heel Prick on Newborns' Pain Level and Duration of Crying
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Neonatal Infant Pain Scale (NIPS)
研究概览
简要总结
In the present study, the randomized controlled and experimental design is used because it was aimed to determine the effects of two different warming methods (warming with a thermophore heating pad and warming with a warm towel) performed before heel prick intervention on pain levels and duration of crying in healthy term newborns.
Study hypotheses are; Hypothesis 1. Using the thermophore pad warming method in newborns before heel prick reduces the newborn's pain level.
Hypothesis 2. Using the warm towel warming method in newborns before heel prick reduces the newborn's pain level.
Hypothesis 3. Using the thermophore pad warming method in newborns before heel prick reduces the duration of crying.
Hypothesis 4. Using the warm towel warming method in newborns before heel prick reduces the duration of crying
详细描述
Heel prick, intervention performed to take blood sample from the heel, which is frequently performed in newborns, is a more painful intervention than are other methods of taking blood samples. In several studies, it has been indicated that the use of various non-pharmacological methods such as sucrose administration, breastfeeding, skin-to-skin care, acupressure, swaddling, positioning, non-nutritive sucking, foot reflexology, vibration, laser acupuncture, warming the baby's heel reduce infants' pain during heel prick.
This study is a prospective, randomized and controlled trial. In this study aim, was aimed at determining the effects of two different heel warming methods (warming with a thermophore heating pad and warming with a warm towel) performed before heel prick on healthy term newborns' pain levels and duration of cryingin newborns will be examined.
The minimum number of newborns to be included in the study was calculated as 150 using the G*Power (3.1. 9.7) program (margin of error: 5%, confidence interval: 0.95, power: 0.80). The 150 newborns in the sample were randomly assigned into the following three groups in equal numbers via an internet-based program (http://www.randomizer.org): control group (n = 50), thermophore-warming group (n = 47) and warm towel-warming group (n = 50).
Data Collection Tools To collect the study data, the "Descriptive Information Form", "Follow-up Form", and "Neonatal Infant Pain Scale" were used.
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
- None
入排标准
- 年龄范围
- 1 Day 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having been born at 38-42 weeks of gestation,
- •having a birth weight of 2500 g and above,
- •having a 5-min APGAR score of 7 and above,
- •having stable health,
- •having been fed within an hour before the intervention, being calm and not crying before the intervention,
- •having a postnatal age of 24-72 hours, and
- •undergoing heel prick for the first time
排除标准
- •Parents with any mental problems
- •Infants with any chronic disease and congenital anomalies.
研究组 & 干预措施
Thermophore pad warming group
In the literature, (Lehmann, 1990; Shu et al., 2014), it is recommended that the heel should be warmed at a temperature ranging between 40°C and 45°C to increase blood flow before the heel prick test was performed. During the intervention, the newborn was wrapped with its own blanket leaving the extremity to be treated uncovered. Then, the thermophore heating pad filled with 40°C water was used to warm the sole of the foot for approximately 5 minutes just before the intervention. Attention was paid to prevent the thermophore heating pad from touching other parts of the baby's skin.
干预措施: Thermophore pad warming group (Procedure)
Warm towel warming group
In this group, to warm the heel, the heel area where the blood would be taken was wrapped with a previously heated towel before heel prick. A clean cotton towel was used to warm the newborns' heels. Before the intervention, to warm the towel, it was wrapped in a thermophore pad filled with water at a temperature of approximately 40°C-45°C. The foot area and the heel of the newborn where the blood would be taken were wrapped with a warm towel for 3-4 minutes before heel prick was performed.
干预措施: Warm towel warming group (Procedure)
Control group
In the newborns in this group, heel prick intervention was performed in line with the routine interventions of the clinic. The baby was wrapped in a blanket leaving the foot from which the blood sample would be taken unwrapped.
干预措施: Control group (Other)
结局指标
主要结局
Neonatal Infant Pain Scale (NIPS)
时间窗: Pain levels of the newborns evaluated during the procedures
Neonatal Infant Pain Scale: NIPS was developed by Lawrence et al. (1993)21 to evaluate behavioral and physiologic pain responses of preterm and term infants. The scale was adapted to Turkish by Akdovan (1999)22. In the present study, NIPS was used to evaluate the interventional (procedural) pain level of newborns. The scale consists of five behavioral (facial expressions, crying, wakefulness, arm and leg movements) and a physiologic (breathing) signs; 0-2 points are given to the crying indicator, 0-1 points are given to other indicators, and the total score is between 0 and 7. High scores indicate that the severity of pain is excessive.
次要结局
- Total criying time(The time of the procedure was measured from the beginning to the end of the heel stick procedure.)
研究者
Diler Yilmaz
Professor
Bandırma Onyedi Eylül University