Adiyaman University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Pain Scale
研究概览
简要总结
Aim: The study was aimed to identifying the effects of foot massage and acupressure on pain during heel lancing in neonates.
Methods: A single-blinded randomized controlled trial was performed in a university hospital in Turkey between April-December 2018. Neonates were randomized into three groups as acupressure, massage and control groups. Data were obtained by using Information form, Neonatal Infant Pain Scale (NIPS), pulse oximeter device and chronometer. Acupressure was applied to the neonates in the acupressure group and massage was given to the neonates in the massage group for 2 minutes before heel lancing procedure. Pain levels of the neonates in the groups were evaluated during and 1 minute after heel lancing procedure. Furthermore, the oxygen saturation and heart rate values of the neonates in the groups were measured by pulse oximeter device before, during and after heel lancing procedure. Duration of crying and heel lancing procedure were recorded by chronometer.
详细描述
Massage is a systematic and scientific procedure applied by using hands or special tools. As for acupressure, it is a method applied by stimulating the acupuncture points using hands and fingers by applying pressure on the meridians in body.Both methods are reliable, economic and easy to learn and apply. Review of the related literature indicates studies on the effectiveness of acupressure and foot massage on reducing pain in neonates.
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
- Single (Investigator)
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 2500-4000 gr body weight and being term neonates,
- •having APGAR score of over 7 five minutes after birth,
- •having no health problems detected in the newborn examination after birth,
- •having received no painful interventions apart from Hepatitis B and Kvit after birth,
- •being with the mother and being fed orally,
- •having had breast milk within 30 minutes before heel lancing
- •having a clean diaper.
排除标准
- 未提供
研究组 & 干预措施
acupressure group
2 neonates did not calm down before heel lancing; oxygen saturation and heart rate values of 2 neonates could not be monitored because the pulse oximeter tool probe was not fastened well.
Acupressure was performed when the mother was holding the neonate on her arm. For two minutes, acupressure was performed in the acupressure points (Kun Lun (UB60) and Taixi (K3). Each point was applied acupressure for 60 seconds, and heel lancing was performed right after this procedure. The acupuncture points that Kun Lun (UB60) and Taixi (K3) are on the side of the ankle.
干预措施: nonpharmalogocial methods (Other)
masssage group
oxygen saturation and heart rate values of 2 neonates could not be monitored because the pulse oximeter tool probe was not fastened well; heel lancing could not be performed at the first attempt (2 neonates).
Foot massage was performed when the mother was holding the neonate on her arm. Each neonate was given foot massage for two minutes, and heel lancing was performed right after the massage.
干预措施: nonpharmalogocial methods (Other)
control group
oxygen saturation and heart rate values of 1 neonates could not be monitored because the pulse oximeter tool probe was not fastened well; heel lancing could not be performed at the first attempt (2 neonates).
No application was made to theneonates in the control group before heel lancing procedure
结局指标
主要结局
Pain Scale
时间窗: 1 minute
Neonatal Infant Pain Scale (NIPS): The scale was developed by Lawrence et al. in 1993 in order to asses the behavioral and physiological pain responses of premature and term neonates. The scale consists of five behavioral and one physiological sections including facial expression, crying, breathing, arm and leg movements, and alertness. Total scores range between 0 and 7. Scores from 0 to 2 indicate mild to no pain, 3 to 4 indicates mild to moderate pain, and \>4 indicates severe pain. Higher scores indicate more severe pain. In the study of Lawrence et al., NIPS 's Cronbach's Alpha 0.92 found (Larwence et al. 1993). The scale was adapted to Turkish by Akdovan, NIPS is used for the assessment of procedural pain of the premature and term neonates. Akdovan found the Cronbach's Alpha value to be 0.83. The pain intensity of neonates was evaluated during and 1 minute after heel lancing procedure
次要结局
未报告次要终点
研究者
Tuba Koc Ozkan
Adiyaman University School of Health
Adiyaman University Research Hospital