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临床试验/NCT06077409
NCT06077409已完成不适用

''The Effect of Skin-to-Skin Contact and Gentle Touch Method Applied During Blood Collection on Early Detection of Pain and Physiological Parameters''

Istanbul University - Cerrahpasa (IUC)2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Preterm Pain

研究概览

简要总结

  1. babies under the gestational week are considered preterm babies, and babies between 32-37 gestational weeks are considered late preterm babies (WHO, 2023). Dec. While the preterm birth rate in the world is 10%, this rate is 13% in Turkey. The life rate of preterm babies has increased in recent years and they are subjected to many painful interventions for diagnosis, treatment and preventive purposes. At the time of birth, they experience painful interventions such as vitamin K, hepatitis B vaccine administration, heel blood collection. Painful interventions cause an increase in cortisol levels, resulting in impaired blood sugar in infants, impaired brain development, impaired growth and development (Akyildiz et al., 2023). In the short term, they may give signs of a decrease in oxygen saturation, an increase in heart rate, metabolic acidosis( Akcan et al., 2017). Procedural pain management is also important for the neurological development of preterm infants (Perg et al., 2018). For these reasons, the pain of the newborn due to interventional procedures should be managed well.

详细描述

Newborns are often exposed to acute or chronic pain due to different invasive interventions (Akcan and Polat, 2017). The American Pain Society (APS) accepts pain as the fifth physiological parameter (McCharty et al., 2013). The American Academy of Pediatrics (AAP) recommends minimizing pain due to invasive procedures (Aydın et al., 2016). Reducing pain first requires accurate assessment of pain and treatment with pharmacological/non-pharmacological interventions (Hussein, 2015). Pharmacological methods have risks such as drug-related side effects. For this reason, non-pharmacological methods are primarily preferred in acute pain (Hashemi et al., 2016).

Non-pharmacological methods for pain management are diverse. In recent years, non-pharmacological methods such as distraction, wrapping, positioning, aromatherapy, music, games, massage, kangaroo care, and oral sucrose have been used together or separately to reduce pain and/or stress-related behaviors (Abdallah et al., 2013).

In another application, the tent-to-skin contact method, the newborn is laid face down on the parent's chest. The newborn's back is covered to prevent heat loss. It is thought that this situation will relax the newborn and therefore perceive the pain as milder (Mayfield, 2019).

Gentle Human Touch is one of the therapeutic touch methods. Gentle touch, which is a simple and applicable method in newborns, is a non-invasive touch technique that does not require special equipment and technology. The gentle touch method is a sensitive tactile stimulation applied to the skin, without caressing or massage, and provides a relaxing effect on the baby (Dur et al., 2020; Fatohallazade, 2020).

Newborns need their parents, especially their mothers, to be with them during all kinds of interventions. For this reason, the parent should be with the newborn during the invasive interventions and take a primary role in the non-pharmacological interventions; It provides optimum comfort for the nurse, newborn and caregiver. It is important to benefit from the family-centered care model when using non-pharmacological methods. Family-centered care is a care model based on collaboration between health professionals and children's families in the planning, delivery and evaluation of health services. Its general goal is to increase the quality of health services for children and families, increase the satisfaction of families and health professionals, and ensure the effective use of personnel (Yılmaz and Gözen, 2019).

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
None

入排标准

年龄范围
32 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Mothers who volunteer to participate in the research,
  • Between 32-37 weeks of gestation,
  • No analgesics are given until 6 hours before the procedure,
  • First blood draw attempt is successful,
  • Those who are considered healthy by the physician in the health follow-ups performed after birth

排除标准

  • Those with congenital anomalies,
  • Having any disease,
  • Patients whose intravenous blood collection attempt takes more than two minutes,
  • Babies previously monitored in the Neonatal Intensive Care Unit will be excluded from the scope of the research.

结局指标

主要结局

Preterm Pain

时间窗: 5 minutes. At the first mınute of venipuncture Scores will be given between 0-7 points.

Neonatal İnfant Pain Scale

Preterm Crying

时间窗: 5 mınutes. During blood collection, the stopwatch will turn on when the baby starts crying and turn off when the baby stops crying.

Stopwatch

次要结局

  • Heart Rate(1.Five minutes before the blood collection procedure, 2. In the first minute of the blood collection process 3. Five minutes after the blood collection procedure)
  • Oxygen Saturatıon(1.Five minutes before the blood collection procedure, 2. In the first minute of the blood collection process 3. Five minutes after the blood collection procedure)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

DERYA KILINÇ

Assisstant Professor

Istanbul University - Cerrahpasa (IUC)

研究点 (2)

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