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临床试验/NCT06513897
NCT06513897已完成不适用

The Effects of Acupressure and Paternal Holding on Pain and Physiological Parameters in Infants During Heel Lancing: a Randomized Controlled Trial

Baskent University2 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2024年8月15日最近更新:
适应症

试验速览

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

研究概览

简要总结

Neonatal heel blood collection is a common medical procedure to obtain blood samples from newborns for diagnostic purposes. Although necessary for clinical evaluation, this procedure causes discomfort and distress in infants. The pain experienced during heel prick is a major concern and warrants exploration of effective and compassionate interventions to alleviate associated discomfort and reduce crying time. Non-pharmacological approaches, such as acupressure and cuddling, are thought to have important contributions to improving the overall experience of newborns undergoing this procedure. . The aim of this study was to evaluate the efficacy of acupressure and paternal hugging interventions in relieving pain and reducing crying time during neonatal heel haemorrhage. The choice of these interventions was based on their potential to offer non-invasive and holistic approaches to pain management by addressing not only the physical but also the emotional dimensions of the neonatal experience.

详细描述

Neonatal heel prick blood collection is a common medical procedure performed to obtain blood samples from newborns for diagnostic purposes. Neonatal heel prick plays an important role in the diagnosis of genetic and metabolic diseases such as hypothyroidism and phenylketonuria. Although necessary for clinical evaluation, this procedure causes discomfort and distress in infants. Pain during heel prick is a major concern and warrants exploration of effective and compassionate interventions to alleviate the associated discomfort and reduce crying time. In this sense, there are studies on both heel prick instruments and interventions applied to the infant during heel prick. Non-pharmacological approaches such as acupressure and hugging are thought to have important contributions to improving the overall experience of newborns undergoing this procedure. It is known that one of the most important determinants of attachment in the postnatal period is touch, hugging and skin-to-skin contact. The neonatal period is a critical developmental stage characterised by rapid physiological and neurological changes. It is thought that the sensitivity of newborns to pain and early painful experiences may have potential long-term effects. There are studies suggesting that painful procedures may be effective in mother-baby or father-baby attachment. While there are studies in the literature on mother's hug, no study on father's hug was found. Due to the role of the presence of fathers in paediatric pain management, the potential to provide emotional support, the father's hug as a form of comforting touch, contributing to the release of oxytocin, a hormone associated with attachment and stress reduction, and the emotional bond established through hugging may act as a buffer against distress associated with painful procedures and promote a sense of security and assurance in the infant, it was considered appropriate to use it in this study. Acupressure, derived from traditional Chinese medicine, involves applying manual pressure to specific points on the body to promote healing and relieve pain. Similarly, emotional support provided by a carer, such as a father, through cuddling is thought to have the potential to reduce stress and improve the infant's emotional well-being. In this study, investigators aimed to evaluate the effectiveness of acupressure and paternal hug interventions in relieving pain and reducing crying time during neonatal heel haemorrhage. The choice of these interventions was based on their potential to offer non-invasive and holistic approaches to pain management by addressing not only the physical but also the emotional dimensions of the neonatal experience.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
0 Days 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Being a term newborn
  • A healthy newborn with its mother by its side
  • Not taking any analgesic/sedative medication within 24 hours
  • The baby has not undergone invasive procedures other than routine interventions

排除标准

  • Preterm-postterm newborn
  • Having a systemic disease
  • Taking analgesic/sedative medication in the last 24 hours
  • Invasive procedures other than routine interventions

结局指标

主要结局

Pain Score

时间窗: pre-intervention, immediately after the intervention

Pain will be assessed using the Neonatal Pain, Agitation, Sedation Scale. The minimum score of the scale is 0 and the maximum score is 10. Four points and below is considered as mild pain, five points and above is considered as moderate and severe pain.

Crying time

时间窗: During the intervention

Crying time will be recorded throughout the procedure.

Saturation value

时间窗: pre-intervention, immediately after the intervention

Saturation value will be assessed using the infant pulse oximeter.

Pulse value

时间窗: pre-intervention, immediately after the intervention

Pulse value will be assessed using the infant pulse oximeter.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilcim Ercan Koyuncu

Principal Investigator

Baskent University

研究点 (2)

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