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临床试验/NCT06345742
NCT06345742已完成不适用

The Effect of Parental Participation on Newborn Comfort During Diaper Care Practice in Preterm Infants

Acibadem University2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2023年12月19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
105
试验地点
2
主要终点
Change in Level of Comfort

研究概览

简要总结

It was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants.

H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort.

H2: There is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants.

H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants.

详细描述

The expectation of all parents is to have a healthy baby at the end of the pregnancy. However, newborns being born unexpectedly early and being admitted to the neonatal intensive care unit is a stressful situation for both newborns and parents. During this process, parents of preterm infants experience anxiety, loss of control, fear of the future, depression, role change and concerns about the improvement of the baby's condition. It is important for parents to actively participate in care within the framework of family-centered care practices in order to reduce the newborn's stress level, increase its comfort and improve its environment and to increase the families' ability to cope with this situation.Infant care, which is repeated many times a day in the Neonatal Intensive Care Unit, is one of the care practices that include tactile stimuli. Studies have observed that preterm infants' stress increases during diaper changes. For this reason, it is important to plan the necessary invasive practices to increase comfort during diaper changes, to include parental participation in these procedures, and to determine the effect of these interventions on the infants' comfort and to include them in the literature.

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 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Infants whose gestational age is between ≥34 weeks and ≤36+6 weeks at the time of application
  • Infants with stable health conditions

排除标准

  • Intubated
  • Those with very low and extremely low birth weight at the time of procedure
  • Having a chronic disease
  • Those with congenital anomalies
  • Having undergone a surgical procedure
  • Having neurological symptoms
  • Receiving oxygen support
  • Diagnosed with sepsis
  • A pharmacological analgesic method was used four hours before.
  • Parents who do not want to participate in care

结局指标

主要结局

Change in Level of Comfort

时间窗: immediately before the procedure, during the procedure, immediately after the procedure. The change in these time intervals will be assessed

The infants' comfort level will be measured using the Premature Infant Comfort Scale.The scale is a multi-dimensional scale used to measure comfort in preterm newborns. The Premature Infant Comfort Scale was developed by Monique et al. in the Netherlands in 2007. The validity and reliability of the Turkish scale was determined by Küçük Alemdar and Güdücü Tüfekçi in 2015. The scale consists of 1 to 5 rating points. The infant's comfort is evaluated based on the total score according to the scale. According to the total score, 35 indicates the lowest score, 7 indicates the highest comfort level, and a high score indicates a low comfort level. The subscales of the scale include the preterm infant's alertness, calmness, respiratory status, physical movement, muscle tone, facial movements, and average heart rate

Level of Parental Stress

时间窗: It will be measured once just before the diaper care

The level of parental stress will be measured using the Neonatal Intensive Care Unit Parental Stress Scale.The scale was developed by Miles, Funk and Carlson in 1993 to determine the perception levels of stressors arising from the physical and psychosocial environment by mothers and fathers. The Turkish validity and reliability study of the scale was conducted by Turan and Başbakkal in 2006. The scale consists of 5 rating points and is rated from 1 (not stressful) to 5 (extremely stressful). The score that can be obtained from the scale varies between 0 and 170. The scale can be applied to mothers and fathers with infants in the neonatal intensive care unit

次要结局

未报告次要终点

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zehra Kan Onturk

Assist. Prof.

Acibadem University

研究点 (2)

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