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临床试验/NCT06320587
NCT06320587招募中不适用

Determination of the Effect of Kangaroo Care Applied to Premature Newborns by Their Parents on the Newborn's Vital Signs, Parents' Perceived Parenting Self-Efficacy Level and Infant Attachment

Saglik Bilimleri Universitesi2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Postnatal Paternal-Infant Attachment Questionnaire

研究概览

简要总结

This study was planned to determine the effect of kangaroo care applied by parents of premature newborns in the neonatal intensive care unit on the newborn's vital signs, perceived parenting self-efficacy level and attachment to the baby.

详细描述

The research is a randomized controlled trial and an experimental research design will be used. The research will be carried out with two groups as experimental (newborns given kangaroo care by both mother and father) and control (newborns given kangaroo care only by the mother) groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Parents who volunteered to participate in the research
  • Parents who are Turkish citizens and speak Turkish
  • Preterm baby born between 28-37 weeks staying in the neonatal intensive care unit
  • The mother and father do not have any obstacles in taking care of the kangaroo.
  • Mothers and fathers who can come to the hospital regularly on the specified days will be included in the study.

排除标准

  • Not volunteering to participate in the research
  • Parent's inability to speak Turkish
  • Presence of a life-threatening major malformation or serious perinatal complication in the premature baby
  • Babies with umbilical catheters and central venous catheters will not be included in the study.

研究组 & 干预措施

Control group

Placebo Comparator

Newborns in this group will be given kangaroo care by only the mother.

干预措施: Kangaroo care practice only mother (Other)

Experimental group

Experimental

Newborns in this group will be given kangaroo care by both their mother and father.

干预措施: Kangaroo care practice by both mother and father (Other)

结局指标

主要结局

Postnatal Paternal-Infant Attachment Questionnaire

时间窗: It will be filled in before kangaroo care and after 5 weeks of kangaroo care.

It will be applied to measure fathers' attachment levels to their babies. The lowest score that can be obtained from the scale is 18 and the highest score is 90.A high score from the scale indicates high bonding.

Perceived Father Parenting Self-Efficacy Form

时间窗: It will be filled in before kangaroo care and after 5 weeks of kangaroo care.

It is aimed to determine the change in fathers' perceived parenting self-efficacy levels. The lowest score that can be obtained from the form is 0 and the highest score is 10. As the score increases, the degree of self effiacy in father increases.

Physiological parameters of the premature infant: peak heart rate (BPM)

时间窗: Change from baseline at 5 weeks.

It shows heart rate per minute of the infant. The normal peak heart rate should be between 100-160 BPM.

Mother-To-Infant Bonding Scale

时间窗: It is designed to be applied from the first day after birth. It will be filled in before kangaroo care and after 5 weeks of kangaroo care.

It will be applied to evaluate the mother's attachment level to her baby. The lowest score that can be obtained from the scale is 0 and the highest score is 24. The higher the score from the scale, the more it indicates a mother-infant attachment problem.

Perceived Mother Parenting Self-Efficacy Scale

时间窗: It will be filled in before kangaroo care and after 5 weeks of kangaroo care.

It will be applied to measure mothers' perceived parenting self-efficacy. The scale consists of 3 sub-dimensions. These; care procedures, the belief in developing positive baby behaviors, the belief in recognizing the baby's behavior, and mother-baby interaction. The lowest score that can be obtained from the scale is 18 and the highest score is 72.As the score obtained increases, the degree of self-efficacy in mothers increases.

Physiological parameters of the premature infant: body temperature (°C)

时间窗: Change from baseline at 5 weeks.

It shows body temperature of the infant. The normal body temperature of premature babies should be between 36,5 °C and 37,4 °C.

Physiological parameters of the premature infant:Respiration rate (RPM)

时间窗: Change from baseline at 5 weeks.

It shows respiratory rate per minute of the infants. The normal respiratory rate of premature babies should be in the range of 40-60 RPM.

Physiological parameters of the premature infant: oxygen saturation (%)

时间窗: Change from baseline at 5 weeks.

Oxygen saturation measures the percentage of oxyhemoglobin in the blood. The normal oxygen saturation should be between % 88 - % 100.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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