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临床试验/NCT06400446
NCT06400446招募中不适用

The Effect of Kangaroo Care on Vital Signs of Infants After Cardiac Surgery

Istinye University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2023年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Change in oxygen saturation

研究概览

简要总结

The aim of this study was to investigate the effects of kangaroo care on the vital signs of infants undergoing cardiac surgery.

Hypothesis 1 (H1): Oxygen saturation levels of babies who are given kangaroo care are higher than babies who are not given kangaroo care.

Hypothesis 2 (H2): The peak heart rate of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.

Hypothesis 3 (H3): The respiratory rate of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.

Hypothesis 4 (H4): The arterial blood pressure of infants who receive kangaroo care is lower than infants who do not receive kangaroo care.

Hypothesis 5 (H5): The pain score of infants who received kangaroo care is lower than infants who did not receive kangaroo care.

详细描述

Kangaroo care has been found to be a feasible intervention before and after cardiac surgery to support infants with congenital heart disease, but it has been stated that formal standards and procedures need to be developed to transform kangaroo care into practice. Skin-to-skin contact is a low-cost, low-risk intervention that supports comfort and contributes to physiological stability in infants before and after neonatal cardiac surgery. It positively affects the pain level of infants. Clinical studies on the application of kangaroo mother care on infants undergoing cardiac surgery are limited 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 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • The gestational week of the infant is greater than 37 weeks
  • Cardiac surgery operation within the first 30 days of life
  • The infant's chest incision is closed

排除标准

  • The infant has non-cardiac congenital defects or syndrome
  • Intubation of the infant

结局指标

主要结局

Change in oxygen saturation

时间窗: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.

Oxygen saturation will be monitored.

Change in heart rate

时间窗: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.

Heart rate will be monitored.

Change in respiratory rate

时间窗: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.

Respiratory rate will be monitored.

Change in blood pressure

时间窗: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.

Blood pressure will be monitored.

Change in level of pain

时间窗: Data will be collected immediately before care is given, at 15 minutes during care, and at 15 minutes after care is given. The change in these time intervals will be evaluated.

The infants' pain level will be measured using the CRIES(Crying, Requires O2, Increased vital signs,Expression, Sleepless). The scale is used in the evaluation of postoperative pain in premature babies (between 32-36 weeks of gestation) and postoperative pain. Starting from the thirty-second gestational week, it is preferred in neonates and children between 6 months, especially in intensive care units.The Scale was developed by Krechel \& Bildner, 1995. Crying status, oxygen saturation, heart rate and/or blood pressure, facial expression and sleep status are the parameters used in the evaluation. Each parameter is scored out of two; a score of 3-4 indicates mild to moderate pain; values of five and above indicate severe pain.

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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