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临床试验/NCT06725914
NCT06725914进行中(未招募)不适用

The Effect of Kangaroo Father Care Transport on Physiological Parameters, Anxiety and Paternal Attachment in Preterm Infants: A Randomized Controlled Study

Zeynep Büşra GÜÇLÜ1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
Physiological Parameter Monitoring Form-Heart Rate

研究概览

简要总结

This study was planned to investigate the effect of paternal kangaroo care and transport on physiologic parameters, anxiety and paternal attachment in preterm infants.

详细描述

This study was conducted to determine the effects of paternal kangaroo care and transport of preterm infants on the physiologic parameters of the infant and the anxiety and attachment levels of the fathers.

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
Single (Outcomes Assessor)

盲法说明

In this study, statistician blinding was used for the implementation of randomization and data analysis.

入排标准

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

入选标准

  • •Neonatal related;
  • •Born by caesarean section,
  • •Born at 34-36+6 weeks gestation,
  • •Apgar score of 7 and above at 1 and 5 minutes,
  • •Stable and healthy,
  • •Infants with a body weight of 1500 g and above were included. It's about the father;
  • •Who volunteered to participate in the study,
  • •No mental and psychological problems,
  • •No communication problems (speech, hearing and severe visual impairment),
  • •Fathers who did not carry contact-transmitted diseases (Covid-19, herpes simplex, scabies, etc.) were included.

排除标准

  • •Congenital anomalies,
  • •Abdominal defects such as ompholocele, diaphragmatic hernia, gastroschisis,
  • •Receiving invasive and noninvasive respiratory support,
  • •With chest tube and umbilical catheter,
  • •Foreign babies and their fathers were ostracized.

研究组 & 干预措施

Implementation of paternal early kangaroo care transport

Experimental

Early kangaroo care was administered immediately after delivery. The fathers were seated on a wheelchair for transportation from the gynecology operating room to the NICU. The newborn was then dressed in a diaper and hat. The preterm baby was laid naked on the father's bare chest in an upright position. Preterms were secured with a kangaroo care garment in the frog leg position in the prone position with the head turned to the side. The baby was covered with a blanket to prevent heat loss.

干预措施: kangaroo care (Behavioral)

Control Group

No Intervention

The babies in the control group were transported to the NICU in the arms of the nurse after birth as in the clinical routine.

结局指标

主要结局

Physiological Parameter Monitoring Form-Heart Rate

时间窗: 3 minutes before the intervention

Heart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.

Physiological Parameter Monitoring Form-SPO2

时间窗: 3 minutes before the intervention

SPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.

Physiological Parameter Monitoring Form-Body temperature (°C)

时间窗: 3 minutes before the intervention

Body temperature (°C) in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.

Father-Infant Information Form-Paternal characteristics, maternal characteristics and infant characteristics

时间窗: 15 minutes before the intervention

Paternal characteristics (age, number of children, educational status, employment status, income status and kangaroo care experience), maternal characteristics (age, educational status, employment status, health problems during pregnancy) and infant characteristics (date of birth, gestational week, gender, birth weight, birth length, birth head circumference, APGAR score, type of anesthesia at birth) were recorded before the intervention.

State Anxiety Scale

时间窗: 15 minutes before the intervention

State Anxiety Scale was recorded 15 minutes before the intervention.

Father-Infant Attachment Scale

时间窗: 15 minutes before the intervention

Father-Infant Attachment Scale was recorded 15 minutes before the intervention.

次要结局

  • Physiological Parameter Monitoring Form-Heart Rate(3 minutes after initiation of transport with kangaroo care.(T1))
  • Physiological Parameter Monitoring Form-SPO2(3 minutes after initiation of transport with kangaroo care.(T1))
  • Fizyolojik Parametre İzleme Formu-SPO2(3 minutes after the end of kangaroo care (T2))
  • Physiological Parameter Monitoring Form-Body temperature (℃)(3 minutes after initiation of transport with kangaroo care.(T1))
  • Physiological Parameter Monitoring Form-Body temparature (℃)(3 minutes after the end of kangaroo care (T2).)
  • State Anxiety Scale(15 minutes before the intervention (T2))
  • Father-Infant Attachment Scale(15 minutes after the intervention.)
  • Physiological Parameter Monitoring Form-Heart Rate(3 minutes after the end of kangaroo care (T2).)

研究者

发起方
Zeynep Büşra GÜÇLÜ
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zeynep Büşra GÜÇLÜ

Nurse

Selcuk University

研究点 (1)

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