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临床试验/NCT05580874
NCT05580874已完成不适用

Investigation of the Effect of Massage on Stress Behaviors and Salivary Cortisol Levels in Premature Babies

Izmir Katip Celebi University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2022年6月17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
40
试验地点
2
主要终点
"Newborn Stress Scale"

研究概览

简要总结

The practices of the neonatal intensive care unit that reduce the stress of premature babies and respond to behavioral cues have a positive effect on the development of newborns. The stress experienced by premature infants affects the baby's behavior and laboratory findings. Massage is an effective application in facilitating the adaptation of premature babies to extrauterine life and ensuring that they are least affected by adverse environmental conditions. Massage in premature babies has an important place in reducing stress and supporting psychological, mental and physiological development as a healthy tactile stimulus.

详细描述

This study was planned to examine the effects of massage on stress behaviors and salivary cortisol levels in premature infants. The research was planned on a randomized controlled experimental. In the research, the group to which massage will be procedure is the experimental group, and the group to which the swaddling procedure will be the control group will form.

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
30 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Families being voluntary to participate in the study
  • Babies being born between 30 and 36 weeks plus 6 days of gestation
  • Postnatal 3-
  • premature babies between days
  • Not taking analgesics or sedatives
  • Absence of congenital anomaly
  • Absence of skin disease
  • The premature babies passing to oral feeding
  • Not having a proven sepsis diagnosis
  • No need for mechanical ventilator support

排除标准

  • Having a congenital anomaly
  • Presence of skin disease
  • Having intracranial bleeding
  • Having sepsis
  • Receiving phototherapy
  • Taking analgesic / sedative type drugs

结局指标

主要结局

"Newborn Stress Scale"

时间窗: After the swaddling

Salivary cortisol levels

时间窗: 30 minutes after swaddling

次要结局

  • Baby's oxygen saturation(A minutes after swaddling)
  • Baby's heart rate(A minutes after swaddling)
  • Baby's respiratory rate(A minutes after swaddling)
  • Baby's body temperature(A minutes after swaddling)

研究者

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

Pınar Dogan

RN, MSc

Izmir Katip Celebi University

研究点 (2)

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