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临床试验/NCT06136130
NCT06136130已完成不适用

The Effect of Positioning With Material and Hand-Face Maneuver on Physiological Parameters and Stress Symptoms in Preterm Newborns

Kirsehir Ahi Evran University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年9月1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
60
试验地点
2
主要终点
Newborn Position Assesment Tool

研究概览

简要总结

The study was administered in a randomized controlled experimental design to evaluate the effects of material positioning and hand-face maneuver on physiological parameters and stress symptoms in preterm newborns with gestational weeks 28 to 32. The sample of the study consisted of 60 preterm infants who met the selection criteria in newborn intensive care unit between September 2018 and July 2020.The newborns in the control group (n=30) were given a "nesting with a rolled up blanket" position, as in the routine of the ward. The Experimental Group1 (n=30) was given positions using a "positioner" and the same newborns (Experimental2) was given positions using "positioner and hand-face maneuver" on the second day of the study.

详细描述

The universe of the study consisted of preterm newborns patients who met the selection criteria in newborn intensive care unit.The research was planned as a randomized controlled experimental study. In order for the groups to be distributed homogeneously, the order produced by a computer program (http://www.randomizer.org/) was used. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list. The control variable of the study is demographic characteristics of the baby. The dependent variables of the study are physiological parameters, newborn position assesment tool score and newborn stress scale score In the research, "Information and follow-up form" prepared by the researcher in line with the literature was used as data collection tools. Newborn Position Assesment Tool and Newborn Stress Scale were also used

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
28 Weeks 至 32 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm newborn between 28-32 weeks of gestation (very early preterm)
  • Not connected to mechanical ventilator
  • Parent's consent with informed consent form

排除标准

  • Presence of congenital anomalies, a known infection, neuromuscular problems and genetic anomalies in a preterm newborn
  • Have undergone any surgical intervention
  • Painful procedure (invasive procedure, etc.) performed in the last hour
  • Taking analgesics in the last six hours

结局指标

主要结局

Newborn Position Assesment Tool

时间窗: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

The Infant Position AssessmentTool (IPAT) is a six-item(shoulders, hands, hips, knees,ankles, feet, head, neck) tool with cumulative scores ranging from 0 to 12. A scale score of 12 indicates that the position is given very well, and a score of 0 indicates that the position is very bad.

Newborn Stress Scale

时间窗: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

Scale items were collected in 8 subgroups. These subgroups consist of a total of 24 items in 3-point Likert type, including facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, and posture.A minimum of 0 points and a maximum of 16 points are taken from the scale. As the score increases, the baby's stress level increases.

Respiratory rate assesment

时间窗: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

respiratory rate/min,

Pulse rate assesment

时间窗: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

Pulse rate/min

Oxygen saturation assesment

时间窗: Before starting position, after 1 hour 1st position , before second positon, after 1 hour second position

Oxygen saturation %

次要结局

未报告次要终点

研究者

发起方
Kirsehir Ahi Evran University
申办方类型
Unknown
责任方
Principal Investigator
主要研究者

Isıl AR

Research Assistant

Kirsehir Ahi Evran University

研究点 (2)

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