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临床试验/NCT05673213
NCT05673213已完成不适用

The Effects of Three-Stair Positioning Pillows Used for Preterm Infants on Physiological Parameters and Sleep-Wakefulness Status

Harran University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Physiological Parameters (oxygen saturation /%)

研究概览

简要总结

This research was carried out between December 2021 and May 2022 as a randomized controlled experimental design. In the study, between 28-35 weeks of gestation preterm infants were divided into two groups as the experimental group (n=30) and the control group (n=30). The block randomization method was used to ensure that the infants were similar in terms of both weeks and weight due to the large interval between the weeks and to ensure the balance between the groups. Infants in the control group were followed in the routine prone position of the neonatal intensive care unit, while infants in the experimental group were followed in the prone position with three-stair positioning pillows.

详细描述

This research was carried a randomized controlled experimental design. The sample size in the study was 1.08, type 1 error was 5%, and statistical power was 95%, according to the power analysis performed by taking into account the Breathing frequency values of the groups in the study called "Effectiveness of Hammock Positioning in Reducing Pain and Improving Sleep-Wakefulness State in Preterm Infants". It was calculated as a total of 48 participants, 24 in each group (Ribas et al., 2019). Considering the possibility of losses, 30 preterm infants with TSPP (experimental) and 30 preterm infants who were not used (control) were included and the infants were randomly assigned to the groups. The block randomization method was used to ensure that the infants were similar in terms of both weeks and weight due to the large interval between the weeks and to ensure the balance between the groups. Infants were divided into 2 groups as 28-31 week gestation and 32-35 week gestation. 30 infants were randomly distributed to each gestational week group as experimental and control groups through a program available at http://www.randomizer.org. Families were informed by the researcher about the method of the study through face-to-face interviews, written and verbal consents were obtained, and the information about preterm infants and their families was recorded in the "Information Form". The actigraphy measuring device was connected to the computer and the device was installed by entering the parameters such as the name and surname of the infant to be treated and the time interval in which the recordings would be made. Data were collected from a single hall in the NICU. The noise level of the intensive care unit (NICU) was measured with the Uni-T UT353 Mini Decibelmeter Device and the average noise level of the hall where the data were collected was between 50-55 dB. The infant was cared for, fed and treated by the primary nurse responsible for the infant between 08:30 and 08:55. No intervention was made to the preterm infant between 09:00-12:00 and the infant was allowed to rest. Between these hours, the oxygen saturation and heart rate of the preterm infants in both groups were counted by the researcher with a pulse oximeter device and recorded 18 times in 10 minutes. Sleep-wakefulness status was recorded by taking 15-second recordings with the Actigraphy measuring device. Preterm infants in the experimental group were followed in the prone position with three-stair positioning pillows and the infants in the control group were followed in the routine 15º head raised prone position between the hours of the research follow-up. The study followed the CONSORT guideline for reporting randomized controlled trials.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
28 Weeks 至 35 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Only being diagnosed as preterm as a result of the examination performed by the physician,
  • Parent's willingness to participate in the research,
  • The infant is between 28-35 weeks of gestation,
  • Being in appropriate weight according to the week of gestation,
  • Having a history of intubation and being extubated.

排除标准

  • Surgical procedure has been applied,
  • Diagnosed with sepsis,
  • Congenital anomaly,
  • Taking analgesics 4 hours before, which may affect sleep,
  • Having hyperbilirubinemia,
  • Having hypoglycemia,
  • Presence of intracranial bleeding,
  • Receiving any oxygen support (nasal O2, incubator O2, etc.),
  • Intubated infants were not included in the study.

结局指标

主要结局

Physiological Parameters (oxygen saturation /%)

时间窗: 3 hours

Measurements were made with an actigraphy device between 09:00 and 12:00.

Sleep Status/minute

时间窗: 3 hours

Between 09:00-12:00

Wakefulness Status/minute

时间窗: 3 hours

Measurements were made with an actigraphy device between 09:00 and 12:00.

Physiological Parameters (heart rate/minute )

时间窗: 3 hours

Between 09:00-12:00

Physiological Parameters (respiratory rate/minute )

时间窗: 3 hours

Between 09:00-12:00

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma BOZDAG

Lecturer Doctor

Harran University

研究点 (1)

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