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临床试验/NCT05434364
NCT05434364已完成不适用

Comparison the Effects of Facilitated Tucking, Swaddling and Prone Position Applied During Endotracheal Aspiration on Pain, Comfort and Physiological Parameters in Preterm Infants

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2024年2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
已完成
发起方
入组人数
100
试验地点
2
主要终点
physiological parameter (oxygen saturation)

研究概览

简要总结

Stress and pain control are vital for newborns, especially preterm babies. While painful procedures cause physiological changes in the short term, they negatively affect brain development in the long term. Non-pharmacological interventions with proven efficacy include: fetal position, sucrose, breastfeeding, breast milk, maternal presence, non-nutritive sucking, swaddling (wrapping) and skin-to-skin contact, as well as developmentally supportive positioning. Evaluating the effectiveness of nursing practices to be performed on babies, scientifically proving the most beneficial application that will both alleviate pain and increase their comfort in painful procedures such as aspiration and being more beneficial to babies are among the most basic benefits. Thanks to these applications, it is predicted that your baby will experience less pain and provide more comfort. Therefore, this study aim to comparison the effects of facilitated tucking, swaddling and prone position applied during endotracheal aspiration on pain, comfort and physiological parameters in preterm infants.

详细描述

The universe of the research; between July-September 2022, patients who are intubated on a mechanical ventilator at 32-36 weeks of gestation (middle preterm group) in Gaziantep Cengiz Gökçek Obstetrics and Pediatrics Hospital Neonatal Intensive Care Unit will consist of. In order to determine the sample size of the study, power analysis was performed using the G*Power (V3.1.9.7) program. According to Cohen's effect size coefficients; Assuming that the effect size (f = 0.4) of the evaluations to be made between four independent groups will be large/large, Taplak and Bayat (2021) found the effect size as 0.932 as a result of the Power analysis based on the PIPP-R results. In this study, it was determined that there should be at least 15 people in all groups (Fetal position, Swaddling, Prone position and control group) according to the new calculation made with 0.932 effect size, 5% alpha (two-sided) and 99% power. Considering that there may be losses during the study, each group will form a sample of 100 infants, 25 infants each. Random assignment of babies to groups will be carried out by the researcher through a computer program (https://www.randomizer.org)/. After determining the groups of premature babies randomly, one group will be given fetal position, one group swaddling position and one group prone position before, during and after endotracheal aspiration. Pain scores (PIPP-R), comfort scores (Comfort Scale) and physiological parameters (Heart peak beat, oxygen saturation value measured by pulse oximetry) 3 minutes before, during and after these nursing practices in the 1st and 3rd minutes after the procedure.

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
Double (Participant, Care Provider)

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

  • Having 28-35 weeks of gestation,
  • Follow-up as intubated in SIMV mode on mechanical ventilator,
  • Follow-up on a ventilator between 1-10 days,
  • Having a body weight of ≥1000 g,
  • Those who have not taken any opioid or sedative medication until 4 hours before the procedure will be included.

排除标准

  • Presence of congenital anomaly,
  • Chest tube inserted
  • Intracranial bleeding,
  • Presence of condition/anomaly that will prevent prone tilting,
  • Those with a history of epileptic seizures will be excluded.

研究组 & 干预措施

Facilitated Tucking

Experimental

giving facilitated tucking before, during and after the procedure

干预措施: Facilitated Tucking (Other)

Swaddling

Experimental

giving swaddling before, during and after the procedure

干预措施: Swaddling (Other)

Prone position

Experimental

giving prone position before, during and after the procedure

干预措施: Prone Position (Other)

control

No Intervention

Rutin care in the neonatal intensive care unit

结局指标

主要结局

physiological parameter (oxygen saturation)

时间窗: 6 minutes

Comfort score

时间窗: 6 minutes

Newborn Comfort Behavior Scale (min=6 max=30, High scores signify that the infant is not comfortable)

Pain scores

时间窗: 6 minutes

Premature infant pain profile-revised (PIPP-R) (min=0 max=21, the higher the score, the more severe the pain)

physiological parameter (Heart rate)

时间窗: 6 minutes

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

SERAP ÖZDEMİR

Doctor

Istanbul University - Cerrahpasa

研究点 (2)

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