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临床试验/NCT06622330
NCT06622330已完成不适用

The Effect of Position Change on Pain and Cerebral Oxygen Saturation After Endotracheal Aspiration

Istanbul Medipol University Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年1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
70
试验地点
2
主要终点
Behavioral Pain Scale

研究概览

简要总结

This study is a randomized controlled experimental study to investigate the effect of position change on pain and cerebral oxygen saturation after endotracheal aspiration in pediatric patients.

详细描述

This study is a randomized controlled experimental study to investigate the effect of position change on pain and cerebral oxygen saturation after endotracheal aspiration in pediatric patients. The study sample consisted of 70 pediatric patients (35 in the control group and 35 in the intervention group) who met the inclusion criteria and whose parents gave informed consent. The research data were collected using the "Child Identification Form" and the "Behavioral Pain Scale". SPSS 24 program was used to analyze the data obtained in the study. Children in the experimental group were given 30 minutes of wrapping and 30 minutes of fetal position after aspiration. Children in the control group did not receive any treatment.

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 (Investigator)

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients whose consent form is signed by their legal guardian
  • Intubated pediatric patients receiving mechanical ventilation support
  • Non-sedatized pediatric patients
  • Pediatric patients who have received only paracetamol and whose duration of action has exceeded 4-6 hours

排除标准

  • Unconscious pediatric patients
  • Pediatric patients receiving pharmacologic drugs other than paracetamol
  • Unstable pediatric patients
  • Pediatric patients with painful procedures during the procedure

结局指标

主要结局

Behavioral Pain Scale

时间窗: Measured before aspiration, 1 and 2 hours after aspiration. Each measurement lasted 10 minutes.

Determines the pain level of children. In this scale, there are three items including facial expression, upper extremities and ventilator compliance and four variables including behavioral responses to pain in each item. These are; facial expression (relaxed, partially relaxed, fully tense, grimace), upper extremities (no movement, partially flexed, fully flexed), fingers (flexed, continuously retracted), compliance with ventilation (tolerates ventilation, coughs, but often tolerates ventilation, fights with ventilator, cannot control ventilation). Each question is given a score between 1-4. The lowest score is 3 and the highest score is 12. The higher the score, the more severe the pain.

Cerebral oxygen saturation

时间窗: Measured before aspiration, 1 and 2 hours after aspiration. Each measurement lasted 10 minutes.

It was measured to determine the cerebral oxygen saturation of children.

次要结局

未报告次要终点

研究者

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

aysel kokcudogan

Ph.D., Asst. Prof.

Istanbul Medipol University Hospital

研究点 (2)

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