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临床试验/NCT05080582
NCT05080582已完成不适用

Does Mother Scented Simulated Hand Promote Comfort, Reduce Pain and Distress Among Mechanically Ventilated Preterm Neonates During Invasive Procedures

Alexandria University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年3月24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
62
试验地点
2
主要终点
Level of comfort, pain and distress

研究概览

简要总结

This study aimed to determine the effect of Mother-Scented Simulated Hand (MSSH) on promoting comfort among mechanically ventilated preterm neonates during invasive procedures.

Research Hypotheses

  • Preterm neonates who receive MSSHH exhibit higher levels of comfort during invasive procedures than those who receive standard care.
  • Preterm neonates who receive MSSHH exhibit lower levels of pain and stress during invasive procedures than those who receive standard care

详细描述

A quasi-experimental, pre-posttest, two group, study was carried out in NICU of in Smouha, Alexandria. A sample of 62 mechanically ventilated neonates were randomly assigned to two equal groups; the study group wrapped with a warm MSSH during the invasive procedures while the control group received standard care of NICU. Two observers independently rated the neonates' level of comfort, distress, and pain during Endotracheal Suctioning (ETS) and heel prick using COMFORTneo Scale.

On day one of mechanical ventilation, the neonates received the same standard care of the NICU, while they wrapped with a warm Mother-Scented Simulated Hand as follow; simulated hand was scented with mothers' body odor by placing it on the mothers' bare chest or behind the neck for one hour. Then, the MSSH was placed under a radiant warmer for a couple of minutes to reach the mothers' unique warm touch. Inside the incubator, the mechanically ventilated neonates were placed in a side-lying flexed fetal position, where they encircled with the two warm simulated human hand to contain them. Where the palm of one MSSH cupped the neonates' head, and the palm of the other hand cupped the lower part of body and extremities. The neonates were kept in such a position throughout the mentioned invasive procedures. Neonates' physiological response, comfort, distress, and pain levels were assessed the same way as the first day.

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 (Participant)

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Newly admitted
  • Hemodynamic stability

排除标准

  • Receiving sedatives
  • Low APGAR score lower than three at five minutes
  • Hypothermia
  • Hypoglycemia
  • Hyperglycemia
  • Intraventricular hemorrhage grade III& IV
  • Neonatal seizures

结局指标

主要结局

Level of comfort, pain and distress

时间窗: immediately after the intervention

COMFORTneo Scale: This scale was developed by Dijk et al. (2009). It is a numerical rating scale to assess neonates' comfort, distress and pain levels. It consists of 6 items, including alertness, calmness/agitation, respiratory response, body movement, facial tension, and muscle tone. The neonates' behavioral response was rated on 5 points numerical rating scale (1-5), and the total score ranged from 6 to 30. The lower score indicates a higher level of comfort and vice versa. The COMFORTneo scale has additional two Numerical Rating Scales (NRSs) for pain and distress. These scales are scored after the COMFORTneo score. Both of them range from zero to ten; the Zero score represents no pain or distress, while the ten score represents the worst imaginable pain or distress.

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

Zohour Ibrahim Mahmoud Rashwan

Pediatric nurse specialist, Faculty of Nursing, principal Investigator, lecturer

Alexandria University

研究点 (2)

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