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临床试验/NCT05064072
NCT05064072已完成不适用

The Evaluation of Pain Felt During Removal of the Products From Infant's Skin Used in Nasogastric Tube Fixation: Randomized Controlled Study

Marmara University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年7月1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
入组人数
120
试验地点
1
主要终点
Water-based barrier tape

研究概览

简要总结

The present study was planned to evaluate the pain of 4-6 weeks infants felt during removal of the adhesive products from newborn's skin used in the fixation of nasogastric tube in neonatal and infant units. The hypothesis of the study is "Water-based barrier tape is more effective to reduce pain than hydrocolloid barrier tape.

详细描述

The study was planned as randomized controlled and experimental design to compare the efficiency of three different methods reducing pain during removal adhesive products for 4-6 weeks infants. The universe of the study consisted of 4-6 weeks infants in neonatal and infants clinics of Giresun Women's and Children's Hospital between the dates of July-September 2021. Power analysis was performed through G*Power (v3.1.7) programme in order to determine the number of the sample. At the beginning of the study, a reference study (Kemer, 2020) was used for sample calculation. The effect size was calculated as d=0.561 regarding the assessment of skin condition scores and 120 participants in total should be included in the study as 40 participants for each groups in order to obtain 80% power in the level of α=0.05. Block randomization technique is applied in the study as a randomization method. "As for data collection "Infant description form" and "Neonatal Infant Pain Scale" was used. The scale was filled by two independent observer via double-blind method.

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
4 Weeks 至 6 Weeks(Child)
性别
All
接受健康志愿者
是

入选标准

  • •All the 4-6 weeks infants including interventional process and without any skin diseases

排除标准

  • •The infants receiving treatment without any interventional process
  • •Those having a skin disease
  • •Those infants having peripherally inserted central venous catheter

研究组 & 干预措施

Water-based barrier tape

Experimental

The infants in experiment 1 group will be applied water-based barrier tape will be used to fix the nasogastric tube

干预措施: Water-based barrier tape (Device)

Hydrocolloid barrier tape

Experimental

The infants in experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube

干预措施: Hydrocolloid barrier tape (Device)

Silk plaster

Active Comparator

The silk plaster used in clinic routinely will be used for control group infants to fix the nasogastric tube

干预措施: Silk tape (Device)

结局指标

主要结局

Water-based barrier tape

时间窗: 24 hours

To evaluate pain felt by infants following the removal of silk adhesive from water-based barrier tape

Silk Tape

时间窗: 24 hours

To evaluate pain felt by infants following the removal of silk adhesive from infants skin without any barrier tape

Hydrocolloid barrier tape

时间窗: 24 hours

To evaluate pain felt by infants following the removal of silk adhesive from hydrocolloid barrier tape

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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