Comparison of The Effects of The Products Used In Nazogastric Tube Fixation on Skin Integrity In Babies: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 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 compare the effect of products, used in the fixation of nasogastric tube, on skin integrity of 4-6 weeks infants hospitalized at neonatal and infant units. The hypothesis of the study is "Water-based barrier tape is more effective to protect skin integrity 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 protecting skin deficiencies using 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 October 2020-2021. 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 pilot study was carried out with 15 participants from each of the groups and the effect size was calculated as d=0.672 regarding the assessment of skin condition scores and 108 participants in total should be included in the study as 36 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 desciption form" and "Neonatal Skin Condition Score Scale" is used. The scale is 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 PICC and SVK catheters and do not meet the required criteria
研究组 & 干预措施
Water-based barrier tape
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
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)
Adhesive product
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 the skin integrity of the infants following the removal of silk adhesive from water-based barrier tape
Hydrocolloid barrier tape
时间窗: 24 hours
To evaluate the skin integrity of the infants following the removal of silk adhesive from hydrocolloid barrier tape
Adhesive tape
时间窗: 24 hours
To evaluate the skin integrity of the infants following the removal of silk adhesive from infants skin without any barrier tape
次要结局
未报告次要终点
研究者
cagri covener ozcelik
Assoc.Prof
Marmara University
