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