Effect of Multisensory Stimulation on Pain During the Preterm Infant's Eye Examination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain level
研究概览
简要总结
This study aimed to evaluate the effects of multisensory stimulation on pain and physiological parameters resulting from ROP examination in preterm newborns.
It was planned as a randomized controlled trial. trying to reach 80 newborns in total. Multisensory stimulation will be applied to the intervention group during the examination. In the control group, routine care will be applied during the examination.
详细描述
Preterm retinopathy may develop due to intubation in preterm newborns. Therefore, this population undergoes eye examinations at regular intervals. This procedure is painful procedure for babies. Nurses can apply interventions to reduce this pain. In this study, it was planned to apply multisensory stimulation to reduce the pain of the newborn. A randomized controlled trial and routine care were planned in the control group. Neonatal pain will be assessed using the PIPP scale.
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 (Care Provider)
入排标准
- 年龄范围
- 32 Weeks 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the registry, premature neonates with a gestational age of ≤ 32 weeks or newborns with a birth weight of < 1500 g.
- •Newborns undergoing a first-time eye exam to screen for retinopathy of prematurity.
排除标准
- •Newborns who need CPR during the examination.
- •Newborns experience apnea during the examination.
结局指标
主要结局
Pain level
时间窗: first 30 minutes during procedure
Premature Infant Pain Profile (PIPP) to be used to assess newborn pain.
次要结局
- Heart rate(first 30 minutes during procedure)
- Oksigen saturation(first 30 minutes during procedure)
研究者
Halil Ibrahim Tasdemir
Principal Investigator
Akdeniz University