Effectiveness of the Reverse-Kangaroo Mother Care position as a non-pharmacological method for reducing pain during retinopathy of prematurity screening in pre-term newborns in comparison to conventional position: A comparative study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Premature Infant Pain Profile during Retinopathy of Prematurity screening in pre-term newborns in the Reverse-Kangaroo Mother Care position.
研究概览
简要总结
The Study Design will be a double-arm, parallel-group, open-label, randomized controlled trial hence comparing the Premature Infant Pain Profile during Retinopathy of Prematurity screening in pre-term newborns in the Reverse-Kangaroo Mother Care (R-KMC) Position to the conventional position in reducing pain. It will also compare the physiological Parameters such as heart rate, respiratory rate and crying in this position to the conventional position in reducing pain.
It is a Hospital-based study to be conducted in NICU (Neonatal Intensive Care Unit) of Tertiary Care Teaching Institute (Maharaja Agrasen Medical College, Agroha).
The objectives are as follows:
Primary Objective: To compare the Premature Infant Pain Profile during Retinopathy of Prematurity screening in pre-term newborns in the Reverse-Kangaroo Mother Care (R-KMC) position to the conventional position in reducing pain.
Secondary Objective: To compare the physiological Parameters such as heart rate, respiratory rate and crying during Retinopathy of Prematurity screening in pre-term newborns in the Reverse-Kangaroo Mother Care (R-KMC) position to the conventional position in reducing pain.
The study will be conducted in 6 months duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 30.00 Day(s)（—）
- 性别
- All
入选标准
- •All the pre term infants undergoing Retinopathy of Prematurity (ROP) Screening Examination whose parents have given consent for the study.
排除标准
- •Pre-Term Infants will be excluded from the study if they need any respiratory support, inotropic support or are born with significant congenital disabilities.
结局指标
主要结局
Premature Infant Pain Profile during Retinopathy of Prematurity screening in pre-term newborns in the Reverse-Kangaroo Mother Care position.
时间窗: Baseline Just 1 minute before and 1 minute After the Procedure.
次要结局
- The physiological Parameters such as heart rate, respiratory rate & crying during Retinopathy of Prematurity screening in pre-term newborns in the Reverse-Kangaroo Mother Care (R-KMC) position.(Baseline 1 minute Before & 1 minute after the Procedure)
研究者
Dhruv Kumar
Maharaja Agrasen Medical College