Effectiveness of Reversed Kangaroo Mother Care Positioning on Level of Pain, Physiological Parameters among Preterm infants, and Mothers anxiety during the Screening of Retinopathy of Prematurity in selected tertiary care hospital-A Randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain level
研究概览
简要总结
The study proposal has been submitted to the university and is now registered under its records. It has also been reviewed and approved by the Institutional Ethics Committee, and a reference number has been issued. A data collection tool has been developed to gather participant information, which has been sent to experts for validation and reliability testing. A pretest will be conducted once the reliability of the tool is confirmed. The reverse Kangaroo Mother Care (KMC) intervention has been prepared and submitted to experts for validation. Based on the feedback received, minor modifications were made to the intervention as suggested by the experts. the sample will be enrolled based on the rendomizat5ion process. Following the completion of a pilot study, the main research will be conducted by enrolling mothers and their preterm infants to assess the pain levels and maternal satisfaction with the revised KMC procedures during the retinopathy of prematurity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Month(s) 至 8.00 Month(s)（—）
- 性别
- All
入选标准
- •Preterm birth with a gestational age less than and equal to 34 weeks Weight less than 2000g.
- •No prior history of fundus screening.
排除标准
- •Preterm babies with critical conditions such as severe respiratory distress, central nervous system infection, sepsis, etc.
- •Other diseases, such as congenital heart malformation, pulmonary insufficiency, etc.
- •Babies who received NSAID, sedative, or antiepileptic drugs within 24 hours before screening.
- •Mothers who are in ICU, mentally unstable, unconscious or who cannot hold and sit on KMC chair.
结局指标
主要结局
Pain level
时间窗: 3 times
次要结局
- neonates physiological Parameters maternal Stress satisfaction(one time)
研究者
Manisha Praharaj
Ms.