Effectiveness of Interventional Non-Pharmacological Nursing Pain Management for Preterm Infants at Neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Premature Infant Pain Profile - Revised
研究概览
简要总结
A randomized controlled trial will be conducted to examine the effect of non-pharmacological nursing pain management strategies in alleviating pain among preterm infants. The study includes a simple random sample of 105 preterm infants with CGA 32- < 37 weeks were randomly assigned into five groups: routine care (n = 21), breast milk (n = 21), oral sucrose (n = 21), KMC (n = 21), nesting position (n = 21). PIPP-R will be used to subjectively assess the pain intensity after heel stick, and salivary cortisol measures will be used to objectively assess the pain intensity in NICU at Children Welfare Teaching Hospital/ Medical City Complex in Baghdad City.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Preterm infants and their mothers were masked from the nature of the administered intervention.
入排标准
- 年龄范围
- 32 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants whose corrected gestational age from (32 - <37) weeks of pregnancy,
- •Preterm infants who do not experience any painful procedure for last 24 hours.
- •Preterm infants who do not receive any sedation for last 24 hours, and clinically required heel stick.
排除标准
- •Full-term infants whose gestational age (GA) is >37 weeks
- •Preterm infants who extremely preterm (< 28 weeks); very preterm (28-< 32 weeks)
- •Preterm infants who are proven or suspected sepsis, major congenital malformations, heart defect, necrotizing enterocolitis (NEC), and neurodevelopmental disability.
- •Preterm infants who receive respiratory support {Mechanical Ventilation, Continuous Positive Airway Pressure (CPAP), or high-flow support}
- •Preterm infants who are indicated for surgery
- •Preterm infants who are contraindicated to oral sucrose
- •Preterm infants who had a condition that might influence their physiological and responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs.
结局指标
主要结局
Premature Infant Pain Profile - Revised
时间窗: Two months
Premature Infant Pain Profile - Revised measures pain intensity through infant indicators (heart rate, oxygen saturation, brow bulge, eye squeeze). Other indicators in the PIPP-R include gestational age and behavioral state.
次要结局
未报告次要终点
研究者
Hiba Abdulwahid Dawood
Principal Investigator
University of Baghdad