Effects of the Interventions Using Multiple Sensory Integrations on Relieving Pain and Distress in Preterm Infants During Peripheral Venous Puncture Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Preterm infants' pain
研究概览
简要总结
Frequent pain and distress may affect infants' brain and neural development, and highlight the need for relieve pain interventions. Peripheral venous puncture procedures are an important source of preterm infants' pain and distress. Brain development is mainly created by infant sensory experience. It becomes important, therefore, to relieve preterm infants' pain and distress using multiple sensory integrations during peripheral venous puncture procedures.The proposed 2-year study has specific aim: to compare the effects of different combination of sensory integrations on preterm infants' pain and distress before, during, and after peripheral venous puncture procedures.
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 (Participant)
入排标准
- 年龄范围
- 3 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age (GA) 28-37 weeks
- •Post-menstrual age (PMA) 29-38 weeks
- •Postnatal age 3-28 days
- •Sable condition (NTISSscore ≦ 22)
- •Apgar scores≧7 at 5 minutes after birth
排除标准
- •Neurologic impairment
- •Congenital anomalies
- •Severe growth restriction at birth
- •Severe medical conditions requiring treatments
结局指标
主要结局
Preterm infants' pain
时间窗: 20-30 minutes (during peripheral venous puncture procedures)
Premature Infant Pain Profile-Revised (PIPP-R) for pain, A score \<7 suggests no or little pain, 7-12 mild to moderate pain and scores \>12 indicate moderate to severe pain.
次要结局
- Preterm infants' physiological parameters: oxygen saturation(20-30 minutes (during peripheral venous puncture procedures))
- preterm infants' physiological parameters:heart rate(20-30 minutes (during peripheral venous puncture procedures))
- Preterm infants' physiological parameters:respiration rate(20-30 minutes (during peripheral venous puncture procedures))
- preterm infants' duration of fussing and cry(20-30 minutes (during peripheral venous puncture procedures))
- preterm infants' behavioral responses(20-30 minutes (during peripheral venous puncture procedures))
研究者
Hsiang-Ping Wu
Principal Investigator
National Defense Medical Center, Taiwan