Postoperative Pain Assessment in Newborns Using Skin Conductance Measurement
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Skin conductance correlation to N-PASS
研究概览
简要总结
This observational study aims to evaluate skin conductance monitoring as a continuous method for pain assessment in postoperative neonates. Pain assessment in newborns is challenging due to their inability to communicate, and current methods rely on intermittent observational scales such as the Neonatal Pain, Agitation and Sedation Scale (N-PASS) in combination with physiological parameters.
Skin conductance reflects sympathetic nervous system activity and provides a continuous, objective measure of stress and pain. This study will investigate the correlation between skin conductance measurements and standard clinical pain assessment tools (N-PASS and vital parameters), as well as explore the potential analgesic effect of skin-to-skin care.
The study is conducted in a neonatal intensive care unit (NICU) setting where all monitoring and treatments are part of routine clinical care.
详细描述
Exposure to pain in the neonatal period is associated with adverse short- and long-term outcomes, including altered neurodevelopment. Accurate pain assessment is therefore essential but remains challenging due to the lack of a gold standard.
Currently, pain assessment in neonates relies on observational tools such as N-PASS, which incorporates behavioral and physiological indicators. However, these assessments are intermittent and subject to observer variability.
Skin conductance monitoring is an objective and continuous method that measures sympathetic nervous system activity through electrodermal responses. Previous research has demonstrated that skin conductance can detect stress and pain responses even in extremely preterm infants.
In this study, postoperative neonates admitted to the NICU will be continuously monitored using skin conductance for approximately 72-80 hours following surgery. Routine clinical pain assessments using N-PASS will be performed at regular intervals, alongside continuous monitoring of vital parameters.
Additional clinical data will be collected from electronic medical records, including demographic characteristics, perinatal history, surgical details, postoperative recovery parameters, and analgesic treatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates admitted to the NICU
- •Undergoing surgical intervention
- •Receiving postoperative care at the study site
排除标准
- •Major heart surgery
- •No parental consent
结局指标
主要结局
Skin conductance correlation to N-PASS
时间窗: 72-80 hours post surgery
The correlation between pain assessment using skin conductance monitoring compared to pain assessment using the visual pain assessment scale N-PASS in combination with changes in vital parameters
次要结局
未报告次要终点