Comparative Analysis of a Behavioral Level, Skin Conductance and Heart Rate Variability in Assessing the Pain in Preterm Newborn
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Correlation between HFVI index and PIPP-R pain score .
研究概览
简要总结
The purpose of this study is to correlate the composite PIPP-R (Premature Infant Pain Profile-Revised) scale and the parasympathetic nervous system (heart rate variability).
详细描述
The premature newborns hospitalized for several weeks are exposed to a significant number of nursing procedures or painful or stressful medical. Repeated pain in the neonatal period may have negative consequences in the short and / or long term. The diagnosis of pain remains difficult because based on the hetero-assessment involving the use of validated scales. The PIPP-R scale (Premature Infant Pain Profile-Revised) appears to be the most complete and best validated scale as composite (behavior items, vegetative and contextual). However, it is rarely used in routine care in France.
Alternatives to clinical scoring the pain level were described, in particular the analysis of the variability of the heart rate [VHR] by HFVI index (High Frequency Variability Index) or skin conductance. The analysis of the spectral components of high frequencies or HFVI would be an indicator of parasympathetic activity. The HFVI was compared to the EDIN scale, purely behavioral level, proposed as chronic pain marker. Skin conductance would be a stress marker reflecting variations of the sympathetic system.
These techniques are currently marketed for routine use. However, these methods have been compared and the NIPE (Newborn Infant parasympathetic Evaluation), which assesses the HFVI index, was not compared to a validated scale procedural acute pain (such as PIPP-R).
It seems important, before disseminating these methods, explore the consistency of these techniques with each other and validated scales, and their acceptability by nurses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns with gestational age less than 36 weeks
- •Hospitalization in neonatology unit or intensive care unit
- •Signature of major parental consent for participation of their child
排除标准
- •Brain injury (intraventricular haemorrhage> Grade 2 or peri- ventricular leukomalacia extended)
- •Administration of anticholinergic or adrenergic antagonist in the previous 48 hours
- •Administration of curares
- •Genetic abnormality or severe malformation
结局指标
主要结局
Correlation between HFVI index and PIPP-R pain score .
时间窗: 12 months plus the total duration of the patient's hospitalization
In case of repeated measurements on the same child, only the first couple of steps will be considered for this correlation calculation.
次要结局
- Correlation of cutaneous conductance, HFVI and PIPP-R according to the sex of the child(12 months plus the total duration of the patient's hospitalization)
- Correlation of cutaneous conductance, HFVI and PIPP-R according to the gestational age group type(12 months plus the total duration of the patient's hospitalization)
- Correlation between skin conductance and pain score PIPP-R.(12 months plus the total duration of the patient's hospitalization)
- Correlation between skin conductance, HFVI and PIPP-R according to the type of painful procedure: painful or not(12 months plus the total duration of the patient's hospitalization)
- Caregiver satisfaction with each technique via the likert scale.(12 months plus the total duration of the patient's hospitalization)