Validation of the Bernese Pain Scale for Neonates With Consideration for Contextual Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 4
- 主要终点
- Change in pain response across time
研究概览
简要总结
The aims of this validation study are the testing of the Bernese Pain Scale for Neonates' (BPSN) psychometric properties. The variability of pain reactions related to behavioral and physiological patterns across time will also be examined. Furthermore, the influence of contextual factors on the variability of pain reactions across gestational age groups will be explored. The results will be used for modifications of the BPSN to account for contextual factors in future clinical pain assessment in neonates.
详细描述
Preterm birth rates are rising worldwide, including in Europe. In 2014, Switzerland's rate of premature births reached 7.2%. Still, while significant progress in neonatal care has increased the long-term survival of preterm infants, other long-term outcomes remain problematic. As a result, affected infants commonly undergo exceedingly high numbers of painful procedures on a daily basis. For many, these treatment interventions take place at a crucial period in the development of the nociceptive and central nervous systems, i.e., at a developmental stage when repeated painful stimulus may induce both structural and functional reorganization of the nervous system and an altered pain response.
As infants are unable to communicate verbally, clinical pain assessment in neonates, particularly those delivered preterm, is highly challenging. Therefore, pain responses have to be observed according to physiological and behavioral indicators which might vary across preterm infants depending on their physiological and neurological development stages.
The Bernese Pain Scale for Neonates (BPSN) is a multidimensional pain assessment tool which is already widely used in clinical settings in the German speaking areas of Europe. Recent findings suggest that pain reaction is influenced by more than noxious stimulation alone: it is assumed that contextual factors, e.g., gestational age (GA) or gender, might also impact pain reactivity.
The aims of this validation study are:
- to undertake the psychometric testing of the BPSN regarding its concurrent validity with the Premature Infant Pain Profile-Revised (PIPP-R), construct validity, interrater and intrarater reliability, specificity and sensitivity;
- to examine the variability of pain reactions related to behavioural and physiological patterns across time;
- to assess the influence of contextual factors on the variability of pain reactions across GA groups; and
- to examine the relationship between behavioural and physiological indicators across time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 24 Weeks 至 41 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born between 24 0/7 and 36 6/7 weeks of gestation will be included if they are expected to undergo 5 routine heel capillary blood samples during the first 14 days of life; if they are ventilated or not ventilated; and if their parents give informed consent.
- •Term infants born between 37 0/7 and 42 0/7 weeks of gestation will be included if they are expected to have at least 2 routine heel capillary blood samples during the first days of life and if their parents give informed consent.
排除标准
- •Grade III oder IV intraventricular haemorrhaging
- •Severe life-threatening malformation or suffer from any condition involving partial or total loss of sensitivity
- •pHa < 7.15 (umbilical cord)
- •Surgery for any reason
- •Congenital malformation affecting brain circulation and cardiovascular system
结局指标
主要结局
Change in pain response across time
时间窗: 2-5 timepoints within the first 14 days of life
Change and variability of pain response across different time points will be measured with the BPSN
次要结局
- Influence of individual contextual factors on pain response across time(2-5 within the first 14 days of life)
- Psychometric testing of the BPSN(2-5 timepoints within the first 14 days of life)
研究者
Eva Cignacco
Prof. Dr.
Bern University of Applied Sciences