Pain Responses in Preterm Infants and Parental Stress Over Repeated Painful Procedures: a Randomized Pilot Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of questionnaire completion
研究概览
简要总结
This pilot study was conceptualised to determine the feasibility of involving parents via facilitated tucking or observing during painful procedures and to measure change in parental stress and infant pain. An additional purpose of this pilot study was to determine the size of the cohort of preterm infants needed for a larger trial, the time, and resources required for recruitment and data collection.
详细描述
Objectives
In this pilot study, the aims were to determine the feasibility of whether pain behaviour in extremely and very preterm infants and perceived parental stress change when parents are involved in pain reducing measures, either actively, performing facilitated tucking or passively, observing the intervention, in comparison to the involvement of nurses only. In addition, the infant's pain reactivity and parental stress over three time points of measurement was of interest.
Methods
Extremely and very preterm infants in need of subcutaneous erythropoietin were randomly assigned to the two intervention groups. The intervention encompassed that one parent of each infant was involved during the painful procedure: Either parents executed facilitated tucking themselves or stood by, observing the procedure. Usual care involved that nurse executed facilitated tucking. All infants received 0.5ml of 30% oral glucose solution via cotton swab before the painful procedure. Infant pain was observed with the Bernese Pain Scale for Neonates (BPSN) and measured with the skin conductance algesimeter (SCA) before, during, and after the procedure. Parents' stress levels were measured before and after the painful procedure on the infant, using the Current Strain Short Questionnaire (CSSQ).
Feasibility of a subsequent trial was determined by assessing recruitment, measurement and active parental involvement. Quantitative data collection methods (i.e., questionnaires, algesimeter) were employed to determine the number of participants for a larger trial and measurement adequacy. Qualitative data (interviews) was employed to determine parents' perspectives of their involvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The six NICU nurses involved were blinded to the purpose of the study, whereas the clinical nurse specialist (CNS) was not. Always three members of this research team conducted the pain assessment during the facilitated tucking or the observing by the parents. The other three members of the research team focused on the nurses' group.
The CNS or the neonatologist provided information about the study to the parents, without stating its specific aim, instead referring in principle to the increased involvement of parents in pain management.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants born at the NICU concerned
- •Born between 24 0/7- 32 0/7 weeks of gestation, birthweight (bw) <1250g
- •Infant in need of s.c. erythropoietin
- •Parents fluently speaking and writing in German
- •Written informed consent by parents
排除标准
- •Premature infant with an umbilical artery pH measurement <7.00 or asphyxia
- •Premature infant with life threatening malformations of the central nervous system
- •Premature infant with intracranial haemorrhage (even if not present at the start of the study)
- •Premature infant with any surgical intervention
- •Parents with substance abuse (i.e., methadone, heroin, etc.), as mentioned in the electronic patient documentation (EPD)
结局指标
主要结局
Percentage of questionnaire completion
时间窗: 1 year
* Check percentage of questionnaires completed and withdrawals * Interview parents about the feasibility of participating three times
The active parental involvement over three time points were reviewed for feasibility
时间窗: 1 year
In semi-structured interviews, parents were asked about performing facilitated tucking or standing by as observers, acceptance, applicability and feasibility of the CSSQ and measurement over three time-points -The research team was also interviewed about active parental involvement
The main objective of this pilot study was to determine the feasibility of a larger, appropriately powered study
时间窗: 1 year
Feasibility assessment included recruitment rate (dependent on resources and in-/exclusion criteria)
The pain and stress measurement over three time points were reviewed for feasibility
时间窗: 1 year
-The research team was also interviewed about acceptance, applicability and feasibility of the validated BPSN, the SCA over three time points
次要结局
- The secondary interest of the study was to test for significant differences in parental stress between the two intervention and control group at three measurement points as well as infant pain.(1 year)