The Effect of Position in Post-op Newborns Hospitalized in Pediatric Cardio Vascular Surgery Intensive Care Unit on Gastric Residual Volume and Comfort Level
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Neonatal Comfort Behavior Scale (COMFORTneo):"change" will be assessed
研究概览
简要总结
The purpose of this randomized controlled trial is to determine the effect of different positions (supine, prone, right lateral and left lateral) in post-op term newborns staying in Pediatric Cardio Vascular Surgery (PCVS) Intensive Care Unit on gastric residual volume and comfort level.
详细描述
In the study, crossover design from experimental designs was preferred. Crossover design is an experimental design type in which two or more interventions are applied in a sequence to each case in the study group. In these studies, each group is its own control group. In this design type, all different interventions in the study are applied to the same case; thus, differences that may arise due to individual differences are prevented. Additionally, less number of cases is sufficient in order to obtain the same number of observation data compared to the other design examples. Due to these properties, randomized crossover design model was used in this study. The study will be conducted in PCVS Intensive Care Unit of a University Hospital in Turkey between October 2020 and August 2021.
In this study, sample size was calculated at the confidence interval of 95% using "G. Power-3.1.9.4" program. In a study the effect size used for determining the sample size in the study was found to be 0.54 based on the mean and standard deviation values of the study. By using this effect size, minimum sample size was found as 38 children in order for the gastric residue amount difference between positions to express statistically significance (p<0.05) with theoretical power of 0.95. By considering that there might be losses in the study, it is planned to include a total of 44 children in the study.
The order of the 4 positions to be given to the infants in the study group (A:Prone Position, B:Right lateral Position, C:Left lateral Position, D:Supine Position) was determined by lot method. 4 different orders were chosen randomly from all possible orders of 4 positions to be given to the infants in the study group (24 different orders). Each different order of the positions was expressed as a group. 4 orders randomly selected from 24 different orders were as follows:
The order in the first group is A, C, D, and B; The order in the second group is D, A, B, and C; The order in the third group is C, B, A, and D; The order in the fourth group is B, D, C, and A.
Groups and position orders according to the result of the draw:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Having a gestational week of 37 and above,
- •Undergoing heart surgery,
- •Being separated from the mechanical ventilator,
- •Starting to be fed with nasogastric or orogastric tube,
- •Not showing any signs of infection,
- •Not using narcotic drugs in post-op period,
- •Having no factors that can interfere with feeding (vomiting, distention, necrotizing enterocolitis, etc.)
- •Having no condition that can prevent positioning,
- •Receiving Informed Consent Form from their families.
排除标准
- •• Having a gestational week of less than 36+6 days,
- •Have not been separated from the mechanical ventilator,
- •Showing any signs of infection,
- •Using narcotic drugs in the post-op period,
- •Having factors that may prevent feeding (vomiting, distention, necrotizing enterocolitis, etc.)
- •Having a condition that can prevent positioning,
- •Receiving no consent from their mother or father.
结局指标
主要结局
Neonatal Comfort Behavior Scale (COMFORTneo):"change" will be assessed
时间窗: The Newborn Comfort Behavior Scale will be evaluated at the 30 to 120 minutes after the position.
This scale is a Likert type scale developed to be used in the evaluation of sedation and comfort needs, pain and distress of newborns followed-up in intensive care. COMFORTneo is composed of six parameters including alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tone. Each item in the scale is scored from 1 to 5. It is evaluated over the total score. The lowest score of COMFORTneo is 6 and the highest score is 30. If total score of the scale is between 9-13 points, it refers that the infant is "comfortable". If it is between 14-30 points, it is emphasized that the infant has "pain or distress", is uncomfortable and requires interventions that will provide comfort.
Residue Follow-up Form: "change" will be assessed
时间窗: It will be checked at 30 to 120 minutes after feeding.
The form prepared to follow up the residue includes the position given, amount of nutrition, the way of feeding, feeding type, and residue amount control.
Vital Signs Follow-up Form: "change" will be assessed
时间窗: It will be evaluated at 30 to 120 minutes after positioning.
This form prepared by the researcher in line with the literature was composed of the parameters of heart rate (min), respiratory rate (min) and oxygen saturation value (%SpO2) of the newborn.
次要结局
- Heart Rate (min): "change" will be assessed(It will be evaluated at 30 to 120 minutes after positioning.)
- Oxygen Saturation (%SpO2): "change" will be assessed(It will be evaluated at 30 to 120 minutes after positioning.)
- Respiration Rate (min): "change" will be assessed(It will be evaluated at 30 to 120 minutes after positioning.)
研究者
Fatma Yılmaz Kurt
Asist Prof Dr
Çanakkale Onsekiz Mart University