The Effect of Breast Milk and Knitted Octopus on the Pain Caused by Orogastric Tube Insertion in Preterm Newborns
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Premature Infant Pain Profile (PIPP)
研究概览
简要总结
Aim : This study will be conducted to determine the effect of breast milk and knitted octopus in reducing pain caused by routine orogastric tube insertion in preterm newborns.
Method : This study was planned as a randomized controlled trial. The study group will consist of 66 preterms with a gestational age of 32-34 weeks fed by orogastric tube. Informed Consent Form, Preterm Newborn Introduction Form, Physiologic Parameters Measurement Form and Premature Infant Pain Profile (PIPP) will be used in the study. The research will be conducted in the Neonatal Intensive Care Unit of a university hospital in Denizli province. Newborns in the breast milk group will be given oral breast milk before the procedure. Newborns in the knitted octopus group will be provided with the octopus touching various parts of their bodies as a tactile stimulation before the procedure. No intervention will be performed on newborns in the control group. Data will be obtained by the researcher from camera recording and patient file. In evaluating the data, continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Parametric and non-parametric tests will be used to examine the differences between groups.
Hypothesis: It is expected to contribute to the development of a new approach in the pain management of preterm newborns by evaluating the effectiveness of breast milk and knitted octopus in reducing the pain caused by orogastric tube insertion in preterm newborns.
详细描述
İNTRODUCTİON Preterm babies experience many problems in the postnatal period because they are anatomically and physiologically immature.Nutritional problems have an important place among these problems.In the first days of life, they are fed enterally via orogastric tube. Enteral nutrition is the process of giving the newborn's nutrition through a nasogastric (NG), orogastric (OG) or transpyloric tube.Baby feeding tube insertion causes pain.Although in the past years it was said that the newborn did not feel pain, the prenatal starts to feel it from the 20th week. When pain is not detected, the growth and development of the newborn is negatively affected.There are pharmacological and non-pharmacological methods in pain management.
Touch is considered the most basic communication and is well developed. Breast milk increases immunity and ensures growth and development.The sense of taste is highly developed even in premature babies.
There is no study in the literature comparing breast milk and the knitting octopus method together.Considering that orogastric tube application in newborns is a common clinical practice, it is important to minimize the side effects of this treatment method and increase the comfort of babies.
Aim of the study: This study will be conducted to determine the effect of breast milk and knitted octopus in reducing pain caused by routine orogastric tube insertion in preterm neonates.
Materials and Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Single blinding (participants) will be used in the study. Participants will not be informed about which group they are in.
入排标准
- 年龄范围
- 32 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational week between 32-34 weeks
- •Postnatal age ≤ 37 weeks
- •Having breast milk
- •Weighing 1000 grams or more
- •Spontaneous breathing
- •Being fed with an orogastric tube
- •Not being exposed to a painful procedure at least half an hour before the interventions
- •Parental consent for the newborn to participate in the study
排除标准
- •Having received ventilator support (may have received it before)
- •Any congenital anomaly of the face or oral cavity
- •Grade 3 and 4 intraventricular hemorrhage
- •Taking opioid or non-opioid analgesics
- •Repeated orogastric tube placement
结局指标
主要结局
Premature Infant Pain Profile (PIPP)
时间窗: one year
In order to evaluate the baby's pain, the PIPP scale questions 7 items such as gestational age, behavioral status, highest heart rate value, lowest oxygen saturation value, forehead wrinkling, squinting of the eyes and widening of the nose wings. Each item; It is scored as 0, 1, 2 and 3, from best to worst. According to the Premature Baby Pain Profile, the baby's pain is evaluated based on the total score. Accordingly, the highest is 21 points and the lowest is 0 points. If the Premature Baby Pain Profile is between 0 and 6 points, the pain is considered mild, between 7 and 12 points, it is considered moderate, and between 13 and 21 points, the pain is considered severe.
次要结局
未报告次要终点
研究者
Melek Nur Guzel
researcher
Pamukkale University