The Effect of Breastfeedıng and Kangaroo Care Applıed Before Heel Blood Collectıon on Newborn Paın and Comfort: A Randomızed Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
This research will be conducted using a randomized controlled, double-blind experimental design to determine the effects of breastfeeding and kangaroo care on the pain and comfort of newborn babies before heel prick blood sampling. The study group will consist of newborn babies, and one of the observers administering the pain and comfort scores will be independent of the research participants, with the observer evaluating the babies without knowing which group they belong to.
Study Hypotheses H0a = Breastfeeding before heel prick test in newborns does not affect the baby's pain.
H1a = Breastfeeding before heel prick test in newborns reduces the baby's pain. H0b = Kangaroo care before heel prick test in newborns does not affect the baby's pain.
H1b = Kangaroo care before heel prick test in newborns reduces the baby's pain. H0c = Breastfeeding before heel prick test in newborns does not affect the baby's comfort level.
H1c = Breastfeeding before heel prick test in newborns increases the baby's comfort level.
H0d = Kangaroo care before heel prick test in newborns does not affect the baby's comfort level.
H1d = Kangaroo care before heel prick test in newborns increases the baby's comfort level.
The research is planned to be conducted at the Obstetrics and Gynecology Department of Sivas Cumhuriyet University Women's and Children's Hospital in Sivas city center between February 1, 2025 and March 1, 2026.
The study population will consist of newborns born by cesarean section and admitted to the Obstetrics and Gynecology ward of Sivas Cumhuriyet University Health Services Application and Research Hospital. The study sample will comprise newborns born by cesarean section and admitted to the Obstetrics and Gynecology ward of Sivas Cumhuriyet University Health Services Application and Research Hospital who meet the study criteria. The study (breastfeeding group, kangaroo care group) and control groups will consist of a total of 120 newborns.
The following instruments will be used to collect research data: Newborn and Parent Demographic Information Form, Neonatal Infant Pain Scale (NIPS), Neonatal Comfort Behavior Scale, informed consent form, and Blinded Evaluator NIPS form. The study will also utilize a pulse oximeter, a camera, and a stopwatch.
详细描述
Heel prick blood sampling is one of the invasive procedures frequently performed in divorces. Ensuring the proper continuation and survival of fractures that occur during this procedure is of great importance. Nurses have responsibilities regarding the identification of cooling and comfort components of equipment, the operation of appropriate interventions using this equipment, and the maintenance of basic comfort enhancement. While there are limited industrial studies on the combined use of breastfeeding and kangaroo care for pain relief, no studies have been found that evaluate pain and temperature together. There is a need for current reports on monitoring, prevention, and treatment related to pain control in preterm and term newborns monitored both in and out of hospitals. In this context, the aim of our study is to determine the duration of pain and temperature associated with breastfeeding and kangaroo care applied before heel prick blood sampling in newborns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The study group consisted of newborn babies, one of the observers who scored the pain and comfort was an independent person from the research, and the observer made the evaluation without knowing which group the babies belonged to.
入排标准
- 年龄范围
- 24 Hours 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parental consent must be obtained in accordance with the participant information and consent form
- •The baby must be term, between 37-42 weeks gestation
- •Birth weight must be 2500 grams or more
- •The mother must be present with the baby
- •The baby must be healthy (no physical, metabolic, or genetic diseases, no surgical procedures have been performed)
- •There must be no condition that prevents pain assessment (neuromotor developmental delay, etc.)
- •The baby must not have undergone any invasive procedures other than routine interventions
- •The baby must have been born by cesarean section
- •The mother must speak and understand Turkish fluently
排除标准
- •Pre-procedure NIPS score of 3 or higher
- •Lack of parental consent based on participant information and consent form
- •Newborn born before 37 weeks of gestation
- •Birth weight under 2500 grams
- •Unstable general condition
- •Vaginal delivery
- •Invasive procedures performed on the baby other than routine procedures
- •Failure to obtain heel prick blood on the first attempt
- •Mother not speaking Turkish
研究者
BÜŞRA SERTAKAN BAŞPINAR
student
Cumhuriyet University