The Effect of Oral Breast Milk and 20% Dextrose Solution Administered With Supportive Positioning Methods on Pain and Physiological Variables During Heel Puncture Blood Sampling in Preterm Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Change in the mean score of neonatal pain, agitation and sedation scale
研究概览
简要总结
Pain, defined by the International Association for the Study of Pain as a subjective, sensory, and emotional experience, differs from nociception, which is merely a neural activity. Premature newborns, whose inhibitory fibers are not yet mature due to anatomical and physiological development and who have insufficient endogenous opioid release, experience painful stimuli much more intensely. The inability of this age group to verbally express pain makes the diagnosis, assessment, and management of pain entirely dependent on healthcare professionals. Pain that is not effectively managed leads to stress and loss of comfort in the short term, while in the long term it can cause permanent neurodevelopmental problems and alter the individual's pain threshold later in life.
Premature infants, especially those in Neonatal Intensive Care Units (NICUs), are exposed to invasive procedures that cause moderate to severe pain, such as heel prick tests, much more frequently than healthy term infants. In this context, pain management is a fundamental and essential nursing responsibility for the infant's neuroprotective developmental care. The literature shows that various non-pharmacological methods, such as oral sucrose, non-nutritive sucking (NNS), facilitated flexion, and wrapping, are used to alleviate pain during interventional procedures. Although more readily available in NICUs, studies on the effectiveness of oral glucose solutions are more limited compared to sucrose.
This research, designed to address this gap in the existing literature, aims to investigate the effect of "oral breast milk, 20%, and 10% dextrose solution administered with supportive positioning methods" on pain reduction during heel prick blood sampling in premature newborns. The results of this research are expected to contribute to the development of a new, easily applicable, effective, and evidence-based nursing intervention strategy for NICUs.
详细描述
Aim: This study aims to determine the primary effect of oral breast milk, 20% dextrose, and 10% dextrose solutions-administered alongside supportive positioning methods during routine heel lancing blood sampling (within the Neonatal Screening Program)-on pain scores in premature newborns admitted to the NICUs. Secondarily, it aims to evaluate the effects of these interventions on heart rate and oxygen saturation variables.
Hypotheses: The research hypothesizes that there is a statistically significant difference between the oral breast milk, 20% dextrose, and 10% dextrose solution groups (applied with supportive positioning) regarding pain scores (H1a), heart rate (H1b), and oxygen saturation levels (H1c) during the heel lancing procedure.
Study Design: The study will be conducted using a single-center, parallel-group, randomized controlled trial design.
Study Location: The research will take place in the Neonatal Intensive Care Unit of Mersin University Hospital.
NICUs Characteristics: The unit features a traditional open-bay design comprising two wards. It provides level 4a care and has a total incubator capacity of 27.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 32 Weeks 至 37 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parental consent for the baby's participation in the study
- •Admission to Mersin University Hospital NICU between July 16, 2026 and December 30, 2026,
- •Gestational age at birth between 33 weeks and 37 weeks,
- •Postnatal age less than 7 days,
- •Heel prick blood test planned within the scope of NTP,
- •Stable clinical condition,
- •Absence of genetic or metabolic problems,
- •Developed sucking-swallowing and breathing coordination,
- •Having been fed at least 30 minutes before the procedure,
- •No experience with invasive procedures in the last 6 hours before the procedure,
- •No administration of non-opioid analgesics in the last 4 hours before the procedure,
- •No administration of opioid analgesics and sedative agents in the last 24 hours before the procedure,
- •Spontaneous respiration at 21% FiO2,
- •Absence of neurological problems (e.g., asphyxia, hypoxic ischemic encephalopathy, intraventricular hemorrhage, periventricular leukomalacia, spinal cord injury…),
- •Absence of contraindications to oral glucose/breast milk administration (e.g., necrotizing enterocolitis or suspicion thereof, feeding intolerance, tracheoesophageal fistula, absence of esophageal atresia…),
- •Absence of endocrine problems (e.g., hypoglycemia, hyperglycemia, large for gestational age, absence of a diabetic mother…),
排除标准
- •Parental disapproval of infant's participation in the study
- •No hospitalization at Mersin University Hospital NICUs between July 16, 2026 and December 30, 2026,
- •Gestational age at birth less than 33 weeks or greater than 37 weeks,
- •Postnatal age greater than 7 days,
- •Heel prick blood test not planned within the scope of NTP,
- •Clinical condition not stable,
- •Lack of developed sucking-swallowing and breathing coordination,
- •Having been fed within 30 minutes of the procedure,
- •Having had invasive procedures experience in the last 6 hours before the procedure,
- •Having received non-opioid analgesics in the last 4 hours before the procedure,
- •Having received opioid analgesics and sedative agents in the last 24 hours before the procedure,
- •Genetic or metabolic problem The following are contraindications:
- •Being on invasive or non-invasive mechanical ventilation support,
- •Having a neurological problem,
- •Oral glucose/breast milk administration being contraindicated,
- •Having an endocrine and metabolic problem.
研究组 & 干预措施
breast milk group
supportive positioning techniques during routine heel prick blood sampling and oral breastfeeding.
干预措施: Administering oral breast milk in a supportive position (Behavioral)
10% dextrose solution group
Application of 10% dextrose solution with supportive positioning during routine heel prick blood sampling.
干预措施: Administering oral 10% dextrose in a supportive position (Behavioral)
20% dextrose solution group
Application of 20% dextrose solution with supportive positioning during routine heel prick blood sampling.
干预措施: Administering oral 20% dextrose in a supportive position (Behavioral)
结局指标
主要结局
Change in the mean score of neonatal pain, agitation and sedation scale
时间窗: During the procedure
The Neonatal Pain, Agitation, and Sedation Scale has a maximum score of 10, a minimum score of 0, and no lower limit. It is generally interpreted that "the higher the score on the scale, the more pain the baby is in."
次要结局
- The effect of orally administered breast milk, 10% and 20% dextrose solutions, along with supportive positioning techniques during heel prick blood sampling in premature infants, on heart rate.(During the procedure)
- The effect of supportive positioning techniques during heel prick blood sampling in premature infants, along with orally administered breast milk, 10% and 20% dextrose solutions, on respiratory rate.(During the procedure)
研究者
Ozlem Guzel Polat
PhD, Nursing, Principal Investigator
Mersin University