The Effect of Paternal Touch on Sucking Performance, Comfort, and Glucose Levels in Newborns at Risk for Hypoglycemia During the First Hours of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Sucking Performance
研究概览
简要总结
This randomized controlled trial aims to examine the effects of Gentle Human Touch applied by fathers during the first hours of life on sucking performance, comfort level, and blood glucose values in newborns at risk for hypoglycemia. Eligible newborns will be randomly assigned to intervention and control groups.
After the newborn is taken to the baby care room and routine care procedures are completed, comfort level will be assessed by the primary nurse and an independent second observer using the Neonatal Comfort and Behavior Scale (NCBS). In the intervention group, the first Gentle Human Touch application will begin after routine care and the initial comfort assessment are completed. Sucking performance will be assessed during the first breastfeeding session by the primary nurse and an independent observer using the LATCH Breastfeeding Assessment Tool.
In the intervention group, fathers will administer 15-minute Gentle Human Touch sessions every hour for six hours according to a structured protocol. In the control group, routine care will be provided without any additional touch.
In both the intervention and control groups, blood glucose levels will be measured at the 2nd hour according to clinical protocols. At the 6th hour, the newborn's comfort level (NCBS), sucking performance (LATCH), and blood glucose level will be reassessed and recorded.
This study aims to determine whether early paternal touch supports glucose stability, improves sucking performance, and enhances comfort in newborns at risk for hypoglycemia, and to contribute to the development of family-centered, non-invasive care practices in neonatal settings.
详细描述
Neonatal hypoglycemia is one of the most common metabolic problems in the neonatal period and is particularly prevalent among infants with specific perinatal risk factors. Approximately one-third of newborns are considered at risk for hypoglycemia, and a substantial proportion develop low blood glucose values within the first 24-48 hours of life. Because failure to promptly recognize and treat hypoglycemia may lead to neurological injury, implementing interventions that support physiological stability during the first hours of life is critically important in at-risk newborns. Early skin-to-skin contact and initiation of breastfeeding contribute to the maintenance of glucose regulation and physiological stability; however, research examining the effects of structured paternal touch (Gentle Human Touch) in newborns at risk for hypoglycemia is extremely limited.
Gentle Human Touch (GHT) is a non-invasive intervention applied by healthcare professionals or parents, consisting of steady, warm, light hand placement on specific areas of the infant's body. Studies conducted in preterm and term infants have reported that GHT may reduce stress responses, support behavioral organization, and positively affect physiological parameters such as heart rate and oxygen saturation. Nevertheless, no studies have specifically examined the impact of paternal gentle touch on feeding performance, comfort, and glucose regulation in newborns. This research will be one of the first to evaluate whether paternal GHT improves early physiological and behavioral outcomes in newborns at risk for hypoglycemia.
The primary aim of this study is to determine the effects of paternal Gentle Human Touch applied during the first hours of life on sucking performance, comfort level, and blood glucose values in newborns. The null hypothesis states that paternal GHT has no effect on these outcomes, whereas the alternative hypothesis proposes that the intervention will improve sucking performance, increase comfort, and support glucose stability.
This single-center, randomized controlled experimental study will be conducted in the baby care room of Acibadem Mehmet Ali Aydinlar University Atakent Hospital. The study population consists of all newborns followed in the baby care room who are identified as being at risk for hypoglycemia. The sample will include newborns who meet the inclusion criteria and whose parents provide written informed consent. Based on a power analysis conducted using G*Power, with an effect size of 0.57, a 95% confidence level, and 80% power, a minimum of 49 newborns per group is required, resulting in a total sample size of 98.
Risk for hypoglycemia will be evaluated based on clinical factors including maternal diabetes, preeclampsia, pregnancy-induced hypertension, use of beta-blockers or other medications associated with neonatal hypoglycemia, prematurity, SGA/LGA status, intrauterine growth restriction, asphyxia, hypoxia, sepsis, polycythemia, hypothermia, metabolic or endocrine disorders, antepartum glucose administration, intravenous indomethacin use, and similar risk conditions. Newborns with major congenital anomalies or genetic syndromes, as well as those who develop hypoglycemia requiring treatment during the study period, will be excluded.
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
- None
盲法说明
Two independent assessors evaluate newborn feeding performance (LATCH) and comfort (COMFORTneo). The secondary assessor is blinded to group allocation and does not participate in the intervention. Both assessors perform evaluations independently and are blinded to each other's measurements to minimize observer bias."
入排标准
- 年龄范围
- 1 Hour 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborns identified as being at risk for hypoglycemia (see study population).
- •Newborns whose parents/legal guardians have provided written informed consent.
- •Clinically stable newborns who have no contraindications to breastfeeding during the first 6 hours after birth.
- •Newborns whose fathers are present during the first 6 hours after birth.
排除标准
- •Newborns who develop hypoglycemia during the study period or who require initiation of hypoglycemia treatment.
- •Newborns with congenital anomalies or a diagnosed genetic syndrome.
研究组 & 干预措施
Gentle Human Touch Group
The father will apply Gentle Human Touch (GHT) following a structured protocol. After the newborn's routine care and baseline comfort assessment are completed in the baby care room, the first GHT session will begin. The father will place warm, steady hands on the newborn's head and pelvis, providing gentle, still touch for 15 minutes. This intervention will be repeated once every hour for the first 6 hours of life (a total of 6 sessions). No other additional interventions will be applied. Feeding performance, comfort level, and blood glucose values will be assessed according to the study protocol.
干预措施: Gentle Human Touch (Procedure)
Standard Care Group
Newborns in this group will receive routine clinical care only. No Gentle Human Touch or any other additional intervention will be applied. Baseline comfort assessment will be performed after routine care, and feeding performance, comfort level, and blood glucose values will be evaluated at the same time points as in the intervention group.
干预措施: Standard Care Group (Other)
结局指标
主要结局
Sucking Performance
时间窗: During the first breastfeeding session and at the 6th hour
Sucking performance will be assessed using the LATCH Breastfeeding Assessment Tool, which evaluates latch, audible swallowing, type of nipple, maternal comfort, and positioning. The total score ranges from 0 to 10, with higher scores indicating greater breastfeeding success, reflecting more effective sucking and better coordination. Assessments will be performed independently by the primary nurse and an independent second observer, who are blinded to each other's evaluations.
Newborn Comfort Level
时间窗: After routine newborn care (baseline) and at the 6th hour
Newborn comfort level will be assessed using the Newborn Comfort and Behavior Scale (COMFORTneo), which evaluates behavioral and physiological indicators of comfort. The total score ranges from 6 to 30, with higher scores indicating lower comfort and increased behavioral or physiological distress. After the newborn is taken to the baby care room and routine care is completed, assessments will be performed independently by the primary nurse and an independent second observer, who are blinded to each other's evaluations. A second assessment will be performed at the 6th hour.
Blood Glucose Level
时间窗: At the 2nd hour and the 6th hour
Blood glucose level will be measured using a standard glucometer according to routine clinical practice. The first measurement will be recorded at the 2nd hour, and the second measurement at the 6th hour. Importantly, blood glucose monitoring at these time points is part of the institution's routine protocol; therefore, no additional measurements are performed for research purposes.
次要结局
未报告次要终点
研究者
Semra Küçük
Lecturer
Acibadem University