Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT07302412
Brief Summary:
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.
Detailed Description:
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.
Randomization will be performed using a block randomization method with blocks of four, ensuring balanced allocation between the intervention and control groups throughout data collection. Newborns will be assigned sequentially according to the pre-generated randomization list.
Data will be collected using three main instruments: (1) the Neonatal Information Form, which records antenatal, birth, and postnatal characteristics; (2) the LATCH Breastfeeding Assessment Tool, which evaluates feeding performance across five domains; and (3) the Neonatal Comfort and Behavior Scale (NCBS/COMFORTneo), which assesses behavioral and physiological comfort. Permissions for scale use have been obtained.
After birth, the newborn is transferred to the baby care room, where routine assessments (physical examination, respiratory evaluation, temperature regulation) are completed. Once these procedures are finished, the newborn's baseline comfort level will be assessed by the primary nurse and an independent observer using the NCBS. In the intervention group, the first Gentle Human Touch session will begin immediately after this initial comfort assessment. Fathers will receive verbal instruction and illustrated training materials explaining the protocol (hand placement, pressure, duration) before the first session.
According to the GHT protocol, the father washes his hands and warms them to approximately 34°C. In a quiet, low-stimulus environment, he places one hand gently on the infant's head and the other on the pelvic region, maintaining steady touch without stroking for 15 minutes. This procedure will be repeated once every hour for the first six hours after birth, totaling six sessions. In the control group, newborns will receive routine care without any additional touch.
When the mother is clinically stable, the newborn will be brought for the first breastfeeding session. During this feeding, sucking performance will be evaluated by the primary nurse and the independent observer using the LATCH scale. Blood glucose levels will be measured at the 2nd hour of life in accordance with routine clinical protocols for at-risk infants.
At the 6th hour, after the final GHT session in the intervention group, the newborn's comfort level (NCBS), sucking performance (LATCH), and blood glucose value will be reassessed and recorded in both groups.
Ethical approval has been obtained from the Acibadem Mehmet Ali Aydinlar University Medical Research Evaluation Board (ATADEK). Written informed consent will be obtained from parents before participation. The intervention is entirely non-invasive and consists only of gentle, steady paternal touch; therefore, it poses minimal risk. Blood glucose measurements are part of routine clinical care and no additional sampling will be performed for research purposes. Any infant who develops hypoglycemia requiring treatment will be managed per institutional protocol and removed from the study.
The findings of this study are expected to contribute valuable evidence regarding the role of paternal touch in promoting physiological and behavioral stability in newborns at risk for hypoglycemia and to support the integration of low-cost, family-centered, non-invasive interventions into routine neonatal care practices.
Study:
NCT07302412
Study Brief:
Protocol Section:
NCT07302412