Clinical Trial

Effect of Paternal Touch on Sucking Performance, Comfort, and Glucose Levels in Newborns at Risk for Hypoglycemia

Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-12-11; most recent amendment 2026-03-10.
Status change: Not Yet Recruiting → Recruiting 2026-03-10
Trial Details
NCT Number NCT07302412
Lead Sponsor Acibadem University
Conditions Infant, Newborn
Enrollment 98 participants
Start Date 2026-01-05
Primary Completion 2027-12-08 (estimated)
Study Completion 2027-12-08 (estimated)
Updated on ClinicalTrials.gov 2026-03-11