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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorAcibadem University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Newborns who develop hypoglycemia during the study period or who require initiation of hypoglycemia treatment.

Newborns with congenital anomalies or a diagnosed genetic syndrome.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gentle Human Touch

    Procedure/Surgery

    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.

  • Standard Care Group

    Other intervention

    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.

Treatment groups

98 Participants
are divided into 2 treatment groups
Group A: Gentle Human Touch GroupExperimental treatment 1 intervention
Group B: Standard Care GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Sucking Performance

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.

Time frame
During the first breastfeeding session and at the 6th hour
2

Newborn Comfort Level

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.

Time frame
After routine newborn care (baseline) and at the 6th hour
3

Blood Glucose Level

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.

Time frame
At the 2nd hour and the 6th hour

Secondary outcomes

Other outcomes

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