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

NCT07302412 | Recruiting

• 1 other identifier: ATADEK-2025/18
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Newborn

Keywords

Gentle Human Touch; Paternal Touch; Newborn Feeding Performance; Comfort; Infant,; Blood Glucose; Newborn

Outcome Measures

Primary Outcomes (3)

• 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.

  During the first breastfeeding session and at the 6th hour

• 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.

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

• 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.

  At the 2nd hour and the 6th hour

Study Arms (2)

Gentle Human Touch Group

EXPERIMENTAL

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.

Procedure: Gentle Human Touch

Standard Care Group

OTHER

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.

Other: Standard Care Group

Interventions

Gentle Human Touch PROCEDURE

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.

Gentle Human Touch Group

Standard Care Group OTHER

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.

Standard Care Group

Eligibility Criteria

• Age: 1 Hour - 6 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Newborns who develop hypoglycemia during the study period or who require initiation of hypoglycemia treatment.
• Newborns with congenital anomalies or a diagnosed genetic syndrome.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem University Atakent Hospital

Istanbul, Istanbul, 34260, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Belpinar A, Yayan EH. Effect of Yakson touch and mother's voice on pain and comfort level during nasal CPAP application in Turkey: A randomized controlled study. Explore (NY). 2023 Sep-Oct;19(5):743-748. doi: 10.1016/j.explore.2023.02.010. Epub 2023 Feb 20.

  PMID: 36872192 BACKGROUND

• Cobo MM, Moultrie F, Hauck AGV, Crankshaw D, Monk V, Hartley C, Evans Fry R, Robinson S, van der Vaart M, Baxter L, Adams E, Poorun R, Bhatt A, Slater R. Multicentre, randomised controlled trial to investigate the effects of parental touch on relieving acute procedural pain in neonates (Petal). BMJ Open. 2022 Jul 19;12(7):e061841. doi: 10.1136/bmjopen-2022-061841.

  PMID: 36250332 BACKGROUND

• Kilinc D, Caglar S. The Effect of Mother's Gentle Human Touch on Preterm Neonate's Pain and Maternal Anxiety During Venipuncture in Turkiye. Res Nurs Health. 2025 Aug;48(4):487-496. doi: 10.1002/nur.22472. Epub 2025 May 20.

  PMID: 40392177 BACKGROUND

• Sezer Efe Y, Erdem E, Caner N, Gunes T. The effect of gentle human touch on pain, comfort and physiological parameters in preterm infants during heel lancing. Complement Ther Clin Pract. 2022 Aug;48:101622. doi: 10.1016/j.ctcp.2022.101622. Epub 2022 Jun 22.

  PMID: 35759976 BACKGROUND

Central Study Contacts

semra Kucuk, lecturer

CONTACT

05304154860; semra.kucuk@acibadem.edu.tr

Zehra Kan Öntürk, Associate professor

CONTACT

zehra.kan@acibadem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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."
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This study uses a parallel assignment randomized controlled design. Eligible newborns are randomly allocated to either the intervention group, in which paternal Gentle Human Touch is applied hourly for 15 minutes over the first 6 postnatal hours, or the control group, which receives routine care only. Randomization is performed using block randomization to ensure balanced allocation. Both groups are assessed in parallel at baseline, during the first breastfeeding session, and at the 2nd and 6th hours for feeding performance (LATCH), comfort level (COMFORTneo), and blood glucose values. No crossover between groups occurs.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 8, 2027
• Study Completion (Estimated): December 8, 2027
• Last Updated: March 11, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)