The Effect of Paternal Skin-to-Skin Contact on Neonatal Parameters

NCT06956859 | Completed DMC

• 1 other identifier: SaglikBilimleri
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to examine the effect of skin-to-skin contact between the babies of mothers who gave birth by cesarean section and their fathers on the physiological parameters and comfort of the newborn. The research, which is in a randomized controlled experimental design, will be carried out at the Ministry of Health Sakarya University Training and Research Hospital. The spouses and babies of 80 pregnant women who were hospitalized with a planned cesarean delivery in Sakarya Training and Research Hospital Gynecology and Child Additional Service Building, will be divided into intervention and control groups by simple randomization method. Paternal skin-to-skin contact will be applied to newborns in the intervention group for 45 minutes. Routine care will be applied to the newborns in the control group. Father Descriptive Information Form, Newborn Descriptive Information Form, Skin-to-Skin Contact Monitoring Form (Newborn/Father), Newborn Comfort Behavior Scale will be applied to the cases included in the study, body temperature, oxygen saturation, heart rate, respiration will be evaluated, and salivary cortisol analysis will be performed. The discussion and results of the study will be written in the accompaniment of the findings.

Conditions

Skin to Skin Contact; Newborn; Vitality

Keywords

Skin to skin contact; cortisol; Comfort; newborn; paternalty

Outcome Measures

Primary Outcomes (3)

• newborn salivary cortisol level

  measurement of cortisol in saliva via the cotizol kit

  0th minute,20th minute,45th minute

• newborn oxygen saturation

  measurement newborn saturation via pulseoxymeter

  0th minute,20th minute,45th minute

• newborn body temperature

  measurement newborn body temperature by thermometer

  0th minute,20th minute,45th minute

Study Arms (2)

Skin to skin

EXPERIMENTAL

Paternal skin to skin applied to newborns.

Behavioral: Paternal Skin to skin applicated to newborns

Control Group

NO INTERVENTION

Routine maintenance practices were performed in the control group.

Interventions

Paternal Skin to skin applicated to newborns BEHAVIORAL

Paternal Skin to skin applicated to newbornsin the intervention group for 45 minutes. Routine care will be applied to the newborns in the control group. Father Descriptive Information Form, Newborn Descriptive Information Form, Skin-to-Skin Contact Monitoring Form (Newborn/Father), Newborn Comfort

Skin to skin

Eligibility Criteria

• Age: 5 Minutes - 15 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Being born at term (38-42 weeks of gestation)
• Birth weight between 2500-4000gr
• st and 5th minute apgar score of 7 and above
• The newborn does not have any health problems
• No surgical intervention
• No communication problems,
• At least primary school graduate,
• over 18 years old,

You may not qualify if:

• Congenital anomalies
• Metabolic diseases
• Severe periventricular/intraventricular bleeding
• History of minor or major surgery
• Babies from single-parent families
• Babies with intubation and mechanical ventilation
• Having a birth weight of less than 2500 g and more than 4000 g.
• Unwillingness to participate in the study
• Any contagious disease that can be transmitted through skin contact
• Experiencing fatherhood for the first time
• Not having any contagious disease that can be transmitted through skin contact

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Sakarya Training and Research Hospital

Adapazarı, Sakarya, Turkey (Türkiye)

Location

Related Publications (4)

• Morelius E, Theodorsson E, Nelson N. Salivary cortisol and mood and pain profiles during skin-to-skin care for an unselected group of mothers and infants in neonatal intensive care. Pediatrics. 2005 Nov;116(5):1105-13. doi: 10.1542/peds.2004-2440.

  PMID: 16263996 BACKGROUND

• Davis EP, Sandman CA. The timing of prenatal exposure to maternal cortisol and psychosocial stress is associated with human infant cognitive development. Child Dev. 2010 Jan-Feb;81(1):131-48. doi: 10.1111/j.1467-8624.2009.01385.x.

  PMID: 20331658 RESULT

• Shonkoff JP, Garner AS; Committee on Psychosocial Aspects of Child and Family Health; Committee on Early Childhood, Adoption, and Dependent Care; Section on Developmental and Behavioral Pediatrics. The lifelong effects of early childhood adversity and toxic stress. Pediatrics. 2012 Jan;129(1):e232-46. doi: 10.1542/peds.2011-2663. Epub 2011 Dec 26.

  PMID: 22201156 RESULT

• Takahashi Y, Tamakoshi K, Matsushima M, Kawabe T. Comparison of salivary cortisol, heart rate, and oxygen saturation between early skin-to-skin contact with different initiation and duration times in healthy, full-term infants. Early Hum Dev. 2011 Mar;87(3):151-7. doi: 10.1016/j.earlhumdev.2010.11.012. Epub 2011 Jan 8.

  PMID: 21220191 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: May 4, 2025
• Study Start: May 15, 2022
• Primary Completion: September 15, 2022
• Study Completion: June 15, 2023
• Last Updated: May 4, 2025

Record last verified: 2025-05

Locations

TU (1)