Effect of Skin-to-Skin Contact on Father-Infant Bonding: A Randomized Controlled Trial

NCT07159477 | Completed DMC

• 1 other identifier: 2023-YÖNP-0008
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, parallel-group clinical trial evaluates whether father-infant skin-to-skin contact improves bonding among healthy term newborns and their fathers in Türkiye. Fathers are randomly assigned to one of three arms that differ in the timing and frequency of skin-to-skin contact (early one-time contact, frequent contact, or standard care). Bonding is assessed with a validated paternal-infant bonding scale at prespecified postpartum time points. The study enrolls fathers of newborns delivered in university and state hospital obstetrics units.

Conditions

Newborn Basic Care Training; Newborn Infant; Attachment; Bonding

Keywords

Bonding, Fathers, Newborn.

Outcome Measures

Primary Outcomes (1)

• Paternal-Infant Attachment Scale (PIAS) Total Score at 3 Months Postpartum

  Assessed with the Paternal-Infant Attachment Scale (PIAS). The PIAS has 19 items in three subscales and yields a total score from 19 to 95 points; higher scores indicate stronger father-infant bonding. The PIAS is self-reported by fathers at the postpartum assessment.

  3 months postpartum

Secondary Outcomes (5)

• Patience and Tolerance Subscale Score (PIAS) at 3 Months Postpartum

  3 months postpartum

• Pleasure in Interaction Subscale Score (PIAS) at 3 Months Postpartum

  3 months postpartum

• Affection and Pride Subscale Score (PIAS) at 3 Months Postpartum

  3 months postpartum

• Frequency of Father-Infant Skin-to-Skin Contact (days/week)

  Up to 3 months postpartum

• Daily Minutes of Father-Infant Skin-to-Skin Contact

  Up to 3 months postpartum

Study Arms (3)

Fathers who received standard care (SC):

NO INTERVENTION

No intervention was given to the fathers in this group according to their order of participation in the study. In the second interview with these fathers, after the data were collected, they were given information and brochures about skin-to-skin contact.

Early skin-to-skin contact group (ESSC):

EXPERIMENTAL

Fathers in this group, in order to participate in the study, were allowed to have skin-to-skin contact with their babies only once and for at least 15 minutes within the first 4 hours after birth, after the mother and baby had skin-to-skin contact after the baby was born and the baby was breastfed. If the father had any questions about skin-to-skin contact, they were given an explanation, and their questions were answered.

Behavioral: Skin to Skin contact

Frequent skin-to-skin contact group (FSSC):

EXPERIMENTAL

Fathers in this group, according to the order of participation in the study, were provided skin-to-skin contact with their babies for at least 15 minutes within the first 4 hours after birth, after which skin-to-skin contact was established between the mother and baby after the baby was born and the baby was breastfed and within the first 4 hours after birth. However, skin-to-skin contact with babies by fathers in this group was repeated at least once a day for at least 15 minutes in the hospital until the baby was discharged. After the mother and baby were discharged, fathers were asked to continue skin-to-skin contact at home for at least 15 minutes at least once a day or at least six days a week. In addition, a brochure prepared in accordance with the literature was given to these fathers.

Behavioral: Skin to Skin contact

Interventions

Skin to Skin contact BEHAVIORAL

Fathers are briefed on skin-to-skin: what it is/isn't, why it matters, how to do it, and benefits for father, mother, and baby. Keep the room quiet; close windows to avoid drafts. Do not perform if the father is sleeping. Smokers must not perform while smoking and should do it before smoking when possible. After mother-infant skin-to-skin and breastfeeding, start father-infant contact within four hours of birth. If clothing is unsuitable, provide a surgical gown. Place the diapered infant upright on the father's bare chest. The father supports shoulders and back, maintains eye contact, speaks softly, and touches the baby. Cover both with a blanket; only mother, father, and infant remain, with the researcher silent. Continue at least 15 minutes; end if the father requests care or the infant needs care (diapering, dressing, breastfeeding). Repeat once for the early-contact group and at least daily until discharge for the frequent-contact group; on discharge, remind daily home practice.

Early skin-to-skin contact group (ESSC):; Frequent skin-to-skin contact group (FSSC):

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Fathers ≥18 years old
• First-time fathers
• At least primary school graduates
• Able to provide ≥15 minutes of skin-to-skin contact within 4 hours of birth
• No communication problems
• Co-resident with their spouses
• Infant: single, healthy newborn at 38-42 weeks' gestation and present with the mother
• (If applicable) Infant birth weight between 2500-4000 g

You may not qualify if:

• Fathers who could not be reached during data collection or follow-up
• Separation from the infant for more than one week during follow-up (e.g., hospitalization of the father or infant, long-term work travel)
• Infants requiring special care or with congenital anomalies/serious illness

Sponsors & Collaborators

• Çanakkale Onsekiz Mart University: lead

Study Sites (1)

Çanakkale Onsekiz MArt University Hospital

Çanakkale, 17100, Turkey (Türkiye)

Location

Related Publications (1)

• Yurdal NEO, Ozsoy S. Effect of skin to skin contact on father infant bonding in a randomized controlled trial. Sci Rep. 2025 Nov 19;15(1):40728. doi: 10.1038/s41598-025-24589-1.

  PMID: 41258333 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 8, 2025
• Study Start: January 30, 2023
• Primary Completion: April 15, 2024
• Study Completion: February 5, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

TU (1)