NCT07159477

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

TEN TENE TEMASIN BABA-BEBEK BAĞLANMASINA ETKİSİ: RANDOMİZE KONTROLLÜ ÇALIŞMA

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Çanakkale Onsekiz Mart University · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

Rationale: Early skin-to-skin contact may facilitate father-infant bonding; experimental evidence in Türkiye is limited. Design: Interventional, randomized, parallel assignment with three arms: * Early skin-to-skin contact: a single early skin-to-skin session. * Frequent skin-to-skin contact: repeated skin-to-skin sessions (e.g., ≥15 minutes per session on most days). * Standard care: routine postnatal care without a structured skin-to-skin schedule.Participants: Fathers ≥18 years with healthy term singleton newborns. Assessments: Paternal-Infant bonding is measured using a validated bonding scale at baseline and at a prespecified postpartum time point (e.g., 3 months). Additional baseline questionnaires are collected. Analysis plan (summary): Group comparisons and exploratory associations will be evaluated per protocol using appropriate statistical tests; full statistical details are provided in the Results section upon completion.

Conditions

• Newborn Basic Care Training
• Newborn Infant
• Attachment
• Bonding

Interventions

Type	Name	Description
BEHAVIORAL	Skin to Skin contact	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.

Timeline

• Start date: 2023-01-30
• Primary completion: 2024-04-15
• Completion: 2025-02-05
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

1 site across 1 country: Turkey (Türkiye)