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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07159477
Enrollment
165
Registered
2025-09-08
Start date
2023-01-30
Completion date
2025-02-05
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attachment, Bonding, Newborn Basic Care Training, Newborn Infant

Keywords

Bonding, Fathers, Newborn.

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.

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.

Interventions

BEHAVIORALSkin 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.

Sponsors

Çanakkale Onsekiz Mart University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Paternal-Infant Attachment Scale (PIAS) Total Score at 3 Months Postpartum3 months postpartumAssessed 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.

Secondary

MeasureTime frameDescription
Patience and Tolerance Subscale Score (PIAS) at 3 Months Postpartum3 months postpartumSubscale of the PIAS; higher scores indicate stronger bonding. Administered at the postpartum assessment.
Pleasure in Interaction Subscale Score (PIAS) at 3 Months Postpartum3 months postpartumSubscale of the PIAS; higher scores indicate stronger bonding. Administered at the postpartum assessment.
Affection and Pride Subscale Score (PIAS) at 3 Months Postpartum3 months postpartumSubscale of the PIAS; higher scores indicate stronger bonding. Administered at the postpartum assessment.
Frequency of Father-Infant Skin-to-Skin Contact (days/week)Up to 3 months postpartumNumber of days per week fathers report skin-to-skin contact with their infants, captured by questionnaire at the postpartum assessment.
Daily Minutes of Father-Infant Skin-to-Skin ContactUp to 3 months postpartumAverage daily minutes of skin-to-skin contact reported by fathers at the postpartum assessment.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026