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Completed

NCT Number: NCT07159477

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

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.

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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Çanakkale Onsekiz MArt University Hospital

Çanakkale, 17100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 3 months postpartum

    Subscale of the PIAS; higher scores indicate stronger bonding. Administered at the postpartum assessment.

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

    Time frame: 3 months postpartum

    Subscale of the PIAS; higher scores indicate stronger bonding. Administered at the postpartum assessment.

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

    Time frame: 3 months postpartum

    Subscale of the PIAS; higher scores indicate stronger bonding. Administered at the postpartum assessment.

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

    Time frame: Up to 3 months postpartum

    Number of days per week fathers report skin-to-skin contact with their infants, captured by questionnaire at the postpartum assessment.

  5. Daily Minutes of Father-Infant Skin-to-Skin Contact

    Time frame: Up to 3 months postpartum

    Average daily minutes of skin-to-skin contact reported by fathers at the postpartum assessment.

Sponsors and collaborators

Lead sponsor

Çanakkale Onsekiz Mart University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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