Çanakkale Onsekiz MArt University Hospital
Çanakkale, 17100, Turkey (Türkiye)
NCT Number: NCT07159477
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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Interventional
Not applicable
Çanakkale, 17100, Turkey (Türkiye)
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 3 months postpartum
Subscale of the PIAS; higher scores indicate stronger bonding. Administered at the postpartum assessment.
Time frame: 3 months postpartum
Subscale of the PIAS; higher scores indicate stronger bonding. Administered at the postpartum assessment.
Time frame: 3 months postpartum
Subscale of the PIAS; higher scores indicate stronger bonding. Administered at the postpartum assessment.
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.
Time frame: Up to 3 months postpartum
Average daily minutes of skin-to-skin contact reported by fathers at the postpartum assessment.
Çanakkale Onsekiz Mart University
Other
TEN TENE TEMASIN BABA-BEBEK BAĞLANMASINA ETKİSİ: RANDOMİZE KONTROLLÜ ÇALIŞMA
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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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