TEN TENE TEMASIN BABA-BEBEK BAĞLANMASINA ETKİSİ: RANDOMİZE KONTROLLÜ ÇALIŞMA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- Paternal-Infant Attachment Scale (PIAS) Total Score at 3 Months Postpartum
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- Male
- Accepts 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
Arms & Interventions
Fathers who received standard care (SC):
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):
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.
Intervention: Skin to Skin contact (Behavioral)
Frequent skin-to-skin contact group (FSSC):
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.
Intervention: Skin to Skin contact (Behavioral)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Nazli Emel Ozer Yurdal
Principal Investigator
Çanakkale Onsekiz Mart University