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

NCT ID: NCT07159477

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2025-02-05

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.

Conditions

Newborn Basic Care Training; Newborn Infant; Attachment; Bonding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Skin to Skin contact

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Skin to Skin contact

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Çanakkale Onsekiz Mart University

OTHER

Sponsor Role: lead

Responsible Party

Nazli Emel Ozer Yurdal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Çanakkale Onsekiz MArt University Hospital

Çanakkale, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2023-YÖNP-0008

Identifier Type: -

Identifier Source: org_study_id