Newborn Basic Care TrainingNCT07159477
Effect of Skin-to-Skin Contact on Father-Infant Bonding: A Randomized Controlled Trial
A study testing Skin to Skin contact in people with Newborn Basic Care Training and Newborn Infant, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Newborn Basic Care Training, Newborn Infant, Attachment
- What is being tested?
- Skin to Skin contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2023to 5 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çanakkale Onsekiz MArt University Hospital
Çanakkale, 17100
About this study
Official title: TEN TENE TEMASIN BABA-BEBEK BAĞLANMASINA ETKİSİ: RANDOMİZE KONTROLLÜ ÇALIŞMA
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.
Read the 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
- Being tested
- Skin to Skin contact
- Keywords
- Bonding, Fathers, Newborn.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin to Skin contactBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Fathers who received standard care (SC): | No intervention | 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): | Experimental | 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. Receives: Behavioral: Skin to Skin contact |
| Frequent skin-to-skin contact group (FSSC): | Experimental | 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. Receives: Behavioral: Skin to Skin contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paternal-Infant Attachment Scale (PIAS) Total Score at 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.
Measured: 3 months postpartum
Secondary outcomes (5)
Patience and Tolerance Subscale Score (PIAS) at 3 Months Postpartum
Subscale of the PIAS; higher scores indicate stronger bonding. Administered at the postpartum assessment.
Measured: 3 months postpartum
Pleasure in Interaction Subscale Score (PIAS) at 3 Months Postpartum
Subscale of the PIAS; higher scores indicate stronger bonding. Administered at the postpartum assessment.
Measured: 3 months postpartum
Affection and Pride Subscale Score (PIAS) at 3 Months Postpartum
Subscale of the PIAS; higher scores indicate stronger bonding. Administered at the postpartum assessment.
Measured: 3 months postpartum
Frequency of Father-Infant Skin-to-Skin Contact (days/week)
Number of days per week fathers report skin-to-skin contact with their infants, captured by questionnaire at the postpartum assessment.
Measured: Up to 3 months postpartum
Daily Minutes of Father-Infant Skin-to-Skin Contact
Average daily minutes of skin-to-skin contact reported by fathers at the postpartum assessment.
Measured: Up to 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start30 Jan 2023
- Primary completion15 Apr 2024
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newborn Basic Care TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Emel Ozer Yurdal, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159477
- Sponsor's protocol ID
- 2023-YÖNP-0008
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analysed during the current study are available on the researcher's computer. The datasets used and/or analysed during the current study are available from the corresponding author upon reasonable request.
Publications
Yurdal NEO, Ozsoy S. Effect of skin to skin contact on father infant bonding in a randomized controlled trial. Sci Rep. 2025 Nov 19;15(1):40728. doi: 10.1038/s41598-025-24589-1.
PubMed 41258333
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEN TENE TEMASIN BABA-BEBEK BAĞLANMASINA ETKİSİ: RANDOMİZE KONTROLLÜ ÇALIŞMA
- ClinicalTrials.gov ID
- NCT07159477
- Acronym / sponsor ID
- 2023-YÖNP-0008
- Conditions
- Newborn Basic Care Training, Newborn Infant, Attachment, Bonding
- Keywords
- Bonding, Fathers, Newborn.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fathers who received standard care (SC): | No intervention | –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): | Experimental | Behavioral: Skin to Skin contactFathers 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. |
| Frequent skin-to-skin contact group (FSSC): | Experimental | Behavioral: Skin to Skin contactFathers 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin to Skin contactFathers 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. | Behavioural | Early skin-to-skin contact group (ESSC):, Frequent skin-to-skin contact group (FSSC): |
Primary outcome
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.
5 secondary outcomes
Patience and Tolerance Subscale Score (PIAS) at 3 Months Postpartum
Time frame: 3 months postpartum
Pleasure in Interaction Subscale Score (PIAS) at 3 Months Postpartum
Time frame: 3 months postpartum
Affection and Pride Subscale Score (PIAS) at 3 Months Postpartum
Time frame: 3 months postpartum
Frequency of Father-Infant Skin-to-Skin Contact (days/week)
Time frame: Up to 3 months postpartum
Daily Minutes of Father-Infant Skin-to-Skin Contact
Time frame: Up to 3 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 41258333Yurdal NEO, Ozsoy S. Effect of skin to skin contact on father infant bonding in a randomized controlled trial. Sci Rep. 2025 Nov 19;15(1):40728. doi: 10.1038/s41598-025-24589-1.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analysed during the current study are available on the researcher's computer. The datasets used and/or analysed during the current study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin to Skin contact in people with Newborn Basic Care Training and Newborn Infant, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paternal-Infant Attachment Scale (PIAS) Total Score at 3 Months Postpartum (time frame: 3 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07159477, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.