TEN TENE TEMASIN BABA-BEBEK BAĞLANMASINA ETKİSİ: RANDOMİZE KONTROLLÜ ÇALIŞMA
Phase: NA
Conditions: Newborn Basic Care Training, Newborn Infant, Attachment, Bonding
Sponsor: Çanakkale Onsekiz Mart University

COVER PAGE
OFFICIAL TITLE
Effect of Skin-to-Skin Contact on Father–Infant Bonding: A Randomized Controlled Tri
NCT NUMBER
[if available]
DOCUMENT TYPE
Study Protocol and Statistical Analysis Plan
DOCUMENT DATE
18 Jan 2023
UNIQUE PROTOCOL ID
2023-YÖNP-0008
VERSION
v1.0
LANGUAGE
English

Study Protocol and Statistical Analysis Plan
Official Title: Effect of Skin-to-Skin Contact on Father–Infant Bonding: A
Randomized Controlled Trial
Unique Protocol ID: 2023-YÖNP-0008
Document Type: Study Protocol and Statistical Analysis Plan (SAP)
Document Date: 29 Aug 2025
1. Synopsis
• Design: Interventional, randomized, parallel-group, three-arm study conducted in
maternity units.
• Arms: (A) Early one-time skin-to-skin contact; (B) Frequent skin-to-skin contact;
(C) Standard care comparator.
• Primary Endpoint: Paternal–Infant Attachment Scale (PIAS) total score at
approximately 3 months postpartum (points; higher scores indicate stronger
bonding).
• Secondary Endpoints: PIAS subscale scores; frequency (days/week) and daily
minutes of skin-to-skin contact; selected caregiving behaviors.
• Population: Adult fathers of healthy term singleton newborns.
• Setting: University and state hospital obstetrics units in Türkiye.
• Duration per participant: Baseline assessment soon after birth and a follow-up
assessment around 3 months postpartum.
2. Background and Rationale
Skin-to-skin contact between caregivers and newborns is a simple, low-cost
practice that may foster early bonding. Experimental evidence focusing on fathers
is comparatively limited in Türkiye. This study evaluates whether structured
father–infant skin-to-skin contact schedules enhance bonding versus standard care.
3. Objectives
Primary Objective. To determine whether father–infant skin-to-skin contact
improves paternal–infant bonding compared with standard care.
Secondary Objectives. To compare subscale scores of bonding, describe skin-to-skin
frequency and duration, and explore associations with selected caregiving
behaviors and sociodemographic factors.
4. Endpoints
Primary Endpoint. PIAS total score at 3 months postpartum.
Secondary Endpoints. PIAS subscale scores; frequency of skin-to-skin (days/week);
daily minutes of skin-to-skin; indicators of paternal involvement.
5. Trial Design

Randomized, parallel assignment with three arms and approximately equal
allocation. The early one-time arm includes a single skin-to-skin session soon after
birth. The frequent arm includes repeated sessions (e.g., at least 15 minutes per
session on most days). The comparator arm receives routine postnatal care without
a structured schedule.
6. Study Setting
The study is conducted in obstetrics units of a university research hospital and a
state hospital in Türkiye.
7. Eligibility Criteria
Inclusion Criteria:
• Fathers aged 18 years or older.
• First-time fathers residing with the mother and infant.
• Able to provide skin-to-skin contact (e.g., sessions of approximately 15 minutes)
within a defined post-birth window.
• At least primary school education.
• Infant: healthy, term (≈38–42 weeks’ gestation), singleton, with birth weight
within an acceptable range per protocol.
Exclusion Criteria:
• Significant communication barriers or conditions limiting informed consent.
• Infants requiring special care or with major congenital anomalies/serious illness.
• Sustained separation from the infant (e.g., prolonged hospitalization or travel)
that precludes scheduled follow-up.
8. Interventions
Early One-Time Skin-to-Skin: A single supervised session of skin-to-skin contact
shortly after delivery, following unit procedures.
Frequent Skin-to-Skin: Repeated sessions encouraged at home and/or during
postnatal stays (e.g., on most days of the week), each lasting approximately 15
minutes, as feasible for the family.
Standard Care: Routine postnatal care without a structured skin-to-skin schedule;
families may practice contact ad libitum per usual care.
9. Assessments and Schedule
Assessments include a baseline questionnaire administered soon after birth and a
follow-up evaluation at approximately 3 months postpartum, which includes the
PIAS. Additional questionnaires capture frequency (days/week) and daily minutes of
skin-to-skin, and caregiving behaviors. All assessments are performed with
standardized instructions.
10. Safety Considerations

This is a minimal-risk behavioral study. No investigational drugs or devices are
used. Adverse events are not anticipated beyond transient discomfort from holding
position. Any unexpected concerns reported by participants will be documented and
managed according to institutional policies.
11. Ethics and Oversight
The study was reviewed and approved by an institutional ethics committee. Written
informed consent is obtained from all participating fathers prior to enrollment. The
protocol adheres to the principles of the Declaration of Helsinki and relevant
national regulations.
12. Data Management and Confidentiality
Data are recorded on de-identified forms and stored securely. Access to identifiable
information is restricted to authorized personnel. Results will be disseminated in
aggregate form without personal identifiers.

Statistical Analysis Plan (SAP)
This SAP outlines analyses for the primary and secondary endpoints, populations
for analysis, handling of missing data, and statistical thresholds. Analyses use a
two-sided alpha of 0.05 unless otherwise noted.
13. Analysis Populations
Intent-to-Treat (ITT): All randomized participants with at least one post-baseline
assessment. Per-Protocol (PP): Subset without major protocol deviations.
14. Descriptive Statistics
Continuous variables: mean, standard deviation, median, minimum, and maximum.
Categorical variables: counts and percentages.
15. Primary Endpoint Analysis
Group comparisons of PIAS total scores at 3 months postpartum will be performed
using a nonparametric omnibus test (e.g., Kruskal–Wallis). If the omnibus test is
significant, post-hoc pairwise comparisons will be conducted with appropriate
adjustments for multiplicity.
16. Secondary Analyses
Subscale scores will be analyzed analogously to the primary endpoint. Exploratory
analyses may assess associations between bonding outcomes and selected
caregiving behaviors or demographic variables using correlation and regression
models, with model assumptions checked and documented.
17. Covariates and Sensitivity Analyses
Potential covariates (e.g., education level, partner’s employment, caregiving
involvement) may be considered in adjusted models. Sensitivity analyses may
exclude participants with major deviations or missing key assessments.
18. Missing Data Handling
Extent and patterns of missing data will be summarized. Analyses will primarily use
available cases; if necessary, sensitivity analyses such as multiple imputation may
be considered consistent with the nonparametric framework.
19. Multiplicity and Software
Multiplicity adjustments will be applied to control type I error for multiple pairwise
tests when applicable. Analyses will be performed using standard statistical
software (e.g., SPSS, R, or Python).

20. Administrative Information
Sponsor/Institution: Çanakkale Onsekiz Mart University (ÇOMÜ). Study officials
and investigators are listed in the trial record. This document is intended for public
posting on ClinicalTrials.gov and does not include participant names or other
personally identifiable information.
Any deviations from this plan will be documented in the results section when
outcomes are reported.