NCT06163066

Brief Summary

This study is planned to be carried out in a pre-test-post-test (first and fourth months) randomized controlled experimental design with the aim of determining the "Effect of Newborn Basic Care Training Given to Fathers with Different Methods on Fathers' Self-Efficacy and Father-Infant Attachment". In addition, the training provided aims to prevent malpractices in newborn care and to reduce neonatal morbidity and mortality rates and gender-based inequalities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

May 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

November 30, 2023

Last Update Submit

August 25, 2025

Conditions

Keywords

FathersSelf-efficacyNewborn careAttachmentNursing

Outcome Measures

Primary Outcomes (2)

  • Fathers' Self-Efficacy Scale for Newborn Care

    This scale, developed by researchers, consists of 3 sub-dimensions (Hygiene, Safety and Nutrition). The hygiene sub-dimension consists of 10 items, the security sub-dimension consists of 4 items, and the nutrition sub-dimension consists of 3 items, making a total of 17 items. Each item of the scale is scored from 1 to 5, and the lowest score obtained from the scale is 17 and the highest score is 85. A high score means that the father's self-efficacy in basic newborn care is high.

    Change from within the first 24 hours of postpartum, after Newborn basic care training is completed (first month and fourth months) after Newborn basic care training is completed

  • Postnatal Paternal-Infant Attachment Scale

    The Postnatal Paternal-infant attachment scale is a scale developed by Condon et al. (2008) to evaluate postnatal paternal-infant attachment after birth (Condon et al., 2008). This scale was adapted to Turkish society by Güleç and Kavlak (2013) and its validity and reliability were tested. The scale consists of 3 sub-dimensions and 19 items. Each item of the scale is scored from 1 to 5, and the lowest score obtained from the scale is 19 and the highest score is 95. A high score means that attachment is high.

    Change from within the first 24 hours of postpartum, after Newborn basic care training is completed (first month and fourth months) after Newborn basic care training is completed

Study Arms (3)

Web-based Group

EXPERIMENTAL

The father's phone will be stolen and the father will record the researcher's phone number. After this stage, the researcher will apply a pre-test, make the father a member of the website and show the first video about basic newborn care to the father via his phone. The first access to the website will be made under the guidance of the researcher. For membership, individuals must have an internet connection and know how to use a phone. Even though the fathers made their first viewing before being discharged from the hospital, the web page will be open for 1 month and they will be able to watch the video they want whenever they want. Individuals who visit the page and agree to participate in the study will be given a posttest at the end of the 1st month and at the end of the 4th month.

Other: Newborn Basic Care Training

Face-to-face Group

EXPERIMENTAL

The father's phone will be stolen and the father will record the researcher's phone number. Then, before his wife is discharged from the hospital, the father will be interviewed and an appointment will be made to meet at the clinic at a convenient time. During this appointment, the researcher will apply a pre-test and explain information about basic newborn care (hygiene, safety and nutrition) face-to-face and in practice. In addition, brochures about baby care will be provided to fathers that they can use at any time. After this process, the final test will be applied at the end of the 1st month and at the end of the 4th month.

Other: Newborn Basic Care Training

Control Group

NO INTERVENTION

The father's phone will be stolen and the father will record the researcher's phone number. After this stage, the researcher will perform a pre-test before the mother is discharged and will not have her perform any newborn care procedures. Fathers in the control group will continue to receive routine care. In Turkey, information about the basic care of the newborn is given only verbally by neonatal midwives and nurses before discharge. After these procedures, a final test will be applied to this group at the end of the 1st month and at the end of the 4th month.

Interventions

These talented fathers will be given both face-to-face practical training and the industrial web-based training type of information technologies will be used. In this way, the positive developments provided by the two trainings will be abandoned and the understandability and usefulness of the training from the people's perspective will be increased. A website suitable for mobile phones will be designed by transferring digital materials. With this website, fathers will be able to access information about basic care via phone whenever and wherever they want. Thus, in a short time, without human resources and time, all the fathers in need throughout the country will reach the capacity to obtain appropriate information.

Face-to-face GroupWeb-based Group

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsWhen the literature is examined, it is seen that there are a limited number of studies investigating fathers' participation in baby care and postnatal father-infant attachment. There is no study in the literature that specifically addresses the self-efficacy of fathers who are expecting their first baby or have a newborn baby, regarding the basic care of the newborn. For this reason, this study will be conducted to determine "the effect of newborn basic care training given with different methods on fathers' self-efficacy in care and father-infant attachment".
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Fathers who participated in the study but withdrew at any point, whose child or spouse experienced health complications after childbirth, or who failed to access the website within one month or engage with the educational materials, were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çankırı Karatekin University

Çankırı, 18000, Turkey (Türkiye)

Location

Study Officials

  • Sevilay ERGUN ARSLANLI, Phd Candidate

    Çankırı Karatekin University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study will be conducted in a prospective pretest-posttest (first and fourth months) three-arm (1:1:1), randomized controlled experimental design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer (PhD)

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 8, 2023

Study Start

May 2, 2024

Primary Completion

June 30, 2024

Study Completion

September 30, 2024

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations