NCT07248215

Brief Summary

Support programs and training should be provided to parents by healthcare professionals, especially neonatal nurses and midwives, in line with these basic newborn care needs. Fathers, in particular, express a greater need for training because they feel less competent than mothers in newborn care. The concept of self-efficacy was first introduced by Bandura and defined as "individuals' beliefs in their capacity to organize and perform the actions necessary to perform assigned tasks". Self-efficacy is, in another definition, the belief that individuals have in themselves in the face of any situation they encounter, and these self-efficacy beliefs vary from situation to situation. If individuals have low self-efficacy, they will not find themselves competent in the situation they encounter and may not be able to do the task even if they have the capacity to do it. In this context, low self-efficacy levels of fathers in newborn care negatively affect their participation in care. During the prenatal period, expectant fathers' participation in childbirth preparation training and spending time with their partners allows them to focus on the baby and their partner's pregnancy. While the literature explores the emotions and experiences of pregnant women, studies on expectant fathers' cooperation during pregnancy, their self-efficacy for baby care, and their perception of spousal support are scarce. Therefore, this study aims to investigate the impact of basic newborn care training provided to expectant fathers with pregnant wives via a website on expectant fathers' self-efficacy and their wives' perception of spousal support during pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

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

Study Start

First participant enrolled

June 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2025

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

November 18, 2025

Last Update Submit

December 29, 2025

Conditions

Keywords

spousalsocial supportnewbornfatherself- efficacy

Outcome Measures

Primary Outcomes (3)

  • Personal Information Form

    The Personal Information Form was developed by the researcher for both expectant fathers and expectant mothers by reviewing relevant literature. The form for expectant fathers consists of eight open-ended and closed-ended questions inquiring about fathers' socio-demographic and paternal characteristics. The form for expectant mothers consists of six open-ended and closed-ended questions inquiring about fathers' socio-demographic and paternal characteristics.

    Before starting the study

  • Fathers' Newborn Care Self-Efficacy Scale (BYBÖÖ)

    Ergün Arslanlı et al. (2024) developed the scale, which consists of three subscales (Hygiene, Safety, and Nutrition) and 17 items safety, and nutrition. The scale is a five-point Likert-type scale, with scores ranging from 17 to 85. Higher scores indicate higher father self-efficacy in basic newborn care.

    The researcher administers the Fathers' Newborn Care Self-Efficacy Scale (FNSS) as a pre-test at the beginning of the study; the same scales are administered again at 3 months to collect post-test data.

  • Perception of Spousal Support During Pregnancy Scale (GEDAÖ)

    The scale consists of 16 items and three subscales. It can be used in studies with normal and high-risk pregnancies. The lowest possible score from the sixteen-item scale is 16, and the highest is 80. High scores on the scale should be interpreted as indicating high perceived spousal support during pregnancy, while low scores should be interpreted as indicating low perceived spousal support.

    The researcher administers the Fathers' Newborn Care Self-Efficacy Scale (FNSS) as a pre-test at the beginning of the study; the same scales are administered again at 3 months to collect post-test data.

Study Arms (2)

Website

EXPERIMENTAL

In this study, a website called "https://www.bebeklerinbakimi.com/" was created, consisting of scale items developed using literature reviews, research results, evidence-based practice guidelines, and videos prepared in accordance with the booklet.

Behavioral: Web Group

Routine Care

NO INTERVENTION

The researcher will not perform any neonatal care interventions in this group; they will continue to receive routine care at the midwifery school.

Interventions

Web GroupBEHAVIORAL

Fathers who agree to participate in the study will attend routine follow-up and training provided by the midwifery school during data collection, and then participate in baby care training provided by the researcher. These training sessions will be provided within the last three months of pregnancy for fathers whose wives are in their last trimester. This will allow the prospective fathers to learn how to use the website and log in for the first time under the researcher's guidance.

Website

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study required the following criteria for participating fathers:
  • Their wife's pregnancy was in the third trimester
  • They were over 18 and under 50
  • They agreed to participate in the study and signed the voluntary consent form
  • They had internet access on their phone
  • They knew how to use a telephone
  • They could read and understand Turkish
  • They were oriented to place, time, and person
  • They had no problems with their wife's pregnancy
  • They had no communication or visual impairments.
  • The study included mothers who were:
  • Pregnant women were included if they:
  • were over 18 but under 50 years old
  • were in their third trimester of pregnancy
  • agreed to participate in the study and signed the voluntary consent form
  • +4 more criteria

You may not qualify if:

  • participated in the study but did not wish to continue in the future
  • had a child or spouse develop a health problem during the study period
  • did not visit the website during their wife's pregnancy or did not follow the practices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ÇANKIRI KARATEKİN ÜNİVERSİTESİ SAĞLIK BİLİMLERİ FAKÜLTESİ Hemşirelik Bölümü

Çankırı, Çankırı Merkez, 18100, Turkey (Türkiye)

Location

Related Publications (3)

  • Shorey S, Ng YPM, Siew AL, Yoong J, Morelius E. Effectiveness of a Technology-Based Supportive Educational Parenting Program on Parental Outcomes in Singapore: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Jan 10;7(1):e4. doi: 10.2196/resprot.8062.

  • Shorey S, Dennis CL, Bridge S, Chong YS, Holroyd E, He HG. First-time fathers' postnatal experiences and support needs: A descriptive qualitative study. J Adv Nurs. 2017 Dec;73(12):2987-2996. doi: 10.1111/jan.13349. Epub 2017 Jun 21.

  • Ergun Arslanli S, Celebioglu A, Celik I, Uzun NB. Development and Psychometric Testing of the Fathers' Self-Efficacy Scale for Newborn Care. Asian Nurs Res (Korean Soc Nurs Sci). 2024 May;18(2):97-105. doi: 10.1016/j.anr.2024.04.001. Epub 2024 Apr 26.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The researcher will not be informed of the group placement of expectant fathers and mothers according to the randomization table before data collection, and the researcher will be blinded during group assignment. The researcher, who will also provide the training, will be blinded during the assignment of fathers to groups, but will not be blinded during the training and evaluation phases. Once the data collection process is complete, the data will be transferred to a computer and analyzed by an expert independent of the research. This will ensure that the researcher and the independent expert are blinded during data analysis and group assignment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This research will be conducted as a prospective pretest-posttest, two-group (1:1), randomized controlled experimental design.In the study, expectant fathers and pregnant women will be assigned to experimental and control groups using the block randomization method. The block randomization process was conducted via the website https://www.randomizer.org/. Within the scope of block randomization, 35 separate blocks were initially created, with two individuals in each group. The assignment of individuals within the blocks to the case and control groups was based on random numbers generated by https://www.randomizer.org/. For example, in this table, the first couple who met the study inclusion criteria and volunteered to participate was assigned to the experimental group, the second couple to the control group, the third couple to the expert are blinded during data analysis and group assignment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Lecturer

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

June 15, 2025

Primary Completion

December 1, 2025

Study Completion

December 26, 2025

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations