- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07248215
The Effect of Newborn Basic Care Training Provided to Prospective Fathers Via a Website on Self-Efficacy and Perceptions of Spousal Support During Pregnancy (ENBC-T)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The neonatal period encompasses the first 28 days after birth. Babies born between 38 and 42 weeks are classified as term newborns, those born before 37 weeks as premature babies, and those born after 42 weeks as postmature babies. The newborn must experience physiological changes and adaptation in their body systems with birth. While completely dependent on the placenta for gas exchange, thermoregulation, nutrition, and excretion of metabolic products during the intrauterine period, they perform these functions independently after birth. However, because the newborn's systems are not fully developed like those of adults, they have difficulty performing these functions in the first days, and deviations from normal can occur within a short time. Therefore, ensuring and maintaining hemostasis in newborns is one of the primary goals of neonatal care. A baby's health and quality of care during the intrauterine, birth, and neonatal period affect their entire life. Therefore, a healthy newborn period, from birth to the intrauterine period, and optimally meeting their care needs will lay the foundation for the rest of their life. The most important of these care needs relate to the newborn's hygiene, safety, and nutrition. 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. Another study found that the self-efficacy levels of mothers and fathers in the intervention group improved after newborn care and parenting preparation training provided to parents in the early period through a mobile health application. Therefore, it is extremely important that fathers who care for newborns receive various trainings to increase their knowledge and skills about newborn care before and immediately after birth. 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. Furthermore, it has been reported that supporting their partners during pregnancy has a positive effect on the baby's cortisol levels in the intrauterine period and has a protective effect on the baby's health. It is emphasized that pregnant women often need spousal support during pregnancy and birth, that spousal support makes pregnancy less stressful, and that failure to provide adequate spousal support when needed can lead to irreversible problems. It has been reported that low perception of spousal support during pregnancy is associated with neonatal outcomes such as newborn weight, neonatal distress, and prematurity, and that it negatively affects mother-infant bonding and breastfeeding. 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.
H11: Basic newborn care education provided to expectant fathers through the website has a positive effect on fathers' self-efficacy.
H21: Basic newborn care education provided to expectant fathers through the website has a positive effect on expectant mothers' perception of spousal support during pregnancy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Çankırı Merkez
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Çankırı, Çankırı Merkez, Turkey (Türkiye), 18100
- ÇANKIRI KARATEKİN ÜNİVERSİTESİ SAĞLIK BİLİMLERİ FAKÜLTESİ Hemşirelik Bölümü
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
- knew how to use a telephone and had internet access on their phone
- could read and understand Turkish
- were oriented to place, time, and person
- had no communication or visual impairments.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Website
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.
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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.
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No Intervention: Routine Care
The researcher will not perform any neonatal care interventions in this group; they will continue to receive routine care at the midwifery school.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Personal Information Form
Time Frame: Before starting the study
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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.
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Before starting the study
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Fathers' Newborn Care Self-Efficacy Scale (BYBÖÖ)
Time Frame: 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.
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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.
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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.
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Perception of Spousal Support During Pregnancy Scale (GEDAÖ)
Time Frame: 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.
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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.
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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.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CankırıKaratekinUniversity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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