- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06163066
Newborn Basic Care Training on Fathers' Self-Efficacy and Father-Baby Attachment
The Effect of Newborn Basic Care Training Delivered With Different Methods on Fathers' Self-Efficacy and Father-Baby Attachment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Çankırı, Turkey (Türkiye), 18000
- Çankırı Karatekin University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria Eligible participants were fathers who met the following criteria: (1) their spouse had given birth for the first time, (2) they were aged 18 to 50 years, (3) they consented to participate in the study and signed an informed consent form, (4) their infant was in the neonatal period, (5) they had access to a mobile phone with internet connectivity and were able to operate it, (6) they were able to read and understand xxx, (7) they had a stable living environment, (8) their child and spouse were in good health, and (9) they had no communication or visual impairments.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Web-based Group
The father's phone number will be recorded, and the researcher's contact information will be provided to the father for follow-up purposes.
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.
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Participating fathers will receive both face-to-face practical training and web-based educational interventions.
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.
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Experimental: Face-to-face Group
The father's phone number will be recorded, and the researcher's contact information will be provided to the father for follow-up purposes.
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.
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Participating fathers will receive both face-to-face practical training and web-based educational interventions.
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.
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No Intervention: Control Group
The father's phone number will be recorded, and the researcher's contact information will be provided to the father for follow-up purposes.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fathers' Self-Efficacy Scale for Newborn Care
Time Frame: 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
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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.
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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
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Postnatal Paternal-Infant Attachment Scale
Time Frame: 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
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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.
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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
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sevilay ERGUN ARSLANLI, Phd Candidate, Çankırı Karatekin University
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Sevilay ERGUN ARSLANLI
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
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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