Newborn Basic Care TrainingNCT06163066
Newborn Basic Care Training on Fathers' Self-Efficacy and Father-Baby Attachment
A study testing Newborn Basic Care Training in people with Newborn Basic Care Training, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial 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". Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Newborn Basic Care Training
- What is being tested?
- Newborn Basic Care Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Newborn Basic Care Training Delivered With Different Methods on Fathers' Self-Efficacy and Father-Baby Attachment
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.
Read the detailed description
This study will be conducted in a prospective pre-test-post-test- (first and fourth months), three-arm (1:1:1), randomized controlled experimental design.The sample size of the study was calculated based on a 3-group study on father-infant attachment. Thus, it was planned to conduct research with 75 fathers in total (25 fathers in the web-based group, 25 in the face-to-face group, and 25 in the control group).
- Conditions
- Newborn Basic Care Training
- Being tested
- Newborn Basic Care Training
- Keywords
- Fathers, Self-efficacy, Newborn care, Attachment, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newborn Basic Care TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-based Group | Experimental | 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. Receives: Other: Newborn Basic Care Training |
| Face-to-face Group | Experimental | 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. Receives: Other: Newborn Basic Care Training |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start2 May 2024
- Primary completion30 Jun 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn Basic Care TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be conducted in a prospective pretest-posttest (first and fourth months) three-arm (1:1:1), randomized controlled experimental design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevilay Ergun Arslanli, Çankırı Karatekin University
- Investigators
- Sevilay ERGUN ARSLANLI, Phd Candidate, Study director, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163066
- Sponsor's protocol ID
- Sevilay ERGUN ARSLANLI
- Status last verified
- Aug 2025
- First submitted
- 30 Nov 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Newborn Basic Care Training Delivered With Different Methods on Fathers' Self-Efficacy and Father-Baby Attachment
- ClinicalTrials.gov ID
- NCT06163066
- Acronym / sponsor ID
- Sevilay ERGUN ARSLANLI
- Conditions
- Newborn Basic Care Training
- Keywords
- Fathers, Self-efficacy, Newborn care, Attachment, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be conducted in a prospective pre-test-post-test- (first and fourth months), three-arm (1:1:1), randomized controlled experimental design.The sample size of the study was calculated based on a 3-group study on father-infant attachment. Thus, it was planned to conduct research with 75 fathers in total (25 fathers in the web-based group, 25 in the face-to-face group, and 25 in the control group).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study will be conducted in a prospective pretest-posttest (first and fourth months) three-arm (1:1:1), randomized controlled experimental design.
| Arm | Type | Receives |
|---|---|---|
| Web-based Group | Experimental | Other: Newborn Basic Care TrainingThe 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. |
| Face-to-face Group | Experimental | Other: Newborn Basic Care TrainingThe 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Newborn Basic Care TrainingParticipating 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. | Other | Face-to-face Group, Web-based Group |
Primary outcome
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
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
Related trials for Newborn Basic Care Training
Not yet recruiting
Kolb-Based AI-Powered Neonatal Simulation Training
Nursing Education
Not yet recruiting
DialysisBot: AI Chatbot for Hemodialysis Self-Management
Chatbot-Based Training, Hemodialysis
Active, not recruiting
Effects of NICU Scenario-Based Simulation on Nursing Students' Perceived Stress, Satisfaction, Self-Confidence, and Learning: A Mixed-Methods Study
Nursing Education, Simulation Based Learning
Not yet recruiting
Simulation-Based Training on Immediate Newborn Care
Newborn Care
Not yet recruiting
Effectiveness of Simulation-based Training Delivered to Special Newborn Care Providers on Resuscitation Management and Kangaroo Mother Care: Simulation-based Training for Asyphxia in Babies Trial (STAR-Baby Trial)
Newborn Asphyxia, Hypothermia Neonatal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevilay ERGUN ARSLANLI, Phd Candidate study director
Çankırı Karatekin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Newborn Basic Care Training in people with Newborn Basic Care Training, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.