Newborn; VitalityNCT05812833
Web-Based Baby Care Education Meleis' Transition Theory Mother's Self-Confidence Newborn Health
A study testing Education in people with Newborn; Vitality and Theory, Double Bind, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
Web-Based Baby Care Education Meleis' Transition Theory Mother's Self-Confidence Newborn Health Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Newborn; Vitality, Theory, Double Bind, Mother-Infant Interaction
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2023to 30 Jul 2023
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous pregnant
- Single pregnancy
- Expectant mothers with internet access,
- Expectant mothers who can use digital tools (Smartphone or computer)
- Mothers with healthy babies
- Mothers whose babies were born at term (between 37-42 GH)
Show all 9Show fewer
- Mothers discharged with their baby
- Those whose baby is with the mother
- Expectant mothers who do not attend pregnancy education classes
Who cannot join
- The mother has communication problems,
- The mother has a chronic illness,
- Having problems with breastfeeding (breast or newborn),
- The newborn has IUGR or genetic disease,
- Failure to attend training sessions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University
Fatih, Istanbul
Fatma Şule Tanrıverdi, Msc, 5413606482, sulebilgic@halic.edu.tr
About this study
Official title: The Effect of Web-Based Baby Care Education Based on Meleis' Transition Theory on Mother's Self-Confidence and Newborn Health
Web-Based Baby Care Education Meleis' Transition Theory Mother's Self-Confidence Newborn Health
Read the detailed description
When the mother is not self-confident; They cannot fulfill their motherhood role, have difficulty in establishing a relationship with their baby, and cannot raise their babies in a healthy way. It is easier for mothers who have the necessary knowledge and skills to care for the baby to adapt to this process. The educational support given in the transition to motherhood will affect the mother's self-confidence and readiness for motherhood, thus affecting the baby's health.
The research will be conducted on the online platform between November 2022 and November 2023. The population of the randomized controlled study was Istanbul Haseki Training and Research Hospital Sultan Gazi Haseki Campus, the pregnant women followed in the pregnant outpatient clinic, the sample was n: 45 pregnant women who attended the online training meeting the sample selection criteria, 45 pregnant women informed on the website, and 45 pregnant women in the control group, a total of 135 mothers. will form the candidate. Pregnant women who are willing to participate in the study will be assigned to the groups by simple randomization method. During the research, the CONSORT 2018 statement will be followed. Research data; Data Collection Form will be obtained by Pregnants' Readiness for Newborn Hygienic Care Scale, Karitane Parental Self-Confidence Scale, LACTH (Breastfeeding Success Assessment) Scale and Infant Follow-up Form.
- Being tested
- Education
- Keywords
- Meleis Transition Theory, infant health, online education, web page
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Also called consultancy
Pregnant women will be given online baby care training
| Study group | Role | What they receive |
|---|---|---|
| Participating in online training and providing active consultancy | Experimental | Online training will be given to mothers, and then the web link will be shared and online counseling will be given every week. Mothers will be followed for 3 months Receives: Behavioral: Education |
| Control | No intervention | Will receive routine maintenance of the institution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Education
Web-based online baby care training based on Meleis' Transition Theory to measures mothers' self-confidence
Measured: 16 weeks
Newborn
To evaluate more successful breastfeeding in infants of mothers who received web-based online infant care training based on Meleis' Transition Theory.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start30 Mar 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newborn; VitalityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Collaborators
- Gülçin Bozkurt
- Responsible party
- Principal investigator, Fatma Şule Bilgiç, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812833
- Sponsor's protocol ID
- PhD
- Status last verified
- Mar 2023
- First submitted
- 3 Aug 2022
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research data collection: 6 months Analysis of data: 3 Months Reporting and publication preparation: 3 Months
Publications
Bilgic FS, Bozkurt G. The Effect of Online Infant Care Education and Postpartum Counseling Based on Meleis's Transition Theory on Mothers' Self-Esteem and Infant Health: A Randomized Controlled Trial. Nurs Health Sci. 2025 Mar;27(1):e70045. doi: 10.1111/nhs.70045.
PubMed 39900549
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-Based Baby Care Education Based on Meleis' Transition Theory on Mother's Self-Confidence and Newborn Health
- ClinicalTrials.gov ID
- NCT05812833
- Acronym / sponsor ID
- PhD
- Keywords
- Meleis Transition Theory, infant health, online education, web page
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Collaborators
- Gülçin Bozkurt
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 14 Apr 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.
Web-Based Baby Care Education Meleis' Transition Theory Mother's Self-Confidence Newborn Health
Detailed description
When the mother is not self-confident; They cannot fulfill their motherhood role, have difficulty in establishing a relationship with their baby, and cannot raise their babies in a healthy way. It is easier for mothers who have the necessary knowledge and skills to care for the baby to adapt to this process. The educational support given in the transition to motherhood will affect the mother's self-confidence and readiness for motherhood, thus affecting the baby's health.
The research will be conducted on the online platform between November 2022 and November 2023. The population of the randomized controlled study was Istanbul Haseki Training and Research Hospital Sultan Gazi Haseki Campus, the pregnant women followed in the pregnant outpatient clinic, the sample was n: 45 pregnant women who attended the online training meeting the sample selection criteria, 45 pregnant women informed on the website, and 45 pregnant women in the control group, a total of 135 mothers. will form the candidate. Pregnant women who are willing to participate in the study will be assigned to the groups by simple randomization method. During the research, the CONSORT 2018 statement will be followed. Research data; Data Collection Form will be obtained by Pregnants' Readiness for Newborn Hygienic Care Scale, Karitane Parental Self-Confidence Scale, LACTH (Breastfeeding Success Assessment) Scale and Infant Follow-up Form.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled
| Arm | Type | Receives |
|---|---|---|
| Participating in online training and providing active consultancy | Experimental | Behavioral: EducationOnline training will be given to mothers, and then the web link will be shared and online counseling will be given every week. Mothers will be followed for 3 months |
| Control | No intervention | –Will receive routine maintenance of the institution |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Primiparous pregnant
- Single pregnancy
- Expectant mothers with internet access,
- Expectant mothers who can use digital tools (Smartphone or computer)
- Mothers with healthy babies
Key exclusion criteria (5 listed)
- The mother has communication problems,
- The mother has a chronic illness,
- Having problems with breastfeeding (breast or newborn),
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 |
|---|---|---|
| EducationAlso: consultancyPregnant women will be given online baby care training | Behavioural | Participating in online training and providing active consultancy |
Primary outcome
Education
Time frame: 16 weeks
Web-based online baby care training based on Meleis' Transition Theory to measures mothers' self-confidence
Newborn
Time frame: 16 weeks
To evaluate more successful breastfeeding in infants of mothers who received web-based online infant care training based on Meleis' Transition Theory.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Derived from this study: PubMed 39900549Bilgic FS, Bozkurt G. The Effect of Online Infant Care Education and Postpartum Counseling Based on Meleis's Transition Theory on Mothers' Self-Esteem and Infant Health: A Randomized Controlled Trial. Nurs Health Sci. 2025 Mar;27(1):e70045. doi: 10.1111/nhs.70045.
- Individual participant dataSharing planned: No. Research data collection: 6 months Analysis of data: 3 Months Reporting and publication preparation: 3 Months
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Newborn; Vitality and Theory, Double Bind, run by Halic 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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülçin Bozkurt, Prof (5414679620 ext. 12220, gulmeh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Education (time frame: 16 weeks). 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?
On the ClinicalTrials.gov record for NCT05812833, which also lists 1 linked publication.
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 14 Apr 2023.