MotherNCT05438056
The Effect of the Mobile Application Developed for Home Care of Preterm
A study testing education with mobile application in people with Mother and Premature, run by Ankara University.
Trial summary
mobile application will be developed to support the post-discharge home care of mothers of premature babies. With the developed mobile application, the effect of the education given to the mothers on the knowledge and skills of infant care, mother-infant attachment, and the mother's self-efficacy will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- education with mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2022to 30 Dec 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For mothers;
- Being over the age of 18,
- Having a premature baby
- At least primary school graduate,
- Smart mobile app can be installed have a phone,
- Being able to understand and speak Turkish,
Show all 12Show fewer
- Residing in Ankara
- For babies;
- 32-37 weeks of gestation of the baby (middle and borderline premature)
- Baby in neonatal intensive care unit to stay
- Not having undergone a surgical operation,
- Absence of physical anomalies
Who cannot join
- For Mothers;
- Diagnosed with postpartum depression
- unwillingness to participate in the study
- For babies;
- Very small preterm (born below 28 weeks of gestation) and small preterm (between 28 and 31 weeks of gestation)
About this study
Official title: The Effect of the Mobile Application Developed for Home Care of the Premature Baby on the Mother's Baby Care Skills, Self-efficacy and Mother-infant Bonding
mobile application will be developed to support the post-discharge home care of mothers of premature babies. With the developed mobile application, the effect of the education given to the mothers on the knowledge and skills of infant care, mother-infant attachment, and the mother's self-efficacy will be evaluated.
Read the detailed description
This research aims to examine the effect of the mobile application developed for the home care of the babies of the mothers of premature babies on their baby care knowledge and skills, mother-infant attachment and mother self-efficacy. A mobile application will be developed to support mothers who care for their premature babies at home after discharge. The application will be installed on the phones of mothers whose babies are discharged from the neonatal intensive care unit. After the babies are discharged, mothers will be trained at home with a mobile application. Maternal self-efficacy and mother-infant supplementation will be measured when infants admitted the NICU and one month after discharge the NICU.
- Conditions
- Mother, Premature, Education, Home Care, Mobile Application
- Being tested
- education with mobile application
- Keywords
- Mothers, premature, mobile application, education, home care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education with mobile applicationOther
providing training to mothers of premature babies with a mobile application
| Study group | Role | What they receive |
|---|---|---|
| providing training to mothers of premature babies with a mobile application | Experimental | providing training with mobile application to mothers discharged home with their premature babies +standard education prior to discharge Receives: Other: education with mobile application |
| standard education prior to discharge control group; standard education prior to discharge | No intervention | standard education prior to discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
parent self-efficacy scale
scale that measures mother's self-efficacy for baby care.The unabridged name of the scale is parent self-efficacy scale. The lowest score obtained from the scale is 18, the highest score is 90. low score indicates high self-efficacy
Measured: up to 10 months
parent self-efficacy scale
scale that measures mother's self-efficacy for baby care.The unabridged name of the scale is parent self-efficacy scale. The lowest score obtained from the scale is 18, the highest score is 90. low score indicates high self-efficacy.
Measured: up to 14 months
Secondary outcomes (2)
maternal attachment scale
scale that measuring mother-infant attachment. The unabridged name of the scale is maternal attachment scale. The lowest score obtained from the scale is 26, the highest score is 104. A high score indicates high maternal attachment.
Measured: up to 10 months
maternal attachment scale
scale that measuring mother-infant attachment. The unabridged name of the scale is maternal attachment scale. The lowest score obtained from the scale is 26, the highest score is 104. A high score indicates high maternal attachment.
Measured: up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start16 Dec 2022 (estimated)
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MotherStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- randomized controlled interventional research
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin KORKMAZ YENİCE, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438056
- Sponsor's protocol ID
- AnkaraU06GKY
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When the study is completed and published, the score obtained from the parent self-efficacy scale and maternal attachment scale will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Mobile Application Developed for Home Care of the Premature Baby on the Mother's Baby Care Skills, Self-efficacy and Mother-infant Bonding
- ClinicalTrials.gov ID
- NCT05438056
- Acronym / sponsor ID
- AnkaraU06GKY
- Conditions
- Mother, Premature, Education, Home Care, Mobile Application
- Keywords
- Mothers, premature, mobile application, education, home care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 16 Dec 2022 (estimated)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 29 Jun 2022 (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.
mobile application will be developed to support the post-discharge home care of mothers of premature babies. With the developed mobile application, the effect of the education given to the mothers on the knowledge and skills of infant care, mother-infant attachment, and the mother's self-efficacy will be evaluated.
Detailed description
This research aims to examine the effect of the mobile application developed for the home care of the babies of the mothers of premature babies on their baby care knowledge and skills, mother-infant attachment and mother self-efficacy. A mobile application will be developed to support mothers who care for their premature babies at home after discharge. The application will be installed on the phones of mothers whose babies are discharged from the neonatal intensive care unit. After the babies are discharged, mothers will be trained at home with a mobile application. Maternal self-efficacy and mother-infant supplementation will be measured when infants admitted the NICU and one month after discharge the NICU.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled interventional research
| Arm | Type | Receives |
|---|---|---|
| providing training to mothers of premature babies with a mobile application | Experimental | Other: education with mobile applicationproviding training with mobile application to mothers discharged home with their premature babies +standard education prior to discharge |
| standard education prior to discharge control group; standard education prior to discharge | No intervention | –standard education prior to discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- For mothers;
- Being over the age of 18,
- Having a premature baby
- At least primary school graduate,
- Smart mobile app can be installed have a phone,
Key exclusion criteria (5 listed)
- For Mothers;
- Diagnosed with postpartum depression
- unwillingness to participate in the study
- For babies;
- Very small preterm (born below 28 weeks of gestation) and small preterm (between 28 and 31 weeks of gestation)
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 |
|---|---|---|
| education with mobile applicationproviding training to mothers of premature babies with a mobile application | Other | providing training to mothers of premature babies with a mobile application |
Primary outcome
parent self-efficacy scale
Time frame: up to 10 months
scale that measures mother's self-efficacy for baby care.The unabridged name of the scale is parent self-efficacy scale. The lowest score obtained from the scale is 18, the highest score is 90. low score indicates high self-efficacy
parent self-efficacy scale
Time frame: up to 14 months
scale that measures mother's self-efficacy for baby care.The unabridged name of the scale is parent self-efficacy scale. The lowest score obtained from the scale is 18, the highest score is 90. low score indicates high self-efficacy.
2 secondary outcomes
maternal attachment scale
Time frame: up to 10 months
maternal attachment scale
Time frame: up to 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Individual participant dataSharing planned: No. When the study is completed and published, the score obtained from the parent self-efficacy scale and maternal attachment scale will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing education with mobile application in people with Mother and Premature, run by Ankara University.
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 12 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 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
parent self-efficacy scale (time frame: up to 10 months). 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 1 Jul 2022.