Baby CareNCT05869019
Self-efficacy Scale for Mothers of Premature Babies
A study testing education in people with Baby Care, run by Eskisehir Osmangazi University.
Trial summary
The aim of this study is to develop a scale to determine the self-efficacy of mothers of premature infants in individualized developmental care practices. This study consists of two stages. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Baby Care
- What is being tested?
- education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Nov 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mothers of premature babies whose babies were discharged from the Neonatal Intensive Care Unit (NICU) (training will be given immediately after the baby is discharged),
- Continuing prematurity of the baby according to the corrected age,
- Full-time care of the baby at home by the mother,
- Mothers can speak and understand Turkish,
- Voluntary written and verbal informed consent was obtained from the mothers.
Who cannot join
- Being a term baby
- The mother has an ongoing psychological diagnosis,
- The mothers' unwillingness to continue working at any stage of the study.
About this study
Official title: Developing and Implementing the Self-Efficacy Scale of Mothers of Premature Infants Based on Individualized Developmental Care
The aim of this study is to develop a scale to determine the self-efficacy of mothers of premature infants in individualized developmental care practices.
This study consists of two stages. In the first stage, it is planned to develop a scale to determine the self-efficacy levels of mothers of premature babies based on individualized developmental care. In the second stage, the scale will be applied. At this stage, families will be trained for individualized developmental care and the effectiveness of the education will be evaluated through the developed scale.
Read more
For the first stage of the study, it is stated in the literature that at least 5 times the number of items should be taken in determining the sample size during the scale development stage, and 10 times in order to increase the reliability of the scale. In this study, after creating the scale items, a pilot application will be made with 3 mothers. Feedback will be received from mothers regarding the clarity of the questions and the scale will be finalized according to the feedback received. Then, the scale will be applied to the participant with a size of at least 10 times the number of scale items.
For the second phase of the study, firstly, a preliminary application will be made with 10 mothers who meet the inclusion criteria and agree to participate in the study. The number of samples to be taken for the second stage of the research will be determined by performing power analysis with the findings obtained. Mothers included in the preliminary application will not be included in the study. It is planned to use stratified block randomization method in the study. First, mothers will be stratified according to their education level and the total number of children they have, then an equal number of (blocking) mothers will be assigned to each group.
Data will be collected after obtaining written permission from the institution where the research will be conducted. "Descriptive Information Form", "Informed Voluntary Consent Form" prepared by the researchers and "Individualized Developmental Care Based Premature Baby Mothers' Self-Efficacy Scale" will be used in data collection.
- Conditions
- Baby Care
- Being tested
- education
- Keywords
- prematüre, mother, scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
Premature baby care training will be provided.
| Study group | Role | What they receive |
|---|---|---|
| providing education | Experimental | There are two groups, training and non-training. Receives: Other: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant care activities of mothers of premature infants will be evaluated with the Self-Efficacy Scale for Mothers of Premature Infants Based on Individualized Developmental Care.
Implementing the Self-Efficacy Scale of Mothers of Premature Infants Based on Individualized Developmental Care
Measured: On the first day of the babies' discharge, face-to-face interviews will be provided with mothers.
Secondary outcomes (1)
Infant care activities of mothers of premature infants will be evaluated with the Self-Efficacy Scale for Mothers of Premature Infants Based on Individualized Developmental Care.
Implementing the Self-Efficacy Scale of Mothers of Premature Infants Based on Individualized Developmental Care
Measured: Face-to-face interviews will be provided with mothers 15 days after their babies are discharged from the premature intensive care unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Baby CareStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Karaca, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869019
- Sponsor's protocol ID
- DOKTORA TEZ AYSEGUL
- Status last verified
- Sep 2023
- First submitted
- 10 Apr 2023
- Last updated
- 5 Sep 2023
- 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 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Implementing the Self-Efficacy Scale of Mothers of Premature Infants Based on Individualized Developmental Care
- ClinicalTrials.gov ID
- NCT05869019
- Acronym / sponsor ID
- DOKTORA TEZ AYSEGUL
- Conditions
- Baby Care
- Keywords
- prematüre, mother, scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 22 May 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.
The aim of this study is to develop a scale to determine the self-efficacy of mothers of premature infants in individualized developmental care practices.
This study consists of two stages. In the first stage, it is planned to develop a scale to determine the self-efficacy levels of mothers of premature babies based on individualized developmental care. In the second stage, the scale will be applied. At this stage, families will be trained for individualized developmental care and the effectiveness of the education will be evaluated through the developed scale.
For the first stage of the study, it is stated in the literature that at least 5 times the number of items should be taken in determining the sample size during the scale development stage, and 10 times in order to increase the reliability of the scale. In this study, after creating the scale items, a pilot application will be made with 3 mothers. Feedback will be received from mothers regarding the clarity of the questions and the scale will be finalized according to the feedback received. Then, the scale will be applied to the participant with a size of at least 10 times the number of scale items.
For the second phase of the study, firstly, a preliminary application will be made with 10 mothers who meet the inclusion criteria and agree to participate in the study. The number of samples to be taken for the second stage of the research will be determined by performing power analysis with the findings obtained. Mothers included in the preliminary application will not be included in the study. It is planned to use stratified block randomization method in the study. First, mothers will be stratified according to their education level and the total number of children they have, then an equal number of (blocking) mothers will be assigned to each group.
Data will be collected after obtaining written permission from the institution where the research will be conducted. "Descriptive Information Form", "Informed Voluntary Consent Form" prepared by the researchers and "Individualized Developmental Care Based Premature Baby Mothers' Self-Efficacy Scale" will be used in data collection.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| providing education | Experimental | Other: educationThere are two groups, training and non-training. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Mothers of premature babies whose babies were discharged from the Neonatal Intensive Care Unit (NICU) (training will be given immediately after the baby is discharged),
- Continuing prematurity of the baby according to the corrected age,
- Full-time care of the baby at home by the mother,
- Mothers can speak and understand Turkish,
- Voluntary written and verbal informed consent was obtained from the mothers.
Key exclusion criteria (3 listed)
- Being a term baby
- The mother has an ongoing psychological diagnosis,
- The mothers' unwillingness to continue working at any stage of 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 |
|---|---|---|
| educationPremature baby care training will be provided. | Other | providing education |
Primary outcome
Infant care activities of mothers of premature infants will be evaluated with the Self-Efficacy Scale for Mothers of Premature Infants Based on Individualized Developmental Care.
Time frame: On the first day of the babies' discharge, face-to-face interviews will be provided with mothers.
Implementing the Self-Efficacy Scale of Mothers of Premature Infants Based on Individualized Developmental Care
1 secondary outcome
Infant care activities of mothers of premature infants will be evaluated with the Self-Efficacy Scale for Mothers of Premature Infants Based on Individualized Developmental Care.
Time frame: Face-to-face interviews will be provided with mothers 15 days after their babies are discharged from the premature intensive care unit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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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 in people with Baby Care, run by Eskisehir Osmangazi 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 5 inclusion and 3 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 5 Sep 2023. 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?
Infant care activities of mothers of premature infants will be evaluated with the Self-Efficacy Scale for Mothers of Premature Infants Based on Individualized Developmental Care. (time frame: On the first day of the babies' discharge, face-to-face interviews will be provided with mothers.). 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 5 Sep 2023.