The Impact of the Nurse-Led "My Baby is Safe" Educational Program
NCT ID: NCT07037914
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-07-31
2026-08-31
Brief Summary
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Detailed Description
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This study, which included postpartum mothers, was conducted at Amasya University between July 2025 and July 2026. Participants were randomly assigned to either the intervention group, which received the My Baby is Safe Educational Program (Group I), or the control group, which received standard care (Group II).
The intervention consisted of a nurse-led, individualized, repetitive educational program that began in the postpartum period and included home visits. The program aimed to inform mothers about risk and protective factors for SIDS and SBS, to encourage the creation and maintenance of a safe sleep environment, and to promote the use of appropriate soothing techniques for crying infants.
The study sample consisted of 50 mothers, with 25 mothers assigned to each group. Data collection instruments included: the Infant and Parent Information Form, Sudden Infant Death Syndrome Awareness Scale - Mother Form, the Sudden Infant Death Syndrome Care Skills Form, the Shaken Baby Syndrome Awareness Assessment Scale-Short Form, the Shaken Baby Syndrome Care Skills Form, the Sleep Environment Checklist, and the Perceived Maternal Parenting Self-Efficacy Scale.
Data were analyzed using the licensed Statistical Package for the Social Sciences (SPSS v.23) software of Akdeniz University. Repeated measures ANOVA was used to evaluate the changes over time between the groups and the interaction effects between group and time. Spearman correlation analysis was performed to assess relationships between variables. The significance level was set at p\<0.05. Additionally, effect sizes were calculated.
As a result, it is anticipated that the My Baby is Safe Educational Program will improve mothers' knowledge, skills, and self-efficacy related to the prevention of SIDS and SBS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Experimental: Group I-Education and Counseling
Education and Counseling
The researcher will inform the mothers (n=25) that the My Baby is Safe Educational Program will be delivered individually through distance education via Microsoft Teams at times convenient for them, and that the program will be completed over 5 days. The scheduling will ensure that all modules included in the My Baby is Safe Educational Program are completed within one week at the latest. Mothers will be informed that they can receive telephone counseling from the researcher until their infants reach two months of age, and the researcher's phone number will be provided to them. During this period, the researchers will send weekly reminder messages to the mothers' phones, encouraging them to read the provided educational booklet and to watch the educational videos.
The researcher will maintain communication with the mothers and conduct a home visit on the 15th day postpartum. During this home visit, the researcher will assess the infant's sleep environment for safe sleep practices.
Control: Group II-Leaflet
Leaflet
No structured or planned education will be provided to the control group by the researchers during the study period. After the first assessment, the mothers in the control group will receive a brochure prepared by the researchers based on the literature, containing brief informational notes on SIDS and SBS.
The researcher will maintain communication with the mothers and conduct a home visit on the 15th day postpartum. During this visit, the researcher will observe the home environment where the infant resides and evaluate the infant's sleep environment in terms of safe sleep practices.
After data collection from the intervention group has been completed, the same intervention (My Baby is Safe Educational Program) will also be delivered to the mothers in the control group.
Interventions
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Education and Counseling
The researcher will inform the mothers (n=25) that the My Baby is Safe Educational Program will be delivered individually through distance education via Microsoft Teams at times convenient for them, and that the program will be completed over 5 days. The scheduling will ensure that all modules included in the My Baby is Safe Educational Program are completed within one week at the latest. Mothers will be informed that they can receive telephone counseling from the researcher until their infants reach two months of age, and the researcher's phone number will be provided to them. During this period, the researchers will send weekly reminder messages to the mothers' phones, encouraging them to read the provided educational booklet and to watch the educational videos.
The researcher will maintain communication with the mothers and conduct a home visit on the 15th day postpartum. During this home visit, the researcher will assess the infant's sleep environment for safe sleep practices.
Leaflet
No structured or planned education will be provided to the control group by the researchers during the study period. After the first assessment, the mothers in the control group will receive a brochure prepared by the researchers based on the literature, containing brief informational notes on SIDS and SBS.
The researcher will maintain communication with the mothers and conduct a home visit on the 15th day postpartum. During this visit, the researcher will observe the home environment where the infant resides and evaluate the infant's sleep environment in terms of safe sleep practices.
After data collection from the intervention group has been completed, the same intervention (My Baby is Safe Educational Program) will also be delivered to the mothers in the control group.
Eligibility Criteria
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Inclusion Criteria
* Having a healthy newborn,
* Having one or more children,
* Having at least a primary school education,
* Having a smartphone and mobile internet access,
* Being able to speak, read, listen, and understand Turkish, able to follow instructions, and having no communication barriers,
* Voluntarily agreeing to participate in the study.
Exclusion Criteria
* Mothers who wish to withdraw from the study at any point during the research process will be removed from the study.
* did not complete the process of the assessment and intervention of this study.
18 Years
65 Years
FEMALE
Yes
Sponsors
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Amasya University
OTHER
Responsible Party
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Dilara AYDIN TOZLU
Research Asssistant, Nurse
Locations
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Amasya University
Amasya, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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13062025
Identifier Type: -
Identifier Source: org_study_id
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