Not Yet RecruitingNot Applicable

The Impact of the Nurse-Led "My Baby is Safe" Educational Program

Turkey (Türkiye)50 participantsStarted 2025-07

Plain-language summary

The aim of this study is to determine the effect of the My Baby is Safe Educational Program on mothers' knowledge, skills, and self-efficacy levels.The objectives of the study are to ensure that mothers acquire sufficient knowledge and skills regarding SIDS and SBS, and to enhance their self-efficacy levels.The participants were randomly assigned to one group that received only the My Baby is Safe Educational Program (Group I), or to another group that received standard care (Group II).

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18 years or older, * 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 whose newborns have any health problems will be excluded from the study. * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sudden Infant Death Syndrome Awareness

Timeframe: baseline (first assessment)

Sudden Infant Death Syndrome Awareness

Timeframe: at the end of the invervention program (8 weeks after from baseline)

Sudden Infant Death Syndrome Care Skills

Timeframe: baseline (first assessment)

Sudden Infant Death Syndrome Care Skills

Timeframe: a home visit on the 15th day postpartum (2 weeks after from baseline)

Sudden Infant Death Syndrome Care Skills

Timeframe: at the end of the invervention program (8 weeks after from baseline)

Shaken Baby Syndrome Awareness

Timeframe: baseline (first assessment)

Shaken Baby Syndrome Awareness

Timeframe: at the end of the invervention program (8 weeks after from baseline)

Trial details

NCT IDNCT07037914

SponsorAmasya University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Dilara Aydın Tozlu, MSc

05432013779 dilara.aydin@amasya.edu.tr

View on ClinicalTrials.gov More Sudden Infant Death Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Sudden Infant Death Syndrome Awareness

Timeframe: baseline (first assessment)

Sudden Infant Death Syndrome Awareness

Timeframe: at the end of the invervention program (8 weeks after from baseline)

Sudden Infant Death Syndrome Care Skills

Timeframe: baseline (first assessment)

Sudden Infant Death Syndrome Care Skills

Timeframe: a home visit on the 15th day postpartum (2 weeks after from baseline)

Sudden Infant Death Syndrome Care Skills

Timeframe: at the end of the invervention program (8 weeks after from baseline)

Shaken Baby Syndrome Awareness

Timeframe: baseline (first assessment)

Shaken Baby Syndrome Awareness

Timeframe: at the end of the invervention program (8 weeks after from baseline)