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

A

Amasya University

Status

Not yet enrolling

Conditions

Shaken Baby Syndrome
Sudden Infant Death Syndrome

Treatments

Behavioral: Education and Counseling
Other: Leaflet

Study type

Interventional

Funder types

Other

Identifiers

NCT07037914
13062025

Details and patient eligibility

About

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).

Full description

The aim of this randomized controlled study was to determine the effectiveness of the My Baby is Safe Educational Program on mothers' knowledge, skills, and self-efficacy related to the prevention of Sudden Infant Death Syndrome (SIDS) and Shaken Baby Syndrome (SBS).

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.

Enrollment

50 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Experimental: Group I-Education and Counseling
Experimental group
Treatment:
Behavioral: Education and Counseling
Control: Group II-Leaflet
Other group
Treatment:
Other: Leaflet

Trial contacts and locations

1

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Central trial contact

Dilara Aydın Tozlu, MSc

Data sourced from clinicaltrials.gov

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