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

Not Applicable

Not yet recruiting

• Conditions: Sudden Infant Death Syndrome; Shaken Baby Syndrome

• Registration Number: NCT07037914
• Lead Sponsor: Amasya University

Brief 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).

Detailed 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-13
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-01
• Primary Completion: 2026-07
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sudden Infant Death Syndrome Care Skills	at the end of the invervention program (8 weeks after from baseline)	Sudden Infant Death Syndrome Care Skills Form (SIDS-CSF) The SIDS-CSF was developed by the researchers to assess mothers' care skills related to Sudden Infant Death Syndrome (SIDS). The researchers created the SIDS-CSF based on a review of the relevant literature. The form consists of a total of 28 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Shaken Baby Syndrome Awareness	at the end of the invervention program (8 weeks after from baseline)	Shaken Baby Syndrome Awareness Assessment Scale - Short Form (SBS-AAS-SF) The scale consists of three dimensions: soothing techniques, discipline techniques, and potential injury. The items in the scale are designed to assess whether the actions of caregivers are appropriate within each of these three dimensions. The scale includes 12 items for each dimension, totaling 36 items, and is formatted as a 6-point Likert scale. The correlations between the scores of the subscales indicate the degree of linearity among the three dimensions. The scale scores provide insight into the interrelationships of the constructs associated with shaking a baby, offering information on how effective interventions should be structured.
Shaken Baby Syndrome Care Skills	at the end of the invervention program (8 weeks after from baseline)	Shaken Baby Syndrome Care Skills Form The SBS-CSF was developed by the researchers to assess mothers' care skills related to Shaken Baby Syndrome (SBS). The researchers created the SBS-CSF based on a review of the relevant literature. The form consists of a total of 13 items. It is structured as a 5-point Likert-type scale (Always, Frequently, Occasionally, Rarely, Never).
Sudden Infant Death Syndrome Awareness	at the end of the invervention program (8 weeks after from baseline)	Sudden Infant Death Syndrome Awareness Scale - Mother Form The scale consists of six items, divided into two sub-dimensions. These dimensions are 'Baby's Sleep Area' and 'Baby's Sleep Environment.' The scale uses a five-point Likert scale (Never = 1, Rarely = 2, Sometimes = 3, Often = 4, Always = 5). The last three questions of the scale are reverse-coded. The scale is interpreted based on the total scores of the subscales rather than the total score. As the score obtained from each subscale increases, it is interpreted that the level of awareness is also low. The Cronbach's alpha and McDonald's omega values for the 'Baby's Sleep Area' and 'Baby's Sleep Environment' subscales were found to be above 0.60.
Self-Efficacy	at the end of the invervention program (8 weeks after from baseline)	The Perceived Maternal Parenting Self-Efficacy Questionnaire The scale consists of 20 items and 4 subdimensions. It includes 18 positively worded items, rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The scale comprises three subfactors: "mother-infant interaction" (items 1, 2, 4, 5, 6, 7, 8, 13, 18), "caregiving procedures" (items 3, 14, 15, 16, 17), and "belief in the ability to foster positive infant behavior" (items 9, 10, 11, 12). Higher total scores indicate higher levels of maternal self-efficacy. A total score is obtained by summing the scores of all items.

Secondary Outcome Measures

Name	Time	Method
Sleep Environment	a home visit on the 15th day postpartum (2 weeks after from baseline)	Sleep Environment Checklist The Sleep Environment Checklist was developed by the researchers based on the relevant literature to assess mothers' care skills and compliance with safe sleep practices. The checklist consists of a total of 14 items.

Trial Locations

Locations (1)

Amasya University; 🇹🇷 Amasya, Turkey