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

NCT07037914 | Not Yet Recruiting DMC

• 1 other identifier: 13062025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Sudden Infant Death Syndrome; Shaken Baby Syndrome

Keywords

Sudden Infant Death Syndrome; Shaken Baby Syndrome; Safe Sleep; Pediatric Nursing; Education

Outcome Measures

Primary Outcomes (12)

• Sudden Infant Death Syndrome Awareness

  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.

  baseline (first assessment)

• Sudden Infant Death Syndrome Awareness

  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.

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

• Sudden Infant Death Syndrome Care Skills

  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).

  baseline (first assessment)

• Sudden Infant Death Syndrome Care Skills

  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).

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

• Sudden Infant Death Syndrome Care Skills

  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).

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

• Shaken Baby Syndrome Awareness

  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.

  baseline (first assessment)

• Shaken Baby Syndrome Awareness

  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.

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

• Shaken Baby Syndrome Care Skills

  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).

  baseline (first assessment)

• Shaken Baby Syndrome Care Skills

  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).

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

• Shaken Baby Syndrome Care Skills

  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).

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

• Self-Efficacy

  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.

  baseline (first assessment)

• Self-Efficacy

  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.

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

Secondary Outcomes (1)

• Sleep Environment

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

Study Arms (2)

Experimental: Group I-Education and Counseling

EXPERIMENTAL

Behavioral: Education and Counseling

Control: Group II-Leaflet

OTHER

Other: Leaflet

Interventions

Education and Counseling BEHAVIORAL

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.

Experimental: Group I-Education and Counseling

Leaflet OTHER

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.

Control: Group II-Leaflet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amasya University: lead

Study Sites (1)

Amasya University

Amasya, 05000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sudden Infant Death; Shaken Baby Syndrome

Interventions

Educational Status; Counseling

Condition Hierarchy (Ancestors)

Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant Death; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Dilara Aydın Tozlu, MSc

CONTACT

05432013779; dilara.aydin@amasya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Asssistant, Nurse

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 26, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)