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

NCT07037914 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-06-26

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

OTHER

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.

Sponsors & Collaborators

  • Amasya University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2026-07-31
Completion
2026-08-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07037914 on ClinicalTrials.gov