The Impact of the Nurse-Led "My Baby is Safe" Educational Program
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorAmasya University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 years or older,
Having a healthy newborn,
Having one or more children,
Having at least a primary school education,
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Education and Counseling
BehavioralThe 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.
Leaflet
Other interventionNo 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Experimental: Group I-Education and CounselingExperimental treatment 1 intervention
Group B: Control: Group II-LeafletOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline (first assessment)2
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.
Time frame
at the end of the invervention program (8 weeks after from baseline)3
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).
Time frame
baseline (first assessment)4
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).
Time frame
a home visit on the 15th day postpartum (2 weeks after from baseline)Secondary outcomes
1
Sleep Environment
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.
Time frame
a home visit on the 15th day postpartum (2 weeks after from baseline)Sponsors and contacts
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Source ClinicalTrials.gov
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