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The Effect of Video-Assisted Sudden Infant Death Syndrome Prevention Training Program and Counseling Practice on Mothers' Knowledge Level and Self-efficacy: Randomized Controlled Study

Primary Purpose

Sudden Infant Death

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VASIDS-TP and Counseling Practice
Sponsored by
Dilara Aydin Tozlu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sudden Infant Death focused on measuring Sudden Infant Death Syndrome, Nursing, Parent Education, Educational Program, Prevention

Eligibility Criteria

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Inclusion Criteria: The one who has just given birth, With a healthy newborn baby, Speaks, understands and can read and write Turkish and has no barriers to communication, Able to use the internet, telephone and e-mail actively, Mothers who voluntarily agreed to participate in the study will be included. Exclusion Criteria: Have not attended at least 3 sessions of the training program, Mothers who indicate that they want to leave the study while the research is ongoing will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    VASIDS-TP and Counseling Practice

    Routine Care

    Arm Description

    Video-Assisted Sudden Infant Death Syndrome Prevention Training Program (VASIDS-TP) and Counseling Practice

    The control group will receive routine care in the obstetric ward. A pre-test will be conducted using the Google Survey form. "Personal Information Form", "Sudden Infant Death Syndrome Knowledge Level Assessment Form" (Pre-Test) and "General Self-Efficacy Scale" will be completed at this stage. The mothers in the control group will receive the training included in clinical routine care. The mothers in this group will not receive any planned structured training by the researchers during the study. The mothers in the control group will be administered the "Sudden Infant Death Syndrome Knowledge Level Assessment Data Form" and the "General Self-Efficacy Scale" with the Google survey that will be sent to their phones 1 month after the pre-test application. After the completion of the study, the control group will receive the same intervention (VASIDS-TP) as the intervention group.

    Outcomes

    Primary Outcome Measures

    Sudden Infant Death Syndrome Knowledge Level Assessment Form 1
    This form was developed by the researchers in line with the literature and consists of 33 items to measure the level of knowledge about SIDS.
    Sudden Infant Death Syndrome Knowledge Level Assessment Form 2
    This form was developed by the researchers in line with the literature and consists of 33 items to measure the level of knowledge about SIDS.
    General Self-Efficacy Scale 1
    "General Self-Efficacy Scale" is a five-point Likert-type scale consisting of 17 items. The question "How well does it describe you?" has five options ranging from "not at all" to "very well". The total score of the scale ranges between 17-85, and the higher the score, the higher the self-efficacy belief.
    General Self-Efficacy Scale 2
    "General Self-Efficacy Scale" is a five-point Likert-type scale consisting of 17 items. The question "How well does it describe you?" has five options ranging from "not at all" to "very well". The total score of the scale ranges between 17-85, and the higher the score, the higher the self-efficacy belief.

    Secondary Outcome Measures

    Personal Information Form
    The "Personal Information Form" developed by the researchers in line with the literature includes multiple-choice questions about mother, baby and sleep environment.
    DISCERN Scale
    The training videos developed by the researchers will be evaluated by experts using DISCERN. Basically, it was developed to assess the quality of written and technology-based educational materials prepared to inform individuals about health and treatment options. The DISCERN scale consists of 16 items and each question is scored from 1 to 5. A score in the range of 15-75 is obtained by summing the responses from each item. In the evaluation, a low total score indicates poor quality and a high score indicates good quality.
    System Usability Scale (SUS)
    In the test phase of the developed VASIDS-TP, SUS will be applied to evaluate the experiences of mothers (users). The whole scale consists of 10 questions. Each question has a value from 1 to 5 according to the answer given. SUS Score value is obtained between 0-100. SUS Score values of 68 points and above are considered above average, while values below 68 points are considered below average.

    Full Information

    First Posted
    April 8, 2023
    Last Updated
    April 8, 2023
    Sponsor
    Dilara Aydin Tozlu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05823051
    Brief Title
    The Effect of Video-Assisted Sudden Infant Death Syndrome Prevention Training Program and Counseling Practice on Mothers' Knowledge Level and Self-efficacy: Randomized Controlled Study
    Official Title
    Akdeniz University
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    October 15, 2023 (Anticipated)
    Study Completion Date
    November 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dilara Aydin Tozlu

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Sudden Infant Death Syndrome (SIDS) is one of the leading causes of infant mortality in the postneonatal period, but it can be prevented and its incidence can be reduced by creating a safe sleep environment with modifiable risk factors. It is known that parents, infant care providers and healthcare professionals do not have sufficient knowledge about SIDS and safe sleep, and especially mothers exhibit many risky behaviors in terms of SIDS, such as using the wrong sleeping positions while putting their babies to sleep. Therefore, it is of critical importance to inform and raise awareness of parents on the issues of SIDS and safe sleep, which remain important today, on the premise of promoting public health.
    Detailed Description
    Sudden Infant Death Syndrome (SIDS) is one of the leading causes of infant mortality in the postneonatal period, but it can be prevented and its incidence can be reduced by creating a safe sleep environment with modifiable risk factors. It is known that parents, infant care providers and health professionals do not have sufficient knowledge about SIDS and safe sleep, and especially mothers exhibit many risky behaviors in terms of SIDS, such as using the wrong sleeping positions while putting their babies to sleep. Therefore, it is of utmost importance to inform and raise awareness of parents on the issues of SIDS and safe sleep, which remain important today, on the premise of promoting public health. In addition, informing mothers about the risk factors to protect their babies from SIDS, encouraging them to create and maintain a safe sleep environment, and ensuring that they are pioneers in this regard are also of great importance in terms of sharing information with other infant care providers in their social life. SIDS occurs in the postpartum period and has high values in infant mortality rates. For this reason, it is predicted that awareness on this issue will be significantly increased by providing education to new mothers at the earliest period and that SIDS can be prevented significantly by providing safe sleep environments. At the same time, based on the effect of self-efficacy perceptions of new mothers on the care of the baby, it is thought that the training and counseling practice planned to be given to mothers about SIDS will have a positive effect on the self-efficacy perceptions of mothers. When the relevant literature was examined, it was found that there were not enough studies on this subject in our country. The aim of this study was to evaluate the effect of video-assisted Sudden Infant Death Syndrome prevention training program and counseling on mothers' knowledge level and self-efficacy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sudden Infant Death
    Keywords
    Sudden Infant Death Syndrome, Nursing, Parent Education, Educational Program, Prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study was planned as a randomized controlled, parallel, double centered and double blind study.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    As a randomization method, "simple randomization method" will be used to ensure an equal number of samples in the two groups and to prevent bias. In addition, during the data analysis phase, the database will be created by an academician independent of the researcher providing the training.
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    VASIDS-TP and Counseling Practice
    Arm Type
    Experimental
    Arm Description
    Video-Assisted Sudden Infant Death Syndrome Prevention Training Program (VASIDS-TP) and Counseling Practice
    Arm Title
    Routine Care
    Arm Type
    No Intervention
    Arm Description
    The control group will receive routine care in the obstetric ward. A pre-test will be conducted using the Google Survey form. "Personal Information Form", "Sudden Infant Death Syndrome Knowledge Level Assessment Form" (Pre-Test) and "General Self-Efficacy Scale" will be completed at this stage. The mothers in the control group will receive the training included in clinical routine care. The mothers in this group will not receive any planned structured training by the researchers during the study. The mothers in the control group will be administered the "Sudden Infant Death Syndrome Knowledge Level Assessment Data Form" and the "General Self-Efficacy Scale" with the Google survey that will be sent to their phones 1 month after the pre-test application. After the completion of the study, the control group will receive the same intervention (VASIDS-TP) as the intervention group.
    Intervention Type
    Other
    Intervention Name(s)
    VASIDS-TP and Counseling Practice
    Intervention Description
    VASIDS-TP will be implemented online as an individual training to the intervention group through the Microsoft Teams program, to be completed in 5 days-5 sessions in the time frames determined by the participants. The consultancy practice will start with a pre-test and participants will be assured that they can call the researcher 24/7, and the consultancy practice will be continued by phone call or messaging.
    Primary Outcome Measure Information:
    Title
    Sudden Infant Death Syndrome Knowledge Level Assessment Form 1
    Description
    This form was developed by the researchers in line with the literature and consists of 33 items to measure the level of knowledge about SIDS.
    Time Frame
    Before the training
    Title
    Sudden Infant Death Syndrome Knowledge Level Assessment Form 2
    Description
    This form was developed by the researchers in line with the literature and consists of 33 items to measure the level of knowledge about SIDS.
    Time Frame
    1 month after the training
    Title
    General Self-Efficacy Scale 1
    Description
    "General Self-Efficacy Scale" is a five-point Likert-type scale consisting of 17 items. The question "How well does it describe you?" has five options ranging from "not at all" to "very well". The total score of the scale ranges between 17-85, and the higher the score, the higher the self-efficacy belief.
    Time Frame
    Before the training
    Title
    General Self-Efficacy Scale 2
    Description
    "General Self-Efficacy Scale" is a five-point Likert-type scale consisting of 17 items. The question "How well does it describe you?" has five options ranging from "not at all" to "very well". The total score of the scale ranges between 17-85, and the higher the score, the higher the self-efficacy belief.
    Time Frame
    1 month after the training
    Secondary Outcome Measure Information:
    Title
    Personal Information Form
    Description
    The "Personal Information Form" developed by the researchers in line with the literature includes multiple-choice questions about mother, baby and sleep environment.
    Time Frame
    Before the training
    Title
    DISCERN Scale
    Description
    The training videos developed by the researchers will be evaluated by experts using DISCERN. Basically, it was developed to assess the quality of written and technology-based educational materials prepared to inform individuals about health and treatment options. The DISCERN scale consists of 16 items and each question is scored from 1 to 5. A score in the range of 15-75 is obtained by summing the responses from each item. In the evaluation, a low total score indicates poor quality and a high score indicates good quality.
    Time Frame
    After the training videos are created
    Title
    System Usability Scale (SUS)
    Description
    In the test phase of the developed VASIDS-TP, SUS will be applied to evaluate the experiences of mothers (users). The whole scale consists of 10 questions. Each question has a value from 1 to 5 according to the answer given. SUS Score value is obtained between 0-100. SUS Score values of 68 points and above are considered above average, while values below 68 points are considered below average.
    Time Frame
    Pre-application

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    women who have just given birth
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The one who has just given birth, With a healthy newborn baby, Speaks, understands and can read and write Turkish and has no barriers to communication, Able to use the internet, telephone and e-mail actively, Mothers who voluntarily agreed to participate in the study will be included. Exclusion Criteria: Have not attended at least 3 sessions of the training program, Mothers who indicate that they want to leave the study while the research is ongoing will be excluded.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dilara AYDIN TOZLU, Master's degree
    Email
    dilara.aydinn.da@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emine EFE, Professor
    Phone
    02423106103
    Email
    eefe@akdeniz.edu.tr

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28450082
    Citation
    Hutton JS, Gupta R, Gruber R, Berndsen J, DeWitt T, Ollberding NJ, Van Ginkel JB, Ammerman RT. Randomized Trial of a Children's Book Versus Brochures for Safe Sleep Knowledge and Adherence in a High-Risk Population. Acad Pediatr. 2017 Nov-Dec;17(8):879-886. doi: 10.1016/j.acap.2017.04.018. Epub 2017 Apr 24.
    Results Reference
    background

    Learn more about this trial

    The Effect of Video-Assisted Sudden Infant Death Syndrome Prevention Training Program and Counseling Practice on Mothers' Knowledge Level and Self-efficacy: Randomized Controlled Study

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