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Self-efficacy Scale for Mothers of Premature Babies

Primary Purpose

Baby Care

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
education
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Baby Care focused on measuring prematüre, mother, scale

Eligibility Criteria

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Inclusion Criteria: Mothers of premature babies whose babies were discharged from the Neonatal Intensive Care Unit (NICU) (training will be given immediately after the baby is discharged), Continuing prematurity of the baby according to the corrected age, Full-time care of the baby at home by the mother, Mothers can speak and understand Turkish, Voluntary written and verbal informed consent was obtained from the mothers. Exclusion Criteria: Being a term baby The mother has an ongoing psychological diagnosis, The mothers' unwillingness to continue working at any stage of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    providing education

    Arm Description

    There are two groups, training and non-training.

    Outcomes

    Primary Outcome Measures

    Infant care activities of mothers of premature infants will be evaluated with the Self-Efficacy Scale for Mothers of Premature Infants Based on Individualized Developmental Care.
    Implementing the Self-Efficacy Scale of Mothers of Premature Infants Based on Individualized Developmental Care

    Secondary Outcome Measures

    Infant care activities of mothers of premature infants will be evaluated with the Self-Efficacy Scale for Mothers of Premature Infants Based on Individualized Developmental Care.
    Implementing the Self-Efficacy Scale of Mothers of Premature Infants Based on Individualized Developmental Care

    Full Information

    First Posted
    April 10, 2023
    Last Updated
    September 1, 2023
    Sponsor
    Eskisehir Osmangazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05869019
    Brief Title
    Self-efficacy Scale for Mothers of Premature Babies
    Official Title
    Developing and Implementing the Self-Efficacy Scale of Mothers of Premature Infants Based on Individualized Developmental Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2024 (Anticipated)
    Study Completion Date
    November 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Eskisehir Osmangazi University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of this study is to develop a scale to determine the self-efficacy of mothers of premature infants in individualized developmental care practices. This study consists of two stages. In the first stage, it is planned to develop a scale to determine the self-efficacy levels of mothers of premature babies based on individualized developmental care. In the second stage, the scale will be applied. At this stage, families will be trained for individualized developmental care and the effectiveness of the education will be evaluated through the developed scale. For the first stage of the study, it is stated in the literature that at least 5 times the number of items should be taken in determining the sample size during the scale development stage, and 10 times in order to increase the reliability of the scale. In this study, after creating the scale items, a pilot application will be made with 3 mothers. Feedback will be received from mothers regarding the clarity of the questions and the scale will be finalized according to the feedback received. Then, the scale will be applied to the participant with a size of at least 10 times the number of scale items. For the second phase of the study, firstly, a preliminary application will be made with 10 mothers who meet the inclusion criteria and agree to participate in the study. The number of samples to be taken for the second stage of the research will be determined by performing power analysis with the findings obtained. Mothers included in the preliminary application will not be included in the study. It is planned to use stratified block randomization method in the study. First, mothers will be stratified according to their education level and the total number of children they have, then an equal number of (blocking) mothers will be assigned to each group. Data will be collected after obtaining written permission from the institution where the research will be conducted. "Descriptive Information Form", "Informed Voluntary Consent Form" prepared by the researchers and "Individualized Developmental Care Based Premature Baby Mothers' Self-Efficacy Scale" will be used in data collection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Baby Care
    Keywords
    prematüre, mother, scale

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    providing education
    Arm Type
    Experimental
    Arm Description
    There are two groups, training and non-training.
    Intervention Type
    Other
    Intervention Name(s)
    education
    Intervention Description
    Premature baby care training will be provided.
    Primary Outcome Measure Information:
    Title
    Infant care activities of mothers of premature infants will be evaluated with the Self-Efficacy Scale for Mothers of Premature Infants Based on Individualized Developmental Care.
    Description
    Implementing the Self-Efficacy Scale of Mothers of Premature Infants Based on Individualized Developmental Care
    Time Frame
    On the first day of the babies' discharge, face-to-face interviews will be provided with mothers.
    Secondary Outcome Measure Information:
    Title
    Infant care activities of mothers of premature infants will be evaluated with the Self-Efficacy Scale for Mothers of Premature Infants Based on Individualized Developmental Care.
    Description
    Implementing the Self-Efficacy Scale of Mothers of Premature Infants Based on Individualized Developmental Care
    Time Frame
    Face-to-face interviews will be provided with mothers 15 days after their babies are discharged from the premature intensive care unit.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    The study will be conducted with mothers of premature babies.
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Mothers of premature babies whose babies were discharged from the Neonatal Intensive Care Unit (NICU) (training will be given immediately after the baby is discharged), Continuing prematurity of the baby according to the corrected age, Full-time care of the baby at home by the mother, Mothers can speak and understand Turkish, Voluntary written and verbal informed consent was obtained from the mothers. Exclusion Criteria: Being a term baby The mother has an ongoing psychological diagnosis, The mothers' unwillingness to continue working at any stage of the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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