- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07371845
Effect of Teach-Back Education on Breastfeeding and Bonding in Mothers of Preterm Infants (TEACH-PRE)
The Effect of Teach-Back Education Given to Mothers of Preterm Infants on Breastfeeding Success and Mother-Infant Bonding: A Randomized Controlled Trial
The aim of this randomized controlled experimental study is to contribute to the standardization of nursing interventions for premature mothers and to establish a scientific basis for breastfeeding education models in our country. It also aims to evaluate the effects of the following: digital privacy literacy, children's autonomy, decision-making ability, and privacy awareness. The hypotheses of the study are as follows:
H₁: Mothers who received Teach-Back training have a higher level of breastfeeding self-efficacy.
H₂: Mothers who received Teach-Back training have a higher level of mother-infant bonding.
H₀: There is no significant difference between the groups.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be conducted with mothers of premature babies who meet the inclusion criteria at the state hospital located in Tatvan district, affiliated with the Bitlis Provincial Health Directorate. Participants will be assigned to two groups using simple random sampling:
- Experimental group: (Mothers who received Teach-Back training)
- Control group: (Mothers who received routine discharge education). Data will be collected using the "Participant Identification Form", "Breastfeeding Self-Efficacy Scale for Mothers of Preterm Babies", "Mother-Infant Bonding Scale" and "Teach-Back Training Evaluation Form".
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey (Türkiye)
- Atatürk Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being 18 years of age or older,
- Having a baby born before the 37th week of gestation (being a mother of a premature baby),
- Being able to read and understand Turkish,
- Having actually started breastfeeding,
- Having no hearing, visual, or cognitive communication impairment,
- Not having a diagnosed serious psychiatric illness (major depression, anxiety disorder, etc.),
- The baby not being in a serious clinical condition, not under palliative care or intensive life support,
- Not participating in another breastfeeding education or counseling program at the same time,
- Voluntarily agreeing to participate in the study.
Exclusion Criteria:
- All mothers who do not meet the inclusion criteria will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Teach-back Education Group
Mothers receive teach-back education on breastfeeding and infant care.
|
A structured teach-back education program is provided to mothers of preterm infants to improve breastfeeding practices and enhance mother-infant bonding.
Mothers are asked to repeat and demonstrate the information to confirm understanding.
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No Intervention: Control Group
Mothers receive routine care without teach-back education.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Introduction Form
Time Frame: First week
|
The form was prepared by the researcher in accordance with the literature to determine the sociodemographic (age, education level, income level, marital status, place of residence) and obstetric characteristics (number of pregnancies, mode of delivery, gestational age, birth weight, neonatal hospital stay, previous breastfeeding experience, etc.) of the mothers participating in the study.
The form was developed using research examining the relationships between breastfeeding self-efficacy, mother-infant bonding, and maternal characteristics.
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First week
|
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The Breastfeeding Self-Efficacy Scale for Mothers of Ill and/or Preterm Infants
Time Frame: First Week
|
This scale was developed by Wheeler and Dennis (2013) and adapted into Turkish by Aluş Tokat et al. (2020).
It is an 18-item scale with a 5-point Likert scale (1=Not sure at all, 2=Not sure at all, 3=Sometimes sure, 4= Sure, 5=Very sure).
The minimum score obtainable on the scale is 18, and the maximum is 90.
A higher score indicates high breastfeeding self-efficacy.
|
First Week
|
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Mother-to-Infant Bonding Scale
Time Frame: First Week
|
This scale was developed by Taylor et al. (2005), and its Turkish validity and reliability study was conducted by Aydemir-Karakulak (2009).
The scale consists of 8 items.
It uses a 4-point Likert scale (1 = none - 4 = very much).
Scores on the scale range from 0 to 24.
The Cronbach alpha coefficient was found to be 0.683.
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First Week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Breastfeeding Self-Efficacy Scale for Mothers of Ill and/or Preterm Infants
Time Frame: within the fist week
|
This scale was developed by Wheeler and Dennis (2013) and adapted into Turkish by Aluş Tokat et al. (2020).
It is an 18-item scale with a 5-point Likert scale (1=Not sure at all, 2=Not sure at all, 3=Sometimes sure, 4= Sure, 5=Very sure).
The minimum score obtainable on the scale is 18, and the maximum is 90.
A higher score indicates high breastfeeding self-efficacy.
|
within the fist week
|
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Mother-to-Infant Bonding Scale
Time Frame: within the first week
|
This scale was developed by Taylor et al. (2005), and its Turkish validity and reliability study was conducted by Aydemir-Karakulak (2009).
The scale consists of 8 items.
It uses a 4-point Likert scale (1 = none - 4 = very much).
Scores on the scale range from 0 to 24.
The Cronbach alpha coefficient was found to be 0.683.
|
within the first week
|
|
Teach-Back Training Evaluation Form
Time Frame: within the first week
|
This form was prepared by the researcher to observe the comprehensibility and learning level of the Teach-back training given to the experimental group.
The form evaluates the participant's ability to explain the information received in their own words, recall basic concepts, and express their application plan.
A short checklist consisting of five items is completed observationally at the end of each session with a score of 0-2 (insufficient-partially sufficient).
The form will only be used to monitor the quality of the training process.
This evaluation approach is consistent with international guidelines for monitoring the process accuracy of the teach-back method.
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within the first week
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: fatma güdücü tüfekci, Ataturk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATATURKU-HF-DAÖ-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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