PrematureTEACH-PRENCT07371845
Effect of Teach-Back Education on Breastfeeding and Bonding in Mothers of Preterm Infants
A study testing Teach-Back Education in people with Premature and Breast Feeding, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature, Breast Feeding, Mother-Child Relationship
- What is being tested?
- Teach-Back Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.),
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- 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.
Who cannot join
- All mothers who do not meet the inclusion criteria will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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".
- Conditions
- Premature, Breast Feeding, Mother-Child Relationship
- Being tested
- Teach-Back Education
- Keywords
- teach-back, preterm infant, breastfeeding success
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach-Back EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Teach-back Education Group | Experimental | Mothers receive teach-back education on breastfeeding and infant care. Receives: Behavioral: Teach-Back Education |
| Control Group | No intervention | Mothers receive routine care without teach-back education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Introduction Form
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.
Measured: First week
The Breastfeeding Self-Efficacy Scale for Mothers of Ill and/or Preterm Infants
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.
Measured: First Week
Mother-to-Infant Bonding Scale
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.
Measured: First Week
Secondary outcomes (3)
The Breastfeeding Self-Efficacy Scale for Mothers of Ill and/or Preterm Infants
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.
Measured: within the fist week
Mother-to-Infant Bonding Scale
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.
Measured: within the first week
Teach-Back Training Evaluation Form
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.
Measured: within the first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Dec 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be divided into two groups: an experimental group and a control group.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devran ATALAY ÖZKILIÇ, Ataturk University
- Investigators
- fatma güdücü tüfekci, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371845
- Sponsor's protocol ID
- ATATURKU-HF-DAÖ-02
- Acronym
- TEACH-PRE
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Teach-Back Education Given to Mothers of Preterm Infants on Breastfeeding Success and Mother-Infant Bonding: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07371845
- Acronym / sponsor ID
- TEACH-PRE / ATATURKU-HF-DAÖ-02
- Conditions
- Premature, Breast Feeding, Mother-Child Relationship
- Keywords
- teach-back, preterm infant, breastfeeding success
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be divided into two groups: an experimental group and a control group.
| Arm | Type | Receives |
|---|---|---|
| Teach-back Education Group | Experimental | Behavioral: Teach-Back EducationMothers receive teach-back education on breastfeeding and infant care. |
| Control Group | No intervention | –Mothers receive routine care without teach-back education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (1 listed)
- All mothers who do not meet the inclusion criteria will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teach-Back EducationA 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. | Behavioural | Teach-back Education Group |
Primary outcome
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.
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.
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.
3 secondary outcomes
The Breastfeeding Self-Efficacy Scale for Mothers of Ill and/or Preterm Infants
Time frame: within the fist week
Mother-to-Infant Bonding Scale
Time frame: within the first week
Teach-Back Training Evaluation Form
Time frame: within the first week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fatma güdücü tüfekci study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach-Back Education in people with Premature and Breast Feeding, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Introduction Form (time frame: First week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.