MothersNCT06277856
Peer Interaction of Primiparas Sharing a Room With Multiparas With Successful Breastfeeding Experience
A study of Mothers, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The World Health Organization (WHO) states that peer support breastfeeding education programs are effective interventions for improving breastfeeding outcomes. In this context, the WHO's Global Strategy for Infant and Young Child Feeding recommends the implementation of "lay health worker peer counselors" and… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mothers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2022to 26 Aug 2024
- 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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Under 18 years of age
- Non-literate in Turkish
- Has a psychiatrically diagnosed health problem
- Developing a health problem that may prevent breastfeeding
- Taking medication that may jeopardise breastfeeding
- Women who do not want to participate will not be included in the study.
Show all 10Show fewer
- Requesting a room change
- Not wanting to/wanting to stop peer interaction within the scope of the room arrangement
- After settling in the room, those who did not want to answer the data collection tools for any reason/left the data collection tools unfinished
- Mothers who could not be reached in the postnatal 1st month follow-up will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Peer Interaction on Breastfeeding Self-Efficacy of Primiparas Sharing the Same Room With Mothers With Successful Postpartum Breastfeeding Experience; Randomised Controlled Study
The World Health Organization (WHO) states that peer support breastfeeding education programs are effective interventions for improving breastfeeding outcomes. In this context, the WHO's Global Strategy for Infant and Young Child Feeding recommends the implementation of "lay health worker peer counselors" and "mother-to-mother support groups" to promote and support breastfeeding. The tenth step of the Baby-Friendly Hospital Initiative also emphasizes the importance of mother-to-mother support as a successful intervention for breastfeeding. However, in our country, there have been limited studies and efforts to provide peer education and support for breastfeeding. Although various valuable studies using different educational techniques have been conducted to improve breastfeeding rates, the integration of these programs into routine clinical practice remains insufficient. This study aims to implement a peer interactive education program in postpartum rooms to bring experienced and inexperienced mothers together, as part of the hospital routine. The project will focus on the development and implementation of a peer interactive education program and will investigate its impact on the breastfeeding self-efficacy of primiparous mothers. The research follows a two-group pre-test and post-test design, is non-blind, and uses randomized controlled methodology. Initially, the hospital rooms will be rearranged to accommodate the implementation of the peer support breastfeeding education module. Researcher midwives will provide a brief training to experienced peer educator mothers who have previously breastfed.Afterwards, the peer education program will be conducted when the experienced mother and primiparous mother are together in the room. The study emphasizes improving early postpartum breastfeeding success and aims to make peer interaction a routine part of hospital practice. The feasibility of implementing peer education in hospitals will be evaluated, considering its simplicity and practicality. The impact of peer interactions on the mother's breastfeeding self-efficacy and attitudes towards breastfeeding will be assessed.
Overall, this research aims to improve breastfeeding rates by implementing peer support programs in hospital settings and evaluating the outcomes of peer interactions in terms of the mother's breastfeeding self-efficacy and attitudes towards breastfeeding.
Read the detailed description
Study Design: This project was planned as a two-group, non-blinded randomised controlled trial.
Ethical approval was obtained from the Medical Research Ethics Committee of a university for the conduct of the study (Date: 08.11.2022, Decision no: 22-11T/25).
Population and Sample of the Study: Mothers who were hospitalised in Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital obstetrics and gynaecology ward, who met the inclusion criteria and volunteered to participate in the study will constitute the population of the study. A priori power analysis was performed using G.Power 3.1.9.2 package programme to determine the sample size. In the calculation made, with the assumption of 0.5 effect value for 80% power at 95% confidence interval, it was calculated as 128 women, 64 for the group in which peer supported breastfeeding education will be applied and 64 for the group in which standard education will be applied. In order to ensure homogeneity between the groups and to eliminate selection bias, the "block randomisation" method, one of the fixed probability randomisation methods, will be used in the study and women who meet the inclusion criteria will be distributed to the intervention and control groups.
Hypotheses of the study
- H1: Breastfeeding self-efficacy of mothers who receive peer interaction after birth will be higher than the control group.
- H1: The level of exclusive breastfeeding of mothers receiving peer interaction will be higher than that of mothers in the control group.
- Conditions
- Mothers
- Being tested
- Peer interaction/control
- Keywords
- Breastfeeding, Peer, interaction, Education, Hospital based, room
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer interaction/controlBehavioural
This study was planned as a randomised controlled study with a two-group pretest and posttest design.
| Study group | Role | What they receive |
|---|---|---|
| peer interaction | Experimental | The rooms will be arranged for two people and experienced and inexperienced mothers will be accommodated together. At a time when the mothers are available, the researcher will visit the mothers in their rooms, explain the purpose of the study and start the peer interaction session. In providing peer interaction, firstly, introductions will be made and the general condition of mothers and babies will be evaluated. The researcher will assess the breastfeeding status of the mothers and provide training on breastfeeding and breastfeeding. Receives: Behavioral: Peer interaction/control |
| control group | No intervention | Women in this group benefit from all routine postnatal care services of the hospital. Each mother is guided to breastfeeding by the breastfeeding counsellor and receives training. This group will also be given a brochure by the researcher, their breastfeeding status will be evaluated and if they have any questions, they will be answered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
breastfeeding self-efficacy
It will be evaluated using the Breastfeeding Self-Efficacy Scale-SF. The scale consists of a total of 14 items and is 5-point Likert type. The lowest score that can be obtained from the scale is 14 and the highest score is 70; it is stated that breastfeeding self-efficacy increases in mothers with high scores.
Measured: After the participant is admitted to the labour ward, the first application within 1 hour (before the peer support intervention); At the 24th hour after the peer support module; It will be applied 3 times in the 1st postpartum month.
exclusive breastfeeding rate
Exclusive breastfeeding is a physiological parameter. It will be evaluated according to the World Health Organisation classification system. Those who are exclusively breastfed, excluding ORS, drops, vitamins, minerals and medication will be grouped as "exclusively breastfed".
Measured: After the participant is admitted to the labour ward, the first application within 1 hour (before the peer support intervention); At the 24th hour after the peer support module; It will be applied 3 times in the 1st postpartum month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start18 Oct 2022
- Primary completion23 May 2023
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MothersStudies of the same condition, open and under way.
- More trials run by Ege 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYSUN EKŞİOĞLU, Ege University
- Investigators
- Aysun Eksioglu, Assoc Prof, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277856
- Sponsor's protocol ID
- Aysun Eksioglu
- Other IDs
- Ayse Akyar
- Status last verified
- Feb 2026
- First submitted
- 25 Dec 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When the study is completed, the study protocol and data can be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Peer Interaction on Breastfeeding Self-Efficacy of Primiparas Sharing the Same Room With Mothers With Successful Postpartum Breastfeeding Experience; Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06277856
- Acronym / sponsor ID
- Aysun Eksioglu
- Conditions
- Mothers
- Keywords
- Breastfeeding, Peer, interaction, Education, Hospital based, room
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 26 Feb 2024 (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 World Health Organization (WHO) states that peer support breastfeeding education programs are effective interventions for improving breastfeeding outcomes. In this context, the WHO's Global Strategy for Infant and Young Child Feeding recommends the implementation of "lay health worker peer counselors" and "mother-to-mother support groups" to promote and support breastfeeding. The tenth step of the Baby-Friendly Hospital Initiative also emphasizes the importance of mother-to-mother support as a successful intervention for breastfeeding. However, in our country, there have been limited studies and efforts to provide peer education and support for breastfeeding. Although various valuable studies using different educational techniques have been conducted to improve breastfeeding rates, the integration of these programs into routine clinical practice remains insufficient. This study aims to implement a peer interactive education program in postpartum rooms to bring experienced and inexperienced mothers together, as part of the hospital routine. The project will focus on the development and implementation of a peer interactive education program and will investigate its impact on the breastfeeding self-efficacy of primiparous mothers. The research follows a two-group pre-test and post-test design, is non-blind, and uses randomized controlled methodology. Initially, the hospital rooms will be rearranged to accommodate the implementation of the peer support breastfeeding education module. Researcher midwives will provide a brief training to experienced peer educator mothers who have previously breastfed.Afterwards, the peer education program will be conducted when the experienced mother and primiparous mother are together in the room. The study emphasizes improving early postpartum breastfeeding success and aims to make peer interaction a routine part of hospital practice. The feasibility of implementing peer education in hospitals will be evaluated, considering its simplicity and practicality. The impact of peer interactions on the mother's breastfeeding self-efficacy and attitudes towards breastfeeding will be assessed.
Overall, this research aims to improve breastfeeding rates by implementing peer support programs in hospital settings and evaluating the outcomes of peer interactions in terms of the mother's breastfeeding self-efficacy and attitudes towards breastfeeding.
Detailed description
Study Design: This project was planned as a two-group, non-blinded randomised controlled trial.
Ethical approval was obtained from the Medical Research Ethics Committee of a university for the conduct of the study (Date: 08.11.2022, Decision no: 22-11T/25).
Population and Sample of the Study: Mothers who were hospitalised in Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital obstetrics and gynaecology ward, who met the inclusion criteria and volunteered to participate in the study will constitute the population of the study. A priori power analysis was performed using G.Power 3.1.9.2 package programme to determine the sample size. In the calculation made, with the assumption of 0.5 effect value for 80% power at 95% confidence interval, it was calculated as 128 women, 64 for the group in which peer supported breastfeeding education will be applied and 64 for the group in which standard education will be applied. In order to ensure homogeneity between the groups and to eliminate selection bias, the "block randomisation" method, one of the fixed probability randomisation methods, will be used in the study and women who meet the inclusion criteria will be distributed to the intervention and control groups.
Hypotheses of the study
- H1: Breastfeeding self-efficacy of mothers who receive peer interaction after birth will be higher than the control group.
- H1: The level of exclusive breastfeeding of mothers receiving peer interaction will be higher than that of mothers in the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| peer interaction | Experimental | Behavioral: Peer interaction/controlThe rooms will be arranged for two people and experienced and inexperienced mothers will be accommodated together. At a time when the mothers are available, the researcher will visit the mothers in their rooms, explain the purpose of the study and start the peer interaction session. In providing peer interaction, firstly, introductions will be made and the general condition of mothers and babies will be evaluated. The researcher will assess the breastfeeding status of the mothers and provide training on breastfeeding and breastfeeding. |
| control group | No intervention | –Women in this group benefit from all routine postnatal care services of the hospital. Each mother is guided to breastfeeding by the breastfeeding counsellor and receives training. This group will also be given a brochure by the researcher, their breastfeeding status will be evaluated and if they have any questions, they will be answered. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Under 18 years of age
- Non-literate in Turkish
- Has a psychiatrically diagnosed health problem
- Developing a health problem that may prevent breastfeeding
- Taking medication that may jeopardise breastfeeding
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 |
|---|---|---|
| Peer interaction/controlThis study was planned as a randomised controlled study with a two-group pretest and posttest design. | Behavioural | peer interaction |
Primary outcome
breastfeeding self-efficacy
Time frame: After the participant is admitted to the labour ward, the first application within 1 hour (before the peer support intervention); At the 24th hour after the peer support module; It will be applied 3 times in the 1st postpartum month.
It will be evaluated using the Breastfeeding Self-Efficacy Scale-SF. The scale consists of a total of 14 items and is 5-point Likert type. The lowest score that can be obtained from the scale is 14 and the highest score is 70; it is stated that breastfeeding self-efficacy increases in mothers with high scores.
exclusive breastfeeding rate
Time frame: After the participant is admitted to the labour ward, the first application within 1 hour (before the peer support intervention); At the 24th hour after the peer support module; It will be applied 3 times in the 1st postpartum month.
Exclusive breastfeeding is a physiological parameter. It will be evaluated according to the World Health Organisation classification system. Those who are exclusively breastfed, excluding ORS, drops, vitamins, minerals and medication will be grouped as "exclusively breastfed".
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 19 Feb 2026.
- Individual participant dataSharing planned: Yes. When the study is completed, the study protocol and data can be shared with other researchers.
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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.
Aysun Eksioglu, Assoc Prof principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Mothers, run by Ege 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 0 inclusion and 10 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 19 Feb 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?
breastfeeding self-efficacy (time frame: After the participant is admitted to the labour ward, the first application within 1 hour (before the peer support intervention); At the 24th hour after the peer support module; It will be applied 3 times in the 1st postpartum month.). The study lists 2 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 19 Feb 2026.