BreastfeedingNCT06778993

Using a Wearable Breast Simulator Breastfeeding Education Provided to Pregnant Women and Their Wives Mothers' Perceived Partner Support, Breastfeeding Self-Efficacy and Determining the Influence of Fathers on Breastfeeding

A study testing Breastfeeding Education Program Accompanied by a Wearable (Hybrid) Simulator in people with Breastfeeding, run by Gazi University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

The goal of this clinical trial is to evaluate the impact of breastfeeding education using a wearable breast simulator on perceived spousal support, breastfeeding self-efficacy, and breastfeeding outcomes in pregnant women and their spouses. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Breastfeeding
What is being tested?: Breastfeeding Education Program Accompanied by a Wearable (Hybrid) Simulator
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Nov 2023to 1 Apr 2025
Phase: Interventional
Are there results?: Not yet: the study is under way

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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

The expectant mother has a contraindicated condition for breastfeeding, The mother has a mental disability or a severe psychiatric disorder, The expectant mother has not received planned, professional breastfeeding education with her partner during pregnancy, The mother has communication issues.

Who cannot join

The newborn has a health issue that prevents breastfeeding, During the follow-up process of the study, the couple cannot be reached for any reason using the communication information provided, Premature birth (before the 37th week of pregnancy), A situation arises post-birth that prevents the mother, father, and baby from being together, The newborn has a health condition that hinders or negatively affects breastfeeding, The death of the mother and/or father, The development of a health issue in the mother that could prevent breastfeeding (such as breast cancer, severe heart disease), Participants choosing to withdraw from the study voluntarily.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site

Private Obstetrics Clinics in Kırşehir Province
Kırşehir

Other trials in Turkey (Türkiye)

About this study

Does education with a wearable breast simulator improve mothers' breastfeeding self-efficacy and perceived spousal support compared to standard education? Does this intervention positively influence fathers' involvement in breastfeeding and overall breastfeeding outcomes? Researchers will compare participants receiving the wearable simulator-based breastfeeding education to those receiving standard care to determine its effects on these outcomes.

Participants will:

Complete demographic and pre-test questionnaires, including breastfeeding self-efficacy and spousal support scales.

Attend two 25-minute theoretical and two 25-minute simulation-based training sessions using a wearable breast simulator.

Fathers will practice breastfeeding techniques, including baby positioning and milk expression, with the simulator.

Postpartum, participants will be assessed at the hospital and during follow-ups at home (1st and 6th weeks) for changes in perceived spousal support, breastfeeding self-efficacy, and fathers' involvement in breastfeeding.

Read the detailed description

Breastfeeding Education Given to Pregnant Women and Their Partners Using a Wearable Breast Simulator on Mothers' Perceived Spousal Support, Breastfeeding Self-Efficacy and Fathers' Breastfeeding. In this training, it is planned to provide training and implementation to pregnant women and their partners who have no previous breastfeeding experience .

The training is given theoretically to mothers and fathers, and the fathers-to-be are also given some practical experience and are made to wear a simulator.

In the study, women;

Their perceived spousal support is high,
Only the mother networks have a long data delivery time,
Having a high level of breastfeeding self-efficacy,
The aim is to have a positive effect on fathers' breastfeeding. Purpose of the research The aim of this study is to evaluate the effects of breastfeeding education provided during the prenatal period by wearing the breast on mother and father days, on perceived spousal support, the effect of breastfeeding on fathers' breastfeeding, and the reproductive effects of breastfeeding in the postnatal period.

Data Collection: The implementation will commence in the clinic by the researcher with the administration of an introductory form to couples in their 34th-36th weeks of pregnancy. Subsequently, based on the groups, participants will either receive breastfeeding education using a simulator or proceed without intervention. The process will continue during the 38th-40th weeks of pregnancy at the hospital, followed by postpartum home visits on days 1-3, and in the 1st and 6th weeks. During these visits, the monitoring form and the designated scales will be administered face-to-face by the researcher.

Conditions: Breastfeeding
Being tested: Breastfeeding Education Program Accompanied by a Wearable (Hybrid) Simulator
Keywords: breastfeeding, wearable breast simulator, nursing, father, mother, Breastfeeding Self-Efficacy
Medical subject headings: Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Breastfeeding Education Program Accompanied by a Wearable (Hybrid) SimulatorOther
This training is conducted in both theoretical and practical formats. The theoretical training consists of two sessions, each lasting 25 minutes, with a 10-minute break in between, totaling 60 minutes. Following the theoretical training, simulation-based skill training is conducted. This phase also comprises two sessions of 25 minutes each, with a 10-minute break, making a total duration of 60 minutes.

Study groups in NCT06778993
Study group	Role	What they receive
Intervention Group	Experimental	The implementation will begin in the clinic, where the researcher will administer an introductory form to couples in their 34th-36th weeks of pregnancy. Depending on the group assignments, participants will either receive breastfeeding education with a simulator or proceed without intervention. The process will continue in the hospital during the 38th-40th weeks of pregnancy, followed by postpartum visits on days 1-3 at participants' homes. Further monitoring will be conducted during the 1st and 6th weeks postpartum at their homes. The monitoring form and the designated scales will be completed face-to-face by the researcher during these visits. Receives: Other: Breastfeeding Education Program Accompanied by a Wearable (Hybrid) Simulator
Controlled Group	No intervention	There is no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Introductory Information Form
To determine the characteristics to be utilized in the study, the researcher prepared two separate introductory forms for mothers and fathers by reviewing the relevant literature.
The mother's introductory form includes sections on the sociodemographic characteristics of the expectant mother, information related to pregnancy, breastfeeding, and breast milk, as well as postpartum-specific details, including sections on the mother's characteristics during the 1st to 6th weeks postpartum.
The father's introductory form covers the sociodemographic characteristics of the expectant father, his knowledge and perspectives regarding pregnancy and the breastfeeding process, the father's relationship with the mother and baby during the postpartum period, and the father-baby relationship during the 1st to 6th weeks postpartum.
Measured: 34th-36th Weeks of Pregnancy, 38th-40th Weeks of Pregnancy, Postpartum Days 1-3, 1st Week, and 6th Week
Short Form of the Antepartum-Postpartum Breastfeeding Self-Efficacy Scale
The Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Initially, it was applied to 130 English-speaking Canadian women, yielding a Cronbach's alpha value of 0.96, with 73% of the items having item-total correlations ranging from 0.30 to 0.70. In 2003, Dennis revised the scale, reducing it to a 14-item version, creating the Short Form of the Breastfeeding Self-Efficacy Scale. The short form is a 5-point Likert scale, with responses ranging from 1 ("Not sure at all") to 5 ("Always sure"). AThe minimum score obtainable is 14, and the maximum score is 70. A higher score indicates higher breastfeeding self-efficacy.
Measured: 34th-36th Weeks of Pregnancy, 38th-40th Weeks of Pregnancy, Postpartum Days 1-3, 1st Week, and 6th Week
Father's Impact on Breastfeeding Scale
The Father's Impact on Breastfeeding Scale, consisting of 37 items, evaluates how frequently fathers engage in activities while the mother is breastfeeding, using a Likert-type rating scale from 1 to 5. Each item is scored on a 5-point Likert scale, where 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Very Often. The scale contains five subdimensions: understanding breastfeeding, assistance, appreciation, availability, and sensitivity.A higher total score on the scale indicates a greater impact of fathers on breastfeeding. The minimum score that can be obtained from the scale is 37, while the maximum score is 185.
Measured: 34th-36th Weeks of Pregnancy, 38th-40th Weeks of Pregnancy, Postpartum Days 1-3, 1st Week, and 6th Week
Perceived Partner Support Scale in the Early Postpartum Period
The Perceived Partner Support Scale in the Early Postpartum Period, developed in a 5-point Likert format, aims to determine the level of perceived partner support during the early postpartum period. The scale contains both positive and negative statements mixed together. The positive items are 1, 2, 3, 4, 5, 6, 7, 11, 13, and 16, while the negative items are 8, 9, 10, 12, 14, and 15.The highest possible score on the scale is 80, and the lowest possible score is 16.
Measured: 34th-36th Weeks of Pregnancy, 38th-40th Weeks of Pregnancy, Postpartum Days 1-3, 1st Week, and 6th Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20231 Apr 2025

First posted16 Jan 2025
Study start1 Nov 2023
Primary completion24 Mar 2025 (estimated)
Study completion1 Apr 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for BreastfeedingStudies of the same condition, open and under way.
More trials run by Gazi 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: Participant
Enrolment: 54 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06778993
Sponsor's protocol ID: Date 04.04.2023/decision no.07
Status last verified: Mar 2025
First submitted: 12 Jan 2025
Last updated: 14 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding

All Breastfeeding trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using a Wearable Breast Simulator Breastfeeding Education Provided to Pregnant Women and Their Wives Mothers' Perceived Partner Support, Breastfeeding Self-Efficacy and Determining the Influence of Fathers on Breastfeeding
ClinicalTrials.gov ID: NCT06778993
Acronym / sponsor ID: Date 04.04.2023/decision no.07
Conditions: Breastfeeding
Keywords: breastfeeding, wearable breast simulator, nursing, father, mother, Breastfeeding Self-Efficacy
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 54 participants (estimated)
Lead sponsor: Gazi UniversityUniversity, hospital or other
Study start: 1 Nov 2023 (actual)
Primary completion: 24 Mar 2025 (estimated)
Study completion: 1 Apr 2025 (estimated)
First posted: 16 Jan 2025 (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.

Participants will:

Complete demographic and pre-test questionnaires, including breastfeeding self-efficacy and spousal support scales.

Attend two 25-minute theoretical and two 25-minute simulation-based training sessions using a wearable breast simulator.

Fathers will practice breastfeeding techniques, including baby positioning and milk expression, with the simulator.

Detailed description

The training is given theoretically to mothers and fathers, and the fathers-to-be are also given some practical experience and are made to wear a simulator.

In the study, women;

Their perceived spousal support is high,
Only the mother networks have a long data delivery time,
Having a high level of breastfeeding self-efficacy,
The aim is to have a positive effect on fathers' breastfeeding. Purpose of the research The aim of this study is to evaluate the effects of breastfeeding education provided during the prenatal period by wearing the breast on mother and father days, on perceived spousal support, the effect of breastfeeding on fathers' breastfeeding, and the reproductive effects of breastfeeding in the postnatal period.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Intervention Group	Experimental	Other: Breastfeeding Education Program Accompanied by a Wearable (Hybrid) SimulatorThe implementation will begin in the clinic, where the researcher will administer an introductory form to couples in their 34th-36th weeks of pregnancy. Depending on the group assignments, participants will either receive breastfeeding education with a simulator or proceed without intervention. The process will continue in the hospital during the 38th-40th weeks of pregnancy, followed by postpartum visits on days 1-3 at participants' homes. Further monitoring will be conducted during the 1st and 6th weeks postpartum at their homes. The monitoring form and the designated scales will be completed face-to-face by the researcher during these visits.
Controlled Group	No intervention	–There is no intervention.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

The expectant mother has a contraindicated condition for breastfeeding, The mother has a mental disability or a severe psychiatric disorder, The expectant mother has not received planned, professional breastfeeding education with her partner during pregnancy, The mother has communication issues.

Key exclusion criteria (1 listed)

The newborn has a health issue that prevents breastfeeding, During the follow-up process of the study, the couple cannot be reached for any reason using the communication information provided, Premature birth (before the 37th week of pregnancy), A situation arises post-birth that prevents the mother, father, and baby from being together, The newborn has a health condition that hinders or negatively affects breastfeeding, The death of the mother and/or father, The development of a health issue in the mother that could prevent breastfeeding (such as breast cancer, severe heart disease), Participants choosing to withdraw from the study voluntarily.

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
Breastfeeding Education Program Accompanied by a Wearable (Hybrid) SimulatorThis training is conducted in both theoretical and practical formats. The theoretical training consists of two sessions, each lasting 25 minutes, with a 10-minute break in between, totaling 60 minutes. Following the theoretical training, simulation-based skill training is conducted. This phase also comprises two sessions of 25 minutes each, with a 10-minute break, making a total duration of 60 minutes.	Other	Intervention Group

Primary outcome

Introductory Information Form
Time frame: 34th-36th Weeks of Pregnancy, 38th-40th Weeks of Pregnancy, Postpartum Days 1-3, 1st Week, and 6th Week
To determine the characteristics to be utilized in the study, the researcher prepared two separate introductory forms for mothers and fathers by reviewing the relevant literature. The mother's introductory form includes sections on the sociodemographic characteristics of the expectant mother, information related to pregnancy, breastfeeding, and breast milk, as well as postpartum-specific details, including sections on the mother's characteristics during the 1st to 6th weeks postpartum. The father's introductory form covers the sociodemographic characteristics of the expectant father, his knowledge and perspectives regarding pregnancy and the breastfeeding process, the father's relationship with the mother and baby during the postpartum period, and the father-baby relationship during the 1st to 6th weeks postpartum.
Short Form of the Antepartum-Postpartum Breastfeeding Self-Efficacy Scale
Time frame: 34th-36th Weeks of Pregnancy, 38th-40th Weeks of Pregnancy, Postpartum Days 1-3, 1st Week, and 6th Week
The Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Initially, it was applied to 130 English-speaking Canadian women, yielding a Cronbach's alpha value of 0.96, with 73% of the items having item-total correlations ranging from 0.30 to 0.70. In 2003, Dennis revised the scale, reducing it to a 14-item version, creating the Short Form of the Breastfeeding Self-Efficacy Scale. The short form is a 5-point Likert scale, with responses ranging from 1 ("Not sure at all") to 5 ("Always sure"). AThe minimum score obtainable is 14, and the maximum score is 70. A higher score indicates higher breastfeeding self-efficacy.
Father's Impact on Breastfeeding Scale
Time frame: 34th-36th Weeks of Pregnancy, 38th-40th Weeks of Pregnancy, Postpartum Days 1-3, 1st Week, and 6th Week
The Father's Impact on Breastfeeding Scale, consisting of 37 items, evaluates how frequently fathers engage in activities while the mother is breastfeeding, using a Likert-type rating scale from 1 to 5. Each item is scored on a 5-point Likert scale, where 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Very Often. The scale contains five subdimensions: understanding breastfeeding, assistance, appreciation, availability, and sensitivity.A higher total score on the scale indicates a greater impact of fathers on breastfeeding. The minimum score that can be obtained from the scale is 37, while the maximum score is 185.
Perceived Partner Support Scale in the Early Postpartum Period
Time frame: 34th-36th Weeks of Pregnancy, 38th-40th Weeks of Pregnancy, Postpartum Days 1-3, 1st Week, and 6th Week
The Perceived Partner Support Scale in the Early Postpartum Period, developed in a 5-point Likert format, aims to determine the level of perceived partner support during the early postpartum period. The scale contains both positive and negative statements mixed together. The positive items are 1, 2, 3, 4, 5, 6, 7, 11, 13, and 16, while the negative items are 8, 9, 10, 12, 14, and 15.The highest possible score on the scale is 80, and the lowest possible score is 16.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
Individual participant dataSharing planned: No

Related trials for Breastfeeding

RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding

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.

Ayten Şenturk Erenel study director

Lokman Hekim 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 Breastfeeding Education Program Accompanied by a Wearable (Hybrid) Simulator in people with Breastfeeding, run by Gazi 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 1 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: enrolling by invitation, as of the sponsor's last update on 14 Mar 2025. 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?

This study is still under way. Results are not available in the source record yet.

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?

Introductory Information Form (time frame: 34th-36th Weeks of Pregnancy, 38th-40th Weeks of Pregnancy, Postpartum Days 1-3, 1st Week, and 6th Week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06778993.

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 14 Mar 2025.