Clinical trial NCT06778993: 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
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breastfeeding
Keywords: breastfeeding
wearable breast simulator
nursing
father
mother
Breastfeeding Self-Efficacy
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. The main questions it aims to answer are:

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Introductory Information Form
timeFrame: 34th-36th Weeks of Pregnancy, 38th-40th Weeks of Pregnancy, Postpartum Days 1-3, 1st Week, and 6th Week
measure: Short Form of the Antepartum-Postpartum Breastfeeding Self-Efficacy Scale
timeFrame: 34th-36th Weeks of Pregnancy, 38th-40th Weeks of Pregnancy, Postpartum Days 1-3, 1st Week, and 6th Week
measure: Father's Impact on Breastfeeding Scale
timeFrame: 34th-36th Weeks of Pregnancy, 38th-40th Weeks of Pregnancy, Postpartum Days 1-3, 1st Week, and 6th Week
measure: Perceived Partner Support Scale in the Early Postpartum Period
timeFrame: 34th-36th Weeks of Pregnancy, 38th-40th Weeks of Pregnancy, Postpartum Days 1-3, 1st Week, and 6th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Private Obstetrics Clinics in Kırşehir Province
Study officials:
affiliation: Lokman Hekim Üniversitesi
name: Ayten Şenturk Erenel
role: STUDY_DIRECTOR
References: