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

NCT ID: NCT06778993

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-04-01

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.

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Breastfeeding Education Program Accompanied by a Wearable (Hybrid) Simulator

Intervention Type: OTHER

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.

Controlled Group

There is no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Breastfeeding Education Program Accompanied by a Wearable (Hybrid) Simulator

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.

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Rasime Yıldırım Dugeroglu

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayten Şenturk Erenel

Role: STUDY_DIRECTOR

Lokman Hekim University

Locations

Private Obstetrics Clinics in Kırşehir Province

Kırşehir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Date 04.04.2023/decision no.07

Identifier Type: -

Identifier Source: org_study_id