Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Enrolling by invitation Not applicable

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

NCT06778993 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2023-11-01
Last updated
2025-03-14

Condition(s) studied

Breastfeeding

Investigational drug(s) / intervention(s)

Breastfeeding Education Program Accompanied by a Wearable (Hybrid) Simulator

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.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
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 outcome measure(s)

  • Introductory Information Form — 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 — 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 — 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 — 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.

Trial sites (1)

FacilityCityRegionStatus
Private Obstetrics Clinics in Kırşehir Province Kırşehir Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06778993 on ClinicalTrials.gov ↗ ← All trials in Turkey