Clinical trial NCT06775444: Evaluation of the Effectiveness of a Breastfeeding Education Program Based on Planned Behavior Theory
Official title: The Effect Of The Theory Of Planned Behavior Based Breastfeeding Education Program Given To Pregnant Women On Breastfeedıng Adaptation, Motivation, Self-Efficacy And The Tendency To Early Weaning.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Feeding
Keywords: Theory Of Planned Behavior
Breastfeeding
Self Efficacy
Motivation
Breastfeeding Adaptation
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research was planned to be conducted as a single-center, parallel group, randomized controlled experimental, prospective study in a pre-test-post-test design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the research is to examine the effect of a breastfeeding training program based on the theory of planned behavior on Pregnant Womens' Breastfeeding Adaptation, Motivation, Self-Efficacy And The Tendency To Early Weaning.

Detailed description: The aim of the study is to examine the effects of a breastfeeding education program based on the theory of planned behavior on breastfeeding adaptation, motivation, self-efficacy, and the tendency to stop breastfeeding.

The study was planned to be conducted as a single-center, parallel group, randomized controlled experimental, prospective study in a pretest-posttest design.

The study was planned to be conducted in the pregnancy school/breastfeeding counseling polyclinic of Düzce Atatürk State Hospital. The sample of the study will consist of pregnant women in the last trimester who meet the inclusion criteria. Considering the losses that may occur during the study process, it is planned to continue the study with a total of 88 pregnant women.

The data of the study will be collected from the patient based on the "Introductory Information Form", "Information Form Regarding Birth and Breastfeeding Process", "Breastfeeding Adaptation Scale", "Breastfeeding Motivation Scale (For Primiparous Mothers)", "Breastfeeding Motivation Scale (For Multiparous Mothers)", "Antenatal Breastfeeding Self-Efficacy Scale-Short Form", "Breastfeeding Self-Efficacy Scale-Short Form", "Breastfeeding Discontinuity Scale" and "Breastfeeding Follow-up Form".

In the study, the "Breastfeeding Education Program Based on Planned Behavior Theory" consisting of 2 sessions will be applied to the intervention group, while the routine breastfeeding education in the hospital where the study is conducted will be applied to the control group. The breastfeeding process will be followed for 6 months after birth in both groups.

In the analysis of the study, it is planned to analyze descriptive statistics (number, percentage, mean and standard deviation), significance test of the difference between two means in independent groups (t test), t test in dependent groups, multi-way and one-way variance analysis in repeated measurements, Pearson correlation analyses for the relationships between the dimensions determining the scale levels, and the chi-square homogeneity test for whether the intervention and control groups are homogeneous in terms of characteristics.

Eligibility criteria: Inclusion Criteria:

* Those who are over 18 years old
* Pregnant women in their last trimester (pregnant women who are 27 weeks or more)
* Those who receive breastfeeding training at the Pregnancy School
* Speak and understand Turkish
* Do not have a risky pregnancy diagnosis
* Do not have multiple pregnancies
* Do not have a psychiatric or neurological disease that will affect their cognitive functions
* Have the WhatsApp application on their phone
* Volunteer to participate in the research
* Want to breastfeed their baby
* Have given birth at \>37 weeks of pregnancy
* Have a baby weighing at least 2500 grams
* Have a single healthy baby in the postpartum period
* Mothers who do not have breast problems that prevent breastfeeding, do not use medication that passes into breast milk, or have any disease (such as active tuberculosis, HIV) were determined as follows.

Exclusion Criteria:

* Those who could not continue the study for any reason
* Those who did not participate in all final tests
* Those who did not participate in all training
* Those who could not be reached more than 5 times in each planned telephone/face-to-face meeting.
* Those whose babies were hospitalized in neonatal intensive care after birth (except for babies hospitalized for more than 24 hours - due to neonatal jaundice)

Primary outcomes:
measure: Breastfeeding Attrition Prediction Tool (BAPT)
timeFrame: Pre-test application after routine breastfeeding education, Post-test application after the Breastfeeding Education Program Based on Planned Behavior Theory, 7-14 days postpartum, 4-6 weeks postpartum, 4th month postpartum, Postpartum 6th month
Secondary outcomes:
measure: Breastfeeding Self-Efficacy Scale Short Form (Antenatal Breastfeeding Self-Efficacy Scale)
timeFrame: 1. A pre-test will be applied before the Breastfeeding Education Program Based on Planned Behavior Theory. 2. Postpartum 7-14 days 3. Postpartum 4-6 weeks 4. Postpartum 4th month 5. Postpartum 6th month
measure: Breastfeeding Adaptation Scale (BFAS)
timeFrame: 7-14 days postpartum
measure: Breastfeeding Motivation Scale (For Primiparous Mothers)
timeFrame: 1.Postpartum 7-14 days, 2. Postpartum 4-6 weeks, 3. Postpartum 4th month, 4. Postpartum 6th month
measure: Breastfeeding Motivation Scale (For Multiparous Mothers)
timeFrame: 1.Postpartum 7-14 days, 2. Postpartum 4-6 weeks, 3. Postpartum 4th month, 4. Postpartum 6th month
measure: Breastfeeding Tracking Form
timeFrame: 1. The first 48 hours after birth, 2.Postpartum 7-14 days, 3. Postpartum 4-6 weeks, 4. Postpartum 4th month, 5. Postpartum 6th month
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University Faculty of Nursing Department of Nursing
name: Başak Demirtaş
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University Health Sciences Institute PhD student
name: Aylin Tozluoğlu
role: STUDY_CHAIR
References: