- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06775444
Evaluation of the Effectiveness of a Breastfeeding Education Program Based on Planned Behavior Theory
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aylin Tozluoğlu
- Phone Number: +905424555336
- Email: aylinozluoglu@gmail.com
Study Contact Backup
- Name: Başak Demirtaş
- Phone Number: +90 312 319 5018
- Email: hicyilmaz@ankara.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intervention Group
In addition to the routine breastfeeding training in the hospital where the study was conducted, the intervention group will be given a 2-session "Breastfeeding Education Program Based on the Theory of Planned Behavior".
|
In addition to routine breastfeeding training at the hospital where the study is conducted, the intervention group will be given a 2-session Breastfeeding Training Program Based on Planned Behavior Theory. Education Content: The importance of breast milk, the benefits of breastfeeding, the dangers of artificial feeding, putting the baby to the breast, signs of hunger in the baby, the harms of bottle and pacifier, breastfeeding positions, breast-related problems, information sources about breastfeeding, birth and breastfeeding leave for working mothers, breastfeeding in the community, the importance of environmental and professional support during breastfeeding. Insufficient milk anxiety, increasing milk intake and production, situations where milk should be expressed, milk expression methods, storage conditions of breast milk, alternative feeding methods with expressed milk, methods to be applied to increase breast milk, differences between breast milk and formula milk. |
|
Sham Comparator: Control group
The control group will receive routine breastfeeding training at the hospital where the study is conducted.
|
The control group will receive routine breastfeeding education at the hospital where the study is conducted.
Routine breastfeeding education includes the importance of breast milk and breastfeeding (benefits of breast milk and breastfeeding, correct breastfeeding technique and breastfeeding positions, time for the first feeding of the newborn, feeding method, expressing and storing breast milk, techniques for giving expressed breast milk as close as possible to breastfeeding, harms of bottle use, breast problems and coping methods).
Pregnant women who give birth at the hospital where the study is conducted receive routine breastfeeding education from the breastfeeding nurse in the ward before being discharged.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Attrition Prediction Tool (BAPT)
Time Frame: 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
|
Breastfeeding Attrition Prediction Tool (BAPT) is a scale consisting of 90 questions on a 5-point Likert-type scale based on the theory of planned behavior.
There are four different sub-dimensions in the scale, which does not have a total score.
These are "Negative Breastfeeding Attitude", "Positive Breastfeeding Attitude", "Social and Professional Support" and "Breastfeeding Control" and each sub-scale is scored separately.
A high scale score indicates that the mother has high breastfeeding control.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Self-Efficacy Scale Short Form (Antenatal Breastfeeding Self-Efficacy Scale)
Time Frame: 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
|
A 14-item short form of the Breastfeeding Self-Efficacy Scale was created.
He stated that the short version of the Breastfeeding Self-Efficacy Scale could also be used during pregnancy by using the phrase "future tense" in its items.
The short form of the scale provides ease of application and accurately evaluates self-efficacy.
Cronbach's alpha value of the scale was found to be 0.94.
The scale was created on a five-point Likert type, where 1 = not at all sure and 5 = always sure.
A minimum of 14 and a maximum of 70 points can be obtained from the scale.
As the score increases, it means that breastfeeding self-efficacy increases
|
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
|
|
Breastfeeding Adaptation Scale (BFAS)
Time Frame: 7-14 days postpartum
|
The 27-item scale evaluates breastfeeding adaptation.
It has 8 sub-dimensions: emotional change between the mother and her baby (4 items), breastfeeding confidence (5 items), sufficient breast milk (3 items), baby's nutritional capacity and growth (4 items), familiarity with the baby (4 items), discomfort during breastfeeding (3 items), preservation of breast milk volume (2 items) and receiving social support (2 items).
It was developed on a 5-point Likert type scale, where 1=Strongly agree, 5=Strongly disagree.
A minimum of 27 and a maximum of 135 points can be obtained from the scale.
The higher the score obtained from the scale, the higher the breastfeeding adaptation.
|
7-14 days postpartum
|
|
Breastfeeding Motivation Scale (For Primiparous Mothers)
Time Frame: 1.Postpartum 7-14 days, 2. Postpartum 4-6 weeks, 3. Postpartum 4th month, 4. Postpartum 6th month
|
Breastfeeding motivation scale (For primiparous mothers) consists of 5 sub-dimensions and 23 items.
Scale items are graded from 1=I strongly disagree to 4=I strongly agree.
The scale is a 4-point Likert type, and each item is scored between 1-4.
There is no total score for the scale.
The scores of the sub-dimensions are calculated by taking the average of the scale sub-dimension scores.
As the score obtained from the scale sub-dimension increases, the motivation representing that sub-dimension also increases.
The Cronbach Alpha coefficient of the scale is 0.88.
|
1.Postpartum 7-14 days, 2. Postpartum 4-6 weeks, 3. Postpartum 4th month, 4. Postpartum 6th month
|
|
Breastfeeding Motivation Scale (For Multiparous Mothers)
Time Frame: 1.Postpartum 7-14 days, 2. Postpartum 4-6 weeks, 3. Postpartum 4th month, 4. Postpartum 6th month
|
Breastfeeding motivation scale (For Multiparous Mothers) consists of 6 sub-dimensions and 24 items.
The Cronbach alpha value of the scale is 0.914.
Scale items are graded from 1=I strongly disagree to 4=I strongly agree.
The scale is a 4-point Likert type, and each item is scored between 1-4.
There is no total score for the scale.
The scores of the sub-dimensions are calculated by taking the average of the scale sub-dimension scores.
As the score obtained from the scale sub-dimension increases, the motivation representing that sub-dimension also increases.
|
1.Postpartum 7-14 days, 2. Postpartum 4-6 weeks, 3. Postpartum 4th month, 4. Postpartum 6th month
|
|
Breastfeeding Tracking Form
Time Frame: 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
|
The "Breastfeeding Tracking Form" includes the baby's feeding style, breastfeeding frequency, giving additional food other than breast milk, problems with breastfeeding, desire to continue breastfeeding, doctor's evaluation of the baby's weight gain, daily urine amount, and a chart for tracking pacifier and bottle use in order to track the breastfeeding process after birth.
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Başak Demirtaş, Ankara University Faculty of Nursing Department of Nursing
- Study Chair: Aylin Tozluoğlu, Ankara University Health Sciences Institute PhD student
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AnkaraÜ-HF-AT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Feeding
-
London School of Hygiene and Tropical MedicineFHI 360; AFRICSante; Centre MurazCompleted
-
The Hong Kong Polytechnic UniversityCompletedParents | Breast Feeding, ExclusiveHong Kong
-
Loma Linda UniversityNot yet recruitingPregnancy Related | Breast Feeding, ExclusiveUnited States
-
University of FloridaCompleted
-
Emel GÜÇLÜ CİHANKahramanmaras Sutcu Imam UniversityRecruitingBreast Feeding | Primiparity | Exclusive Breast Feeding | Maternal-Fetal AttachmentTurkey (Türkiye)
-
Danone NutriciaCompletedBreast Feeding | Breast Milk ExpressionChina
-
University of TurkuCompleted
-
Sakarya UniversityNot yet recruitingBreast Feeding | Feeding BehaviorTurkey
-
University of Maryland, BaltimoreWithdrawnBreast Pumping | Human Milk/BreastfeedingUnited States
-
Cumhuriyet UniversityCumhuriyet University HospitalCompletedBreast-feeding | Kangaroo Care | Comfort in Neonates | Pain in NewbornsTurkey (Türkiye)
Clinical Trials on Breastfeeding Education Program Based on Planned Behavior Theory
-
Ankara UniversityNot yet recruitingDysmenorrhea PrimaryTurkey
-
Eskisehir Technical UniversityThe Scientific and Technological Research Council of TurkeyCompletedSedentary Lifestyle | Sedentary Behavior | Physical Activity LevelTurkey
-
University of the Basque Country (UPV/EHU)CompletedChildhood Obesity | Healthy Diet | Eating Behavior | Fruit and Vegetable Intake
-
Manish RajbanshiCompletedInternet Addiction Prevention Among Higher Secondary School StudentsNepal
-
Koç UniversityCompletedDiabetes Mellitus, GestationalTurkey
-
Izmir Katip Celebi UniversityCompletedAbsenteeism | Hand Hygiene | Respiratory Tract; Infection, Upper (Acute)Turkey
-
Istanbul University - Cerrahpasa (IUC)Unknown
-
Ankara Yildirim Beyazıt UniversityEnrolling by invitationPregnancy | Healthy Subjects | Breastfeeding | Hypno-breastfeeding Education | Healthy (Controls) | Breastfeeding Self-Efficacy | Information Motivation Behavioral Skills Model | Breastfeeding MotivationTurkey (Türkiye)
-
Ege UniversityNot yet recruitingOstomy | Mobile Application | Stoma
-
Sakarya UniversityRecruitingPaternal Involvement in Breastfeeding | Parental Support for BreastfeedingTurkey (Türkiye)