- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06341140
The Effect of Breastfeeding Support on Exclusive Breastfeeding, Occurrence of Breast Problems and Breastfeeding Self-Efficacy
March 25, 2024 updated by: Seçil Köken Durgun, Celal Bayar University
Does Individualized Breastfeeding Support Make a Difference in Exclusive Breastfeeding, Breast Problem Occurrence, and Breastfeeding Self-Efficacy in the First 6 Months: Randomized Controlled Study
The aim of the study is to determine the effect of individual breastfeeding support on the lactation process.
The research is a randomized controlled experimental study.
The sample of the study consisted of pregnant women who applied to the Obstetrics Polyclinic of a university hospital (intervention=51, control=51).
In the study, individual breastfeeding education was given to the intervention group during the antenatal period, and a training booklet was given to the control group.
In the postpartum period, home visits and phone follow-ups were carried out for both groups between the fifth day and the sixth month.
The effect of breastfeeding counseling on the lactation process; The duration of exclusive breastfeeding, breast problems and breastfeeding success was evaluated with.
The data of the study were collected using the Pregnant, Postpartum-Newborn Information Form, Breastfeeding Questionnaire, Breast Problems Diagnosis Form, LATCH Breastfeeding Diagnostic Tool and Breastfeeding Self-Efficacy Scale.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Manisa, Turkey
- Manisa Celal Bayar University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
İnclusion Criteria:
- Open communication and collaboration
- Over 18 years of age
- Having a singleton pregnancy
- Never given birth,
- At least in the 35th week of gestation,
- Residing in Manisa Central districts (Yunusemre and Şehzadeler),
- There is no maternal obstacle that would affect breastfeeding,
- Having no vision or hearing problems,
- Those who are willing to participate in the study
Exclusion Criteria:
- At the beginning of the research;
- Under 18 years of age,
- Having a risky pregnancy,
- Having breastfeeding experience,
- Less than the 35th gestational week,
- Residing outside Manisa Central districts (Yunusemre and Şehzadeler),
- Any maternal disability that may affect breastfeeding,
- Pregnant women who did not want to participate in the study were excluded.
During the research process;
- Those who want to leave the job,
- If the baby has any obstacle that may affect breastfeeding (presence of anomaly, stay in intensive care, etc.),
- Cannot be reached within the first 5 days after birth,
- Mothers who changed their residence to live in another city/district other than Manisa Central districts (Yunusemre and Şehzadeler) were excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: control
Pregnant women in the control group were given a booklet containing information about breastfeeding.
In the postpartum period, the breastfeeding process was observed with home visits and telephone for the first 6 months.
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Pregnant women in the control group were given only a breastfeeding booklet, breastfeeding status, breast problems and breastfeeding self-efficacy were evaluated during postnatal home visits and telephone interviews, and risky situations were referred to health professionals.
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Experimental: intervention
Pregnant women in the intervention group were given a booklet containing information about breastfeeding.
At the same time, individual breastfeeding support was provided with a wearable breastfeeding model.
In the postpartum period, the breastfeeding process was observed with home visits and telephone for the first 6 months.
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Pregnant women in the intervention group were given individual counseling with a wearable breastfeeding model.
During postnatal home visits, mothers were given support on breastfeeding, breast problems were addressed, and information was given to support the mother's self-efficacy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Situation of mothers feeding their babies exclusively with breast milk
Time Frame: 6 months
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Determination of mothers' status of exclusively breastfeeding their babies for the first 6 months using a survey form created by researchers.
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6 months
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Mothers experiencing breast problems
Time Frame: 6 months
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Determination of breast problems that occur during the breastfeeding process with a survey created by researchers.
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6 months
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Determination of mothers' breastfeeding self-efficacy
Time Frame: 6 months
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Breastfeeding competencies were assessed with the LATCH breastfeeding diagnostic tool and the breastfeeding self-efficacy scale.
Mothers' breastfeeding success was examined with the LATCH breastfeeding diagnostic tool.
On this scale, they can get a minimum of 0 and a maximum of 10 points.
As the score increases, breastfeeding success increases.
The breastfeeding self-efficacy scale determines the self-efficacy of mothers and can get a minimum of 33 and a maximum of 165 points.
As the average score increases, breastfeeding self-efficacy is expressed as high.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Seval Cambaz Ulaş, Manisa Celal Bayar University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2021
Primary Completion (Actual)
November 30, 2022
Study Completion (Actual)
February 6, 2023
Study Registration Dates
First Submitted
February 29, 2024
First Submitted That Met QC Criteria
March 25, 2024
First Posted (Actual)
April 2, 2024
Study Record Updates
Last Update Posted (Actual)
April 2, 2024
Last Update Submitted That Met QC Criteria
March 25, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- secil koken
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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