The Effect of Breastfeeding Support on Exclusive Breastfeeding, Occurrence of Breast Problems and Breastfeeding Self-Efficacy
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
1 other identifier
interventional
102
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2023
CompletedFirst Submitted
Initial submission to the registry
February 29, 2024
CompletedFirst Posted
Study publicly available on registry
April 2, 2024
CompletedApril 2, 2024
March 1, 2024
1.3 years
February 29, 2024
March 25, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Situation of mothers feeding their babies exclusively with breast milk
Determination of mothers' status of exclusively breastfeeding their babies for the first 6 months using a survey form created by researchers.
6 months
Mothers experiencing breast problems
Determination of breast problems that occur during the breastfeeding process with a survey created by researchers.
6 months
Determination of mothers' breastfeeding self-efficacy
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.
6 months
Study Arms (2)
control
EXPERIMENTALPregnant 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.
intervention
EXPERIMENTALPregnant 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.
Interventions
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.
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.
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celal Bayar Universitylead
- Manisa Celal Bayar Universitycollaborator
Study Sites (1)
Manisa Celal Bayar University
Manisa, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seval Cambaz Ulaş
Manisa Celal Bayar University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 29, 2024
First Posted
April 2, 2024
Study Start
August 1, 2021
Primary Completion
November 30, 2022
Study Completion
February 6, 2023
Last Updated
April 2, 2024
Record last verified: 2024-03