The Effect of Breastfeeding Support on Exclusive Breastfeeding, Occurrence of Breast Problems and Breastfeeding Self-Efficacy

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06341140
• Other study ID #: secil koken
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: February 6, 2023

Study information

• Verified date: March 2024
• Source: Celal Bayar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 6, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion 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 Sehzadeler),
• 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 Sehzadeler),
• 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 Sehzadeler) were excluded from the study.

Related Conditions & MeSH terms

• Breastfeeding
• Breastfeeding, Exclusive

Intervention

Other:
• Breastfeeding support and Booklet containing information about breastfeeding
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.
• Booklet containing information about breastfeeding
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.

Locations

Country	Name	City	State
Turkey	Manisa Celal Bayar University	Manisa

Sponsors (2)

Lead Sponsor	Collaborator
Celal Bayar University	Manisa Celal Bayar University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mothers experiencing breast problems	Determination of breast problems that occur during the breastfeeding process with a survey created by researchers.	6 months
Primary	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