NCT04515862

Brief Summary

H1: "Breastfeeding Self-Efficacy Status" is higher in mothers who received postnatal hospital-based breastfeeding group training compared to the control group receiving routine care. H2: The level of knowledge obtained according to the "Pre-test Post-test Question Form" in mothers who received postnatal hospital-based breastfeeding group training is higher than before the education. H3: The status of starting and successfully continuing breastfeeding is higher in mothers who received postnatal hospital-based breastfeeding group training compared to the control group who received routine care.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Status
completed

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, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2016

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

August 13, 2020

Last Update Submit

August 15, 2020

Conditions

Keywords

Breastfeedinggroup trainingSelf-Effıcacy

Outcome Measures

Primary Outcomes (3)

  • Breastfeeding Self-Efficacy Scale

    This scale was developed by Cindy-Lee Dennis to measure breastfeeding competence and consists of 2 subscales and 33 items. The Turkish validity and reliability of the breastfeeding proficiency scale was made by Ekşioğlu and Çeber (2011). Breastfeeding self-efficacy increases as the total score increases in the 5-point Likert-type scale with a Cronbach Alpha coefficient of 0.91. The lowest score is 33, the highest score is 165.

    twelve weeks

  • Pre-Test Post-Test Information Form

    It is a question form consisting of 25 questions in order to evaluate the knowledge about breastfeeding and breast milk before and after the training. The first application was done before the training and the second application was carried out in the 12th week.

    twelve weeks

  • Breastfeeding levels of mothers

    The exclusive breastfeeding levels of their babies in the fourth and twelfth weeks of the mothers who received and did not receive education were evaluated.

    four weeks, twelve weeks

Study Arms (2)

intervention

EXPERIMENTAL

Intervention group: Mothers in the intervention group were included in the breastfeeding training program with the group training method. The training program was developed by the researchers, and the content of the program was evaluated with the expert opinion of academicians, obstetricians, nurses and breastfeeding counselor midwives working on breastfeeding.

Other: Breastfeeding education

control

NO INTERVENTION

Control Group:Routine obstetric care and treatment procedures were applied to the mothers in the control group. In the hospital where the study was conducted, all mothers are routinely evaluated for breastfeeding by an infant nurse.

Interventions

The importance of breastfeeding Benefits of breastfeeding for mother and baby Structure of the breast and milk production Breastfeeding techniques and positions Breastfeeding problems and breast care

intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbreastfeeding education was given to women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Can be contacted,
  • had a single birth,
  • Those who are 18 years old or older,
  • Residing in Izmir,
  • able to use phone
  • were determined to be mothers with no health problems in the mother and the baby

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.

    PMID: 14649593BACKGROUND
  • Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia Pac J Public Health. 2016 Jan;28(1):7-14. doi: 10.1177/1010539515624964.

    PMID: 26792873BACKGROUND
  • Yilmaz M, Aykut M. The effect of breastfeeding training on exclusive breastfeeding: a randomized controlled trial. J Matern Fetal Neonatal Med. 2021 Mar;34(6):925-932. doi: 10.1080/14767058.2019.1622672. Epub 2019 Jul 25.

    PMID: 31345049BACKGROUND
  • Eksioglu AB, Ceber E. Translation and validation of the Breast-feeding Self-efficacy Scale into Turkish. Midwifery. 2011 Dec;27(6):e246-53. doi: 10.1016/j.midw.2010.10.009. Epub 2010 Dec 8.

    PMID: 21145148BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The study was applied to mothers who gave birth at a time when they felt well after being taken to their postnatal room. First, the mothers who met the inclusion criteria were informed, after obtaining written consent, the mothers were randomized using a random number table and then assigned to the intervention and control groups. All mothers were asked to fill in the breastfeeding self-efficacy scale form together with the questionnaire before the intervention. Later, a training program was conducted in the hospital with the mothers in the intervention group. In the data collection phase of the study, 1180 women were evaluated in terms of sampling criteria. 1152 women (who did not meet the criteria or refused to participate) were excluded from the study. 90 randomized women were divided into two groups as intervention and control group. During the follow-up, 5 women in the intervention group and 5 women in the control group were excluded from the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 17, 2020

Study Start

August 1, 2015

Primary Completion

January 30, 2016

Study Completion

March 15, 2016

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share