NCT05340842

Brief Summary

This study is a randomized controlled experimental study conducted to determine the effect of applied breastfeeding training given through Lactation Simulation Model (LSM) in antenatal period on the success of women in breastfeeding, their self-efficacy perception regarding breastfeeding and their attitude towards and knowledge of breastfeeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

April 4, 2022

Last Update Submit

December 4, 2024

Conditions

Keywords

antenatal periodsimulation based breastfeeding training

Outcome Measures

Primary Outcomes (1)

  • LATCH Breastfeeding Diagnostic and Assessment Scale

    LATCH consists of the combination of the first letters of the English equivalent of the five criteria defined above. Each item is evaluated between 0-2 points. The lowest score that can be obtained from the entire scale is 0 and the highest score is 10. The scale has no breakpoints. The low score on the scale indicates the need for active intervention, support and follow-up after discharge in breastfeeding. The higher the LATCH Breastfeeding Diagnosis and Evaluation Scale score, the higher the success of breastfeeding. Cronbach's alpha value was found to be 0.95 in the study in which the Turkish validity and reliability of the scale was carried out.

    The scale was filled twice, with an average of two hours, in the first 24 hours after delivery, when the mother was free of pain and felt well.

Secondary Outcomes (2)

  • Breastfeeding Attitude and Knowledge Questionnaire

    It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.

  • Breastfeeding Self-Efficacy Scale-Short Form

    It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.

Study Arms (2)

Simulation training experiment group

EXPERIMENTAL

In this training, the researcher firstly explained breastfeeding by wearing the Lactation Simulation Model on himself and showing it practically on himself. Afterwards, the model was dressed on the pregnant woman and the pregnant woman was given one-on-one breastfeeding practice. In this process, all questions of the pregnant woman were answered by the researcher.

Other: simulation training group

Control group

NO INTERVENTION

At this stage, the standard video screening prepared for breastfeeding education within the scope of the hospital protocol was shown to the pregnant woman by the researcher with a tablet.

Interventions

In this study, applied breastfeeding training with Lactation Simulation Model was given to pregnant women in the intervention group (simulation training group, n=64) during antenatal period

Simulation training experiment group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • between gestational weeks Primigravida No systemic/chronic disease Planning to breastfeed Who has not received a planned breastfeeding training before Can speak and understand Turkish Pregnant women who agreed to participate in the study were included.

You may not qualify if:

  • Breastfeeding contraindications Having a high-risk pregnancy Preterm delivery (before 37 weeks of gestation) Having a health condition that prevents breastfeeding in the newborn after birth Having mental disability and serious mental disorder Women with multiple pregnancies were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamide Arslan Tarus

Istanbul, Maltepe, 34844, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Hamide Arslan Tarus, Res. Asist.

    Marmara University

    PRINCIPAL INVESTIGATOR
  • Gonul Kurt, Assist. Prof

    Gulhane Faculty of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Principal Investigator

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 22, 2022

Study Start

June 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations