NCT05624047

Brief Summary

This study aimed to determine the effect of breastfeeding education given to pregnant women by a hybrid simulation method in the antenatal period on postpartum breastfeeding. This study will be carried out in a family health center in Turkey. Breastfeeding education will be given to pregnant women using a hybrid simulation method consisting of a wearable breast model and the standard patient in the intervention group. Women in the control group will receive only routine breastfeeding education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

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

First Submitted

Initial submission to the registry

November 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

November 13, 2022

Last Update Submit

August 12, 2023

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (5)

  • The Breastfeeding Self-Efficacy Scale-Short Form (Antenatal)

    The scale consists of 14 questions and is a five-point Likert type. The lowest score of 14 points and the highest of 70 points are obtained from the scale. The higher the score indicates a higher self-efficacy perception.

    Baseline: Between 32 and 36 weeks of pregnancy

  • The Breastfeeding Self-Efficacy Scale-Short Form (Postnatal)

    The scale consists of 14 questions and is a five-point Likert type. The lowest score of 14 points and the highest of 70 points are obtained from the scale. The higher the score indicates a higher self-efficacy perception.

    Postpartum on the fifth day

  • The Breastfeeding Self-Efficacy Scale-Short Form (Postnatal)

    The scale consists of 14 questions and is a five-point Likert type. The lowest score of 14 points and the highest of 70 points are obtained from the scale. The higher the score indicates a higher self-efficacy perception.

    Postpartum 6th week

  • LATCH Breastfeeding Assesment Tool

    The LATCH Breastfeeding Assesment Tool was developed to objectively evaluate breastfeeding success. LATCH consists of five evaluation criteria. Each criterion 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 higher score indicates a higher breastfeeding. success.

    Postpartum on the fifth day

  • LATCH Breastfeeding Assesment Tool

    The LATCH Breastfeeding Assesment Tool was developed to objectively evaluate breastfeeding success. LATCH consists of five evaluation criteria. Each criterion 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 higher score indicates a higher breastfeeding. success.

    Postpartum 6th week

Study Arms (2)

Experimental Group

EXPERIMENTAL

Breastfeeding education using the hybrid simulation method

Behavioral: Breastfeeding education using hybrid simulation methodBehavioral: Routine verbal breastfeeding education

Control Group

OTHER

Routine verbal breastfeeding education

Behavioral: Routine verbal breastfeeding education

Interventions

Breastfeeding education using hybrid simulation methodBEHAVIORAL

In addition to the verbal breastfeeding training given to the pregnant women assigned to the experimental group, breastfeeding training will be given using the hybrid simulation method consisting of a wearable breast model and standard patient practice.

Experimental Group
Routine verbal breastfeeding educationBEHAVIORAL

Women in this group will receive oral breastfeeding training, which is routinely given in the pregnant education class and consists of one session.

Control GroupExperimental Group

Eligibility Criteria

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

You may qualify if:

  • being between 32-36 weeks of pregnancy
  • being primipara or multipara
  • being at least literate
  • being planning to breastfeed
  • agreeing to participate in the study

You may not qualify if:

  • having a physical or mental health problem that would prevent breastfeeding
  • preterm labor (before 37 weeks)
  • either mother or baby having a health problem after birth
  • being with multiple pregnancy
  • being with high-risk pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bitlis Hüsrevpaşa Family Center

Bitlis, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Sultan Özkan Şat, Dr

    Bitlis Eren University

    PRINCIPAL INVESTIGATOR

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
Assistant Professor

Study Record Dates

First Submitted

November 13, 2022

First Posted

November 21, 2022

Study Start

December 1, 2022

Primary Completion

August 12, 2023

Study Completion

August 12, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations

TU(1)