NCT06081374

Brief Summary

In the literature, there are studies conducted to determine the effect of simulation-based and different training techniques models given in the prenatal period on postpartum breastfeeding self-efficacy. However, no study was found that evaluated the effects of simulation-based and different training techniques given in the prenatal period on breastfeeding self-efficacy and breastfeeding problems. Therefore, this study was planned to determine the effect of simulation-based breastfeeding education on breastfeeding self-efficacy and breastfeeding problems in the prenatal period.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

July 10, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

July 10, 2023

Last Update Submit

October 11, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • simulation affect on breastfeeding self-efficacy

    It is planned to increase women's breastfeeding self-efficacy through training Breastfeeding Self-efficacy scale points are supposed to be between 14-70 points. Getting higher points shows better breastfeeding self-efficacy.

    postpartum 7th week

  • simulation affect on breastfeeding problems

    It is planned to prevent possible breast problems with the training given to women. It is supposed to get points from 18 to 90 related to Breastfeeding Experience Scale.Getting lower points is more preferable than higher points. Getting points near to 90 shows increased problems related to breastfeeding.

    postpartum 7th week

Study Arms (3)

simulation intervention

EXPERIMENTAL

simulation will be implemented.

Device: simulation implication

education implication

ACTIVE COMPARATOR

education will be implemented.

Device: simulation implication

control group

NO INTERVENTION

no intervention will be made.

Interventions

Breastfeeding education is planned by dressing pregnant women with simulation models.

Also known as: nursing education
education implicationsimulation intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women will be included
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnants between32nd-36th gestational weeks,
  • Primigravida,
  • Planning to breastfeed,
  • 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 risky pregnancy, Having received a planned breastfeeding training before,
  • Premature birth (before 37th weeks of gestation),
  • Having a systemic/chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seda Karaçay Yıkar

Adana, Sarıcam, 00130, Turkey (Türkiye)

Location

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

July 10, 2023

First Posted

October 13, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

October 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

data will be kept in confident

Locations