NCT06643546

Brief Summary

Objective: This study evaluated the effectiveness of breastfeeding education using different simulation techniques on nursing students' breastfeeding knowledge, counseling skills, and clinical self-efficacy. Method: The study sample consisted of 157 nursing students. Data were collected using a sociodemographic questionnaire, the Breastfeeding Assistance Clinical Preparedness Scale, the Breastfeeding Knowledge Form, the Clinical Self-Efficacy in Performance Scale, and the Breastfeeding Counseling Skills Checklist. Conclusion: We expect that simulation and standardized patient-based breastfeeding education will effectively improve nursing students' readiness for breastfeeding assistance, breastfeeding knowledge, breastfeeding counseling skills, and clinical self-efficacy in breastfeeding performance.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 10, 2024

Last Update Submit

October 13, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Breastfeeding Assistance Clinical Readiness Scale

    In the scale developed by the researchers, students evaluate themselves from 0 (not sure) to 10 (absolutely sure) based on the statement "I am ready to provide breastfeeding counseling and breastfeeding care to a mother who has given birth in the clinic.

    before training, 1 hour after training, 4 weeks after

  • Breastfeeding Information Form

    The Breastfeeding Information Form was prepared by researchers using the breastfeeding information inventory developed by Marzalik in 2004 and the competency verification toolkit guide published by the World Health Organization to ensure the competency of direct care providers in the implementation of the baby-friendly hospital initiative. The form consists of 25 statements. Participants are asked to answer each statement as true, false, and I don't know. A correct answer in the form is worth 1 point, and the highest score on the form is 25 and the lowest is 0. As the score received from the form increases, it is interpreted as the level of breastfeeding knowledge increases. In order to evaluate the appropriateness of the scope and content of the form, expert opinions will be obtained from at least 9 faculty members.

    before training, 1 hour after training, 4 weeks after

  • Self-efficacy scale in clinical performance

    In order to determine the self-efficacy perceptions of nursing students about their clinical performance, the Clinical Performance Self-Efficacy Scale (CPSES) was developed by Cheraghi et al. (2009) in 2009. The Turkish validity and reliability studies of the scale were conducted by Zaybak (2016). The scale, which consists of a total of 37 items, consists of 4 factors (sub-dimensions) as "Data collection", "Diagnosis and planning", "Application" and "Evaluation". The scale's total and sub-dimension score averages are evaluated by taking the item score average. A high score average obtained from the scale indicates that self-efficacy in clinical performance is high. The total Cronbach alpha coefficient of the scale was found to be 0.98.

    before training, 1 hour after training, 4 weeks after

  • Breastfeeding Counseling Skills List

    Created by researchers using professional practice guides. This skill list is used by the student during breastfeeding counseling. Scoring is done based on whether the breastfeeding counseling student demonstrates the skill. There are 25 steps in the skill list. Correct application is evaluated as 2 points, incomplete application as 1 point, and failure to apply as 0 points. The maximum score received from the list is 50 and the minimum score is 0. Expert opinions will be obtained from at least 9 faculty members in order to evaluate the appropriateness of the scope and content of the form

    4 week after training

Study Arms (3)

control

EXPERIMENTAL

received only theoretical breastfeeding training

Other: theoretical training

1st intervention group

EXPERIMENTAL

theoretical breastfeeding training and model simulation training accompanied by scenarios

Other: model simulation training

2nd intervention group

EXPERIMENTAL

theoretical breastfeeding training and live simulation training with scenarios

Other: live-simulation

Interventions

received only theoretical breastfeeding training

control

theoretical breastfeeding training and model simulation training accompanied by scenarios

1st intervention group

theoretical breastfeeding training and live simulation training with scenarios

2nd intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • having taken a gynecology and obstetrics nursing course, volunteering to participate in the research, and not having received formal training on breastfeeding.

You may not qualify if:

  • voluntarily withdrawing from the research and not participating in any stages of the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Nursing Faculty

Ankara, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PhD, Assistant Prof.

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 16, 2024

Study Start

July 1, 2024

Primary Completion

October 30, 2024

Study Completion

November 30, 2024

Last Updated

October 16, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations