NCT06458283

Brief Summary

It was planned to determine the effect of hybrid simulation-based breastfeeding training on the practical skills, satisfaction, self-confidence and self-efficacy of the students of the Department of Midwifery, Hamidiye Faculty of Health Sciences, University of Health Sciences

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

June 9, 2024

Last Update Submit

September 18, 2024

Conditions

Keywords

simulation based breastfeeding trainingbreast feedingmidwiferyeducationSimulationStandardized PatientHigh Fidelity Simulation Training

Outcome Measures

Primary Outcomes (6)

  • Self-EffectivenessEfficacy Scale

    TThe Self-Efficacy Scale is structured as a 5-point Likert scale consisting of 23 items, with a possible score range of 23 to 115. For each item in the scale, respondents are asked to mark one of the following options: 1) Does not describe me at all, 2) Describes me a little, 3) Neutral, 4) Describes me well, and 5) Describes me very well. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 are scored in reverse. A higher score indicates a higher perception of overall self-efficacy.

    immediately before simulation

  • Self-EffectivenessEfficacy Scale

    The Self-Efficacy Scale is structured as a 5-point Likert scale consisting of 23 items, with a possible score range of 23 to 115. For each item in the scale, respondents are asked to mark one of the following options: 1) Does not describe me at all, 2) Describes me a little, 3) Neutral, 4) Describes me well, and 5) Describes me very well. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 are scored in reverse. A higher score indicates a higher perception of overall self-efficacy.

    immediately after the simulation application

  • Self-EffectivenessEfficacy Scale

    The Self-Efficacy Scale is structured as a 5-point Likert scale consisting of 23 items, with a possible score range of 23 to 115. For each item in the scale, respondents are asked to mark one of the following options: 1) Does not describe me at all, 2) Describes me a little, 3) Neutral, 4) Describes me well, and 5) Describes me very well. Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, 17, 18, 20, and 22 are scored in reverse. A higher score indicates a higher perception of overall self-efficacy.

    4 weeks after the first simulation application

  • Introductory Information Form

    In this form, which was created by the researchers based on the literature, the participants' age, the high school they graduated from, the education level of their parents, their willingness to choose the profession, their feeling of belonging to the profession, etc. questions are included. The Introductory Information Form is in a multiple-choice format consisting of 25 questions by scanning the literature by the researchers.

    immediately before simulation

  • Student Satisfaction and Self-Confidence Scale in Learning

    The scale is a 13-item measurement tool designed to measure student satisfaction with simulation and self-confidence during practices. It is a 5-point Likert type and is scored as strongly disagree 1, disagree 2, undecided 3, agree 4, strongly agree 5.According to the Turkish adaptation of the scale, the total number of items is 12. This scale measures student satisfaction and self-confidence regarding learning in a simulation environment. The scale consists of two subheadings: "Satisfaction with Current Learning" and "Self-Confidence in Learning." The subheading "Satisfaction with Current Learning" includes 5 items, and the subheading "Self-Confidence in Learning" includes 7 items, with no negatively coded items.

    immediately after the simulation application

  • Simulation-Based Learning Assessment Scale

    The scale has 5 sub-dimensions (nursing process, patient safety, professional information, communication and reflected behavior) and consists of 37 items.All statements on the scale are positive, and there are no negatively coded items. The scale evaluates the essential competencies that a nurse should possess, including the nursing process, patient safety, professional knowledge, communication, and reflective behavior concepts. An increase in the score obtained from the sub-dimensions of the scale indica

    immediately after the simulation application

Secondary Outcomes (2)

  • BREASTFEEDING MANAGEMENT INFORMATION ATTITUDES AND SKILLS EVALUATION FORM

    immediately before simulation

  • BREASTFEEDING MANAGEMENT INFORMATION ATTITUDES AND SKILLS EVALUATION FORM

    4 weeks after the first simulation application

Study Arms (2)

Experimental Group

EXPERIMENTAL

Investigation of the effectiveness of scenario-based standardized patient simulation training and breastfeeding management of midwifery students

Other: hiybrid simulation

Control Group

EXPERIMENTAL

Standard training of midwifery students with low fidelty breast model

Other: control grup

Interventions

The intervention group students were given practical training on breast milk and breastfeeding management in the professional skills laboratory, accompanied by a high-reality simulator accompanied by a scenario, and the control group students were given practical training on breast milk and breastfeeding management in the professional skills laboratory, accompanied by an adult standard patient care model.

Experimental Group

low fidelity simulator

Control Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having a statement of consent Being a second year midwifery student

You may not qualify if:

  • Wishing to withdraw from the research at any time. Not participating in all simulation applications Incompletely filling out data collection forms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri Üniversitesi Hamidiye

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast FeedingHypersensitivity

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorImmune System Diseases

Study Officials

  • yasemin aydın kartal, Assoc. Prof

    SAĞLIK BİLİMLERİ ÜNİVERSİTESİ

    STUDY DIRECTOR
  • Ebru ÇALIŞKAN, PhD.Stu.

    SAĞLIK BİLİMLERİ ÜNİVERSİTESİ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Midwifery

Study Record Dates

First Submitted

June 9, 2024

First Posted

June 13, 2024

Study Start

May 10, 2023

Primary Completion

May 10, 2024

Study Completion

November 10, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations