NCT06116448

Brief Summary

The study aimed to determine the effect of different simulation methods on nursing students' self-confidence, satisfaction, and clinical breastfeeding management knowledge and skills in managing and supporting breastfeeding in the early postpartum period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

24 days

First QC Date

October 23, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

breastfeedingnursing studentsNursing Research, Educational

Outcome Measures

Primary Outcomes (3)

  • breastfeeding management knowledge

    The researchers developed a measurement tool to assess information. The tool uses a scoring system where correct statements receive one point and incorrect statements receive zero points. The total score ranges from 0 to 47 points.

    change from before implemention and 5th week of after practice

  • breastfeeding management skills

    The researchers developed a checklist to assess skills. The tool uses a scoring system where correct practice receives one point and incorrect statements receive zero points. The checklist consists of seven sections. The number of items in each section ranges from 4 to 14.

    through simulation practices completion, an average of 5 weeks and through clinical practices completion, an average of 5 weeks

  • Evaluation of Breastfeeding Education

    The researchers developed a measurement tool to assess breastfeeding education. The form items are evaluated as feeling adequate or inadequate (1 or 0 points). The total score ranges from 0 to 27 points.

    change from before implemention and 5th week of after practice

Secondary Outcomes (3)

  • students' self-confidence and satisfaction

    through simulation practices completion, an average of 5 weeks

  • self-evaluation

    through simulation practices completion, an average of 5 weeks

  • education methods satisfaction

    through simulation practices completion, an average of 5 weeks and through clinical practices completion, an average of 5 weeks

Study Arms (4)

high-fidelity simulation

EXPERIMENTAL

These students participated in a breastfeeding management scenario with a high-fidelity simulation mannikin named Noella S554.100 (n=11).

Other: high-fidelity simulation

hybrid simulation

EXPERIMENTAL

These students participated in the same breastfeeding management scenario with a standardized patient (n=11).

Other: hybrid simulation

telesimulation

EXPERIMENTAL

These students participated in the same breastfeeding management scenario with a standardized patient via Microsoft Teams video conferencing. (n=11)

Other: telesimulation

control

NO INTERVENTION

The students in this group were the control group, and no intervention was made.

Interventions

The high-fidelity simulation involved a student and a computer-based mannikin. Prior to the start of the scenario, a pre-briefing session was provided. The scenario was executed with the help of the researcher from the control room. The student's performance during the simulation was recorded with video. Each simulation lasted around 30 minutes. Following the simulation, a debriefing session was held with the student, and feedback was provided. Scales were used to assess the implementation of the practices.

high-fidelity simulation

The hybrid simulation involved a student and a standardized patient. The patient wore a wearable breast model and held a model baby. Prior to the start of the scenario, a pre-briefing session was provided. The student's performance during the simulation was recorded with video. Each simulation lasted around 30 minutes. Following the simulation, a debriefing session was held with the student, and feedback was provided. Scales were used to assess the implementation of the practices.

hybrid simulation

The telesimulation involved a student and a standardized patient. The patient wore a wearable breast model and held a model baby. Students and patients communicated via video conferencing. Prior to the start of the scenario, a pre-briefing session was provided. The student's performance during the simulation was recorded with video. Each simulation lasted around 30 minutes. Following the simulation, a debriefing session was held with the student, and feedback was provided. Scales were used to assess the implementation of the practices.

telesimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The voluntarily agree to participate in the study Not having experience with simulation Being a 3rd year nursing undergraduate student not working as a nurse

You may not qualify if:

  • During the study, participants must complete all forms, attend all theoretical training, and remain in the study until completion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sümeyye Bakır

Izmir, 35040, Turkey (Türkiye)

Location

Related Publications (3)

  • Sittner BJ, Aebersold ML, Paige JB, Graham LL, Schram AP, Decker SI, Lioce L. INACSL Standards of Best Practice for Simulation: Past, Present, and Future. Nurs Educ Perspect. 2015 Sep-Oct;36(5):294-8. doi: 10.5480/15-1670.

    PMID: 26521497BACKGROUND
  • Toruner EK, Altay N, Arpaci T, Sari Ozturk C, Ceylan C, Yildiz S, Cakir G. The development of a self-evaluation scale for simulation laboratory practices. Nurse Educ Today. 2021 Sep;104:104990. doi: 10.1016/j.nedt.2021.104990. Epub 2021 Jun 2.

    PMID: 34146847BACKGROUND
  • Moloney M, Murphy L, Kingston L, Markey K, Hennessy T, Meskell P, Atkinson S, Doody O. Final year undergraduate nursing and midwifery students' perspectives on simulation-based education: a cross-sectional study. BMC Nurs. 2022 Nov 6;21(1):299. doi: 10.1186/s12912-022-01084-w.

    PMID: 36335322BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • sümeyye bakır, master

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The students who participated in the research were unaware of which group they were assigned to and attended the practices accordingly. During the clinical follow-up phase, a clinical breastfeeding nurse evaluated the practices using a checklist but did not know which group the students belonged to.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: prospective, parallel, randomized, controlled quasi-experiment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctoral student/research assistant

Study Record Dates

First Submitted

October 23, 2023

First Posted

November 3, 2023

Study Start

November 4, 2022

Primary Completion

November 28, 2022

Study Completion

January 11, 2023

Last Updated

November 3, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

The researchers intend to publish the study as an article

Shared Documents
STUDY PROTOCOL
Time Frame
from January 2025
Access Criteria
the article is planned to be published as open access

Locations