NCT06454786

Brief Summary

The aim of this study was to determine the impact of training provided through simulation method on self-confidence and stress levels in nursing students during patient intervention.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

June 6, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

June 6, 2024

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

1 day

First QC Date

June 6, 2024

Last Update Submit

July 28, 2024

Conditions

Keywords

Simulation TrainingNursing StudentSelf ConfidenceStress

Outcome Measures

Primary Outcomes (1)

  • Self-Confidence/Efficacy Scale in Patient Intervention

    The scale developed for health professional students with scenario-based simulation-based teaching experience includes 18 items and is evaluated according to a 5-point Likert system (1 = Strongly Disagree, 2 = Disagree, 3 = Undecided, 4 = Agree, 5 = Strongly Agree). While a high score means confidence, a low score means lack of self-confidence in students. Therefore, in clinical practice, the highest possible score is 55 and the lowest score is 11.

    Pre-test, post-test (2nd weeks later)

Secondary Outcomes (1)

  • Perceived Stress Scale for Nursing

    Pre-test, post-test (2nd weeks later)

Study Arms (2)

simülation intervention group

EXPERIMENTAL

The Student Diagnosis Form, Self-Confidence/Efficacy Scale in Patient Intervention and Perceived Stress Scale will be applied first to this group. Then, face-to-face theoretical training will be given. Following the theoretical training, simulation training will be given in the Simulation Laboratory in line with the Nursing Care Scenario in Cardiogenic Shock. Simulation training will be conducted in 10 groups of 5 people and will be completed in 2 days. Each student in the group will actively participate in the simulation training within the scope of their role in the scenario. Posttests will be administered to both groups 2 weeks after the simulation training.

Other: Simulation Method

Control group

NO INTERVENTION

The Student Diagnosis Form, Self-Confidence/Efficacy Scale in Patient Intervention and Perceived Stress Scale will be applied first to this group. Then, face-to-face theoretical training will be given. Post-tests will be administered 2 weeks after the theoretical training.

Interventions

Management of cardiogenic shock scenario on an advanced simulation mannequin

simülation intervention group

Eligibility Criteria

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

You may qualify if:

  • Volunteering to participate in the research, being a senior nursing student

You may not qualify if:

  • Not participating in any simulation training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Kent University

Istanbul, Kağıthane, 34406, Turkey (Türkiye)

RECRUITING

Study Officials

  • SEHER YURT

    Istanbul Kent University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SEHER YURT, Ph.D

CONTACT

Zahide Aksoy, MSc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In order to prevent selection bias in the study, the assignment to the experimental and control groups will be made on a computer by a person who is unfamiliar with the research process. The analysis of the data will be done by a statistics expert who is outside the research process.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two groups with experimental and control groups
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 12, 2024

Study Start

June 6, 2024

Primary Completion

June 7, 2024

Study Completion

August 20, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations