NCT07250451

Brief Summary

The aim of this study is to determine the effect of integrated education, combining clinical practice and simulation laboratory training, on the competence of second-year undergraduate nursing students. This research is designed as a multi-crossover quasi-experimental randomized controlled study. In this model, all groups were exposed to simulation training sessions in specific stages. This design is currently used in the clinical practice component of the Surgical Nursing course. Additionally, the researchers aimed to answer the question: "What is the most appropriate timing for simulation training to enhance nursing students' competence?" During the clinical practice of the Surgical Diseases Nursing course, approximately 29-33 students participated in the simulation laboratory sessions, while about 61-65 students were involved in clinical field practice. For the simulation sessions, subgroups consisting of 4-5 students were formed. After each subgroup completed the simulation practice, a debriefing session was conducted. Each simulation scenario and related training lasted approximately half a day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 18, 2025

Last Update Submit

November 25, 2025

Conditions

Keywords

nursing educationSimulation practicenursing students

Outcome Measures

Primary Outcomes (2)

  • Nursing Competence

    The primary outcome is the level of nursing competence of second-year undergraduate nursing students, measured using a validated Nursing Competence Scale. Competence assessment includes clinical skills, decision-making, and ability to apply theoretical knowledge in simulation and clinical practice settings.

    up to 12 weeks

  • Simulation Learning

    Learning outcomes specific to simulation sessions were assessed using the Simulation Learning Evaluation Scale. This scale measures students' understanding, performance, and ability to apply skills in the simulated environment. Administered to each laboratory subgroup after simulation.

    up to 12 weeks

Secondary Outcomes (1)

  • Demographic Data

    Baseline (pre-intervention)

Study Arms (3)

Simulation-First Hybrid Training

EXPERIMENTAL

Students in Simulation-First Hybrid Training participated in four days of simulation-based training followed by eight days of clinical practice. Simulation sessions were conducted in subgroups of 4-5 students, followed by debriefing sessions. Clinical practice was conducted in hospital settings under faculty supervision.

Other: Educational/training

Clinical Practice-Simulation-Clinical Practice (Integrated Training)

EXPERIMENTAL

Students in Clinical Practice-Simulation-Clinical Practice (Integrated Training) first completed four days of clinical practice, then four days of simulation-based training, followed by an additional four days of clinical practice. Simulation and clinical practice sessions were conducted as described for Simulation-First Hybrid Training.

Other: Educational/training

Clinical Practice-First Training Followed by Simulation

EXPERIMENTAL

Students in Clinical Practice-First Training Followed by Simulation completed eight days of clinical practice, followed by four days of simulation-based training. Simulation and clinical practice sessions were conducted as described for Simulation-First Hybrid Training.

Other: Educational/training

Interventions

Simulation-First Hybrid Training - Simulation → Clinical Practice: Students first participated in four days of simulation in subgroups of 4-5, using low-fidelity mannequins for scenarios such as colorectal surgery care, subdural hematoma, BPH surgery, coronary bypass, femur fracture, and total laryngectomy. Prebriefing and debriefing (GAS method) were conducted. This was followed by eight days of clinical practice under faculty supervision. Clinical Practice-Simulation-Clinical Practice (Integrated Training) - Clinical Practice → Simulation → Clinical Practice: Students completed four days of clinical practice, four days of simulation as above, then four additional clinical practice days. Clinical Practice-First Training Followed by Simulation - Clinical Practice → Simulation: Students completed eight days of clinical practice followed by four days of simulation. Simulation sessions and clinical practice were conducted under faculty supervision.

Clinical Practice-First Training Followed by SimulationClinical Practice-Simulation-Clinical Practice (Integrated Training)Simulation-First Hybrid Training

Eligibility Criteria

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

You may qualify if:

  • Undergraduate nursing students enrolled in the second year of the program
  • Willing to participate in the study

You may not qualify if:

  • Students under 18 years of age
  • Students who do not provide voluntary consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duzce University

Düzce, 81000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behavior

Interventions

Training Support

Intervention Hierarchy (Ancestors)

Financial SupportEconomicsHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study was conducted as an open-label educational intervention. Neither participants nor researchers were blinded to group assignment due to the nature of the simulation and clinical training interventions. Data were entered into a statistical program and analyzed by an expert statistician who was blinded to group allocation.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: This study used a quasi-experimental, randomized, crossover design. All groups were exposed to both simulation-based training and clinical practice in different sequences. Each student participated in both intervention conditions at different time points, allowing within-subject comparison of competence outcomes. The study used a quasi-experimental, randomized, crossover design. After obtaining written consent, students who agreed to participate were stratified by gender and randomly assigned to one of three groups (A, B, or C) by a blinded faculty member to avoid allocation bias. Group A: Participated in four simulation days followed by eight clinical practice days. Group B: Completed four clinical practice days, then four simulation days, and finally four additional clinical practice days. Group C: Completed eight clinical practice days followed by four simulation days.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 26, 2025

Study Start

January 15, 2024

Primary Completion

June 15, 2024

Study Completion

August 15, 2024

Last Updated

November 26, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

ndividual participant data will not be shared due to privacy and ethical considerations of student participation.

Locations