NCT07698327

Brief Summary

Objective: This study aims to investigate the effects of "team-based simulation" on the development of communication skills, self-awareness levels, and teamwork competencies among first-year nursing students. Hypotheses: H1: Team-based simulation training significantly increases the self-awareness levels of nursing students compared to individual-based training. H2: Team-based simulation practices lead to a statistically significant improvement in students' attitudes toward teamwork, specifically regarding mutual support and team structure. H3: Students who participate in team-based simulations demonstrate higher levels of satisfaction with learning and self-confidence compared to those in individual-based settings. Study Description: The research was conducted with 112 first-year nursing students using a randomized controlled and "cross-over" design. Participants were divided into two groups, experiencing both team-based and individual-based simulation applications in different sequences. Data were collected at four different time points-pre-test, intra-post-simulation, and one-month follow-up-using various scales. The study determined that team-based simulation lays the groundwork for the development of students' self-awareness, enhances teamwork skills, and increases satisfaction levels. To ensure the sustainability of these gains, it is recommended that such interactive and repetitive simulation methods be systematically integrated into nursing education curricula.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

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

December 22, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 1, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

nursing educationcommunicationself-awarenesssimulation based learningteamwork

Outcome Measures

Primary Outcomes (3)

  • Change in nursing students' teamwork attitudes.

    The metric is the mean change in scores on the Teamwork Attitudes Scale, which evaluates key domains including mutual support, team structure, and leadership dynamics within the clinical simulation environment. Total scores on this scale range from 28 to 140, where higher scores indicate a better outcome (higher teamwork attitudes)

    Measured at baseline (pre-intervention), within 24 hours post-first simulation, within 24 hours post-second simulation (cross-over point), and at 1-month follow-up post-second simulation

  • Change in nursing students' self-awareness levels.

    The metric is the change in mean scores on the validated Self-Awareness Scale. This scale assesses the students' ability to recognize their own clinical decision-making processes, emotional responses, and professional behaviors during simulation scenarios. Total scores on this scale range from 0 to 75, where higher scores indicate a better outcome (higher self-awareness)

    Measured at baseline (pre-intervention), within 24 hours post-first simulation, within 24 hours post-second simulation (cross-over point), and at 1-month follow-up post-second simulation

  • Change in nursing students' communication skills.

    The metric is the mean change in scores obtained from a standardized clinical communication assessment rubric. This tool evaluates the clarity, accuracy, and efficiency of information exchange between students and simulated patients or team members. Total scores on this scale range from 25 to 125, where higher scores indicate a better outcome (higher communication skills)

    Measured at baseline (pre-intervention), within 24 hours post-first simulation, within 24 hours post-second simulation (cross-over point), and at 1-month follow-up post-second simulation

Study Arms (2)

Group A: Team-Based Simulation Followed by Individual-Based Simulation

EXPERIMENTAL

Initial Phase: Participants are assigned to a team-based simulation module where groups of four students engage in structured clinical scenarios. Sequence: Following the initial intervention and a defined washout period, these participants transition to the individual-based simulation module to perform the same clinical tasks independently. Goal: To assess the impact of collaborative learning on clinical performance and team dynamics before evaluating the impact of independent practice.

Behavioral: Team-Based SimulationBehavioral: Individual-Based Simulation

Group B: Individual-Based Simulation Followed by Team-Based Simulation

ACTIVE COMPARATOR

Initial Phase: Participants begin with the individual-based simulation module, focusing on autonomous decision-making and task completion without peer assistance. Sequence: Following the initial intervention and a defined washout period, these participants transition to the team-based simulation module, where they participate in group-based clinical scenarios. Goal: To establish a baseline of individual clinical competency before introducing the collaborative elements of team-based learning.

Behavioral: Team-Based SimulationBehavioral: Individual-Based Simulation

Interventions

The team-based simulation intervention is designed to foster collaborative clinical reasoning and interprofessional communication. Students are organized into four-member teams, with specific roles-team leader, medication administrator, primary caregiver, and documentation assistant-assigned to ensure structured task delegation. The intervention emphasizes collective decision-making, mutual support, and the utilization of team structure to navigate high-fidelity clinical scenarios. Each simulation is immediately followed by a structured, video-assisted debriefing process conducted in a group format. This session focuses on the "team process" and communication dynamics, encouraging students to analyze their interaction patterns and the impact of collective effort on patient outcomes. The intervention is delivered in an accredited nursing skill laboratory, ensuring standardized conditions across all group sessions.

Group A: Team-Based Simulation Followed by Individual-Based SimulationGroup B: Individual-Based Simulation Followed by Team-Based Simulation

The individual-based simulation intervention focuses on the cultivation of autonomous clinical judgment and the mastery of independent psychomotor skills. Each student navigates the clinical scenarios independently, assuming full responsibility for the entire clinical process, including assessment, decision-making, and task implementation, without the benefit of peer collaboration. This arm requires students to independently manage time and prioritize nursing interventions within the simulation environment. The subsequent debriefing process is tailored to the individual, focusing on personalized reflection, clinical reasoning errors, and technical skill refinement. Like the team-based sessions, these activities are conducted in an accredited skill laboratory using the same clinical scenarios to ensure that the educational content remains equivalent, allowing for a precise evaluation of the teaching methodology's impact on individual performance.

Group A: Team-Based Simulation Followed by Individual-Based SimulationGroup B: Individual-Based Simulation Followed by Team-Based Simulation

Eligibility Criteria

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

You may qualify if:

  • Must be currently enrolled as a first-year student in the Faculty of Nursing
  • Must have voluntarily agreed to participate in the study and signed the informed consent form.
  • Must be physically and cognitively capable of participating in the simulation-based learning activities.
  • Must have completed the introductory nursing orientation program.

You may not qualify if:

  • Students who have previously received formal simulation-based training in a clinical environment.
  • Students who are unable to commit to the full duration of the crossover study protocol, including the one-month follow-up assessment.
  • Students who have an active participation in another concurrent educational research study that may influence self-awareness or teamwork scores.
  • Students who are unable to attend the scheduled simulation sessions due to pre-existing academic or personal obligations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merve Tarhan

Istanbul, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 13, 2026

Study Start

December 22, 2025

Primary Completion

April 11, 2026

Study Completion

May 20, 2026

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Data Availability: De-identified individual participant data (IPD) will be made available upon reasonable request to qualified researchers who provide a methodologically sound proposal for secondary analysis. Access Requirements: Researchers seeking access must sign a data use agreement to ensure the privacy and confidentiality of the participants. Timeline: Data will be available starting 6 months after the primary study results are published and will remain accessible for a period of 5 years. Request Process: Interested parties should submit their research proposals to the Principal Investigator via email (Pınar Doğan, pdogan@medipol.edu.tr). All requests will be evaluated based on scientific merit and ethical considerations.

Shared Documents
STUDY PROTOCOL
Time Frame
Start Date: 6 months after the publication of the primary study results. End Date: 5 years after the initial date of availability.

Locations