Education, Nursing, BaccalaureateNCT07698327
Effects of Team-Based Simulation on Nursing Students' Soft Skills
A study testing Team-Based Simulation and Individual-Based Simulation in people with Education, Nursing, Baccalaureate and Team Patient Care, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Education, Nursing, Baccalaureate, Team Patient Care, Professional Competence
- What is being tested?
- Team-Based Simulation and Individual-Based Simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Dec 2025to 20 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Team-Based Sımulatıon On Developıng Communıcatıon, Self-Awareness, And Teamwork Skılls Of Nursıng Students: A Randomızed Controlled Study
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.
Read more
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.
Read the detailed description
This study utilizes a randomized, cross-over experimental design to evaluate the efficacy of team-based simulation versus individual-based simulation in nursing education. By employing a cross-over methodology, each participant serves as their own control, which minimizes inter-individual variability and enhances the statistical power of the analysis despite the sample size of 112 students.
The protocol involves a systematic delivery of clinical scenarios focused on fundamental nursing skills. In the team-based arm, participants are organized into groups of four, with designated roles such as team leader, medication administrator, primary caregiver, and documenter, which rotate to ensure comprehensive experience. The individual-based arm requires students to navigate the same clinical scenarios independently, focusing on autonomous decision-making and task prioritization without peer interaction.
The intervention is structured in three distinct phases:
Pre-intervention baseline assessment: Standardized measurement of participants' baseline self-awareness, communication traits, and existing teamwork perceptions.
Active simulation phase: Implementation of high-fidelity clinical simulations followed by immediate structured debriefing sessions. The debriefing component is grounded in reflective practice models to facilitate the transition of experiential learning into clinical competence.
Washout and cross-over period: A predetermined temporal interval to mitigate potential carry-over effects before participants switch experimental arms.
Data collection utilizes multi-dimensional psychometric instruments administered at four specific intervals: baseline, immediately post-first simulation, post-second simulation (crossover point), and a one-month follow-up. This longitudinal approach is specifically designed to evaluate the retention of skill acquisition and the durability of changes in self-awareness and team-based attitudes over time. The analysis will compare mean scores across these time points using repeated-measures ANOVA to determine the interaction effect between the teaching method and time, providing insight into the sustained impact of team-based learning environments.
- Conditions
- Education, Nursing, Baccalaureate, Team Patient Care, Professional Competence, Self-Awareness, Interprofessional Relations, Clinical Competence
- Being tested
- Team-Based Simulation, Individual-Based Simulation
- Keywords
- nursing education, communication, self-awareness, simulation based learning, teamwork
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team-Based SimulationBehavioural
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.
Individual-Based SimulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Team-Based Simulation; Behavioral: 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. Receives: Behavioral: Team-Based Simulation; Behavioral: Individual-Based Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start22 Dec 2025
- Primary completion11 Apr 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Education, Nursing, BaccalaureateStudies of the same condition, open and under way.
- More trials run by Istanbul Medipol University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pınar dogan, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698327
- Sponsor's protocol ID
- 2468024
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Team-Based Sımulatıon On Developıng Communıcatıon, Self-Awareness, And Teamwork Skılls Of Nursıng Students: A Randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT07698327
- Acronym / sponsor ID
- 2468024
- Conditions
- Education, Nursing, Baccalaureate, Team Patient Care, Professional Competence, Self-Awareness, Interprofessional Relations, Clinical Competence
- Keywords
- nursing education, communication, self-awareness, simulation based learning, teamwork
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 11 Apr 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study utilizes a randomized, cross-over experimental design to evaluate the efficacy of team-based simulation versus individual-based simulation in nursing education. By employing a cross-over methodology, each participant serves as their own control, which minimizes inter-individual variability and enhances the statistical power of the analysis despite the sample size of 112 students.
The protocol involves a systematic delivery of clinical scenarios focused on fundamental nursing skills. In the team-based arm, participants are organized into groups of four, with designated roles such as team leader, medication administrator, primary caregiver, and documenter, which rotate to ensure comprehensive experience. The individual-based arm requires students to navigate the same clinical scenarios independently, focusing on autonomous decision-making and task prioritization without peer interaction.
The intervention is structured in three distinct phases:
Pre-intervention baseline assessment: Standardized measurement of participants' baseline self-awareness, communication traits, and existing teamwork perceptions.
Active simulation phase: Implementation of high-fidelity clinical simulations followed by immediate structured debriefing sessions. The debriefing component is grounded in reflective practice models to facilitate the transition of experiential learning into clinical competence.
Washout and cross-over period: A predetermined temporal interval to mitigate potential carry-over effects before participants switch experimental arms.
Data collection utilizes multi-dimensional psychometric instruments administered at four specific intervals: baseline, immediately post-first simulation, post-second simulation (crossover point), and a one-month follow-up. This longitudinal approach is specifically designed to evaluate the retention of skill acquisition and the durability of changes in self-awareness and team-based attitudes over time. The analysis will compare mean scores across these time points using repeated-measures ANOVA to determine the interaction effect between the teaching method and time, providing insight into the sustained impact of team-based learning environments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Team-Based Simulation Followed by Individual-Based Simulation | Experimental | Behavioral: Team-Based Simulation, Behavioral: Individual-Based SimulationInitial 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. |
| Group B: Individual-Based Simulation Followed by Team-Based Simulation | Active comparator | Behavioral: Team-Based Simulation, Behavioral: Individual-Based SimulationInitial 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team-Based SimulationThe 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. | Behavioural | Group A: Team-Based Simulation Followed by Individual-Based Simulation, Group B: Individual-Based Simulation Followed by Team-Based Simulation |
| Individual-Based SimulationThe 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. | Behavioural | Group A: Team-Based Simulation Followed by Individual-Based Simulation, Group B: Individual-Based Simulation Followed by Team-Based Simulation |
Primary outcome
Change in nursing students' teamwork attitudes.
Time frame: 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
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)
Change in nursing students' self-awareness levels.
Time frame: 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
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)
Change in nursing students' communication skills.
Time frame: 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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team-Based Simulation and Individual-Based Simulation in people with Education, Nursing, Baccalaureate and Team Patient Care, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nursing students' teamwork attitudes. (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.