- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07698327
Effects of Team-Based Simulation on Nursing Students' Soft Skills
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.
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Istanbul, Turecko (Türkiye), 34810
- Merve Tarhan
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Group A: Team-Based Simulation Followed by Individual-Based Simulation
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. |
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.
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.
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Aktivní komparátor: Group B: Individual-Based Simulation Followed by Team-Based Simulation
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. |
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.
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in nursing students' teamwork attitudes.
Časové okno: 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)
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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
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Change in nursing students' self-awareness levels.
Časové okno: 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)
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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
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Change in nursing students' communication skills.
Časové okno: 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)
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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
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 2468024
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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