- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07240727
The Effect of Role Differences on Learning and Self-Assessment in Simulation-Based Life Support Training Among Dental Students
An Investigation of the Effects of Different Practical Roles in Simulation-Based Intermediate Life Support Training on Theoretical Knowledge, Practical Skill Acquisition, and Self-Assessment Among Undergraduate Dental Students
Study Overview
Status
Conditions
Detailed Description
This study aims to investigate the development of theoretical knowledge and practical skills of fifth-year dental students through pre- and post-training assessments, and to compare outcomes between study groups. Prior to receiving theoretical instruction, students will complete a baseline knowledge questionnaire to assess their initial theoretical understanding. Similarly, an initial practical assessment using an Objective Structured Clinical Examination (OSCE) will be conducted to determine baseline practical competence.
Following detailed theoretical training and practical exercises, students will be divided into two groups for simulation-based practical sessions:
Group 1 (Practitioners): Students in this group will participate as practitioners in additional practical sessions following joint theoretical and practical training.
Group 2 (Evaluators): Students in this group will serve as evaluators during the additional practical sessions, using structured checklists developed with the instructor.
During the ILS simulation exercises, practitioner students are expected to detect cardiac and respiratory arrest in adult and pediatric scenarios and implement acute management steps, including activating emergency services (calling 112), requesting an automated external defibrillator, and utilizing emergency intervention equipment. Practitioners will perform chest compressions and positive pressure ventilation with 100% oxygen using appropriate devices. To simulate single- or multi-rescuer interventions, practitioner students will perform in groups of one or two, while evaluators observe and provide immediate feedback. Each student will assume a leadership role at least once, with assisting students following the leader's instructions.
Evaluator students will assess practitioner performance using checklists aligned with the latest American Heart Association (AHA) and European Resuscitation Council (ERC) Basic and Advanced Life Support guidelines. Evaluators will provide immediate feedback on any deficiencies or errors. After simulation sessions, students will undergo OSCE assessments encompassing both adult and pediatric scenarios to evaluate practical skills and theoretical knowledge acquisition. Assessments will be conducted by instructors using rubrics and checklists based on current AHA and ERC recommendations. In addition, students will perform self-assessments using the same rubrics to evaluate their own perception of competence. A minimum of 20 teams will be evaluated three times throughout the study: by the instructor, by their peers, and through self-assessment, enabling the monitoring of skill development and self-evaluation accuracy over time.
Inclusion Criteria:
Fifth-year students enrolled in the Faculty of Dentistry.
Exclusion Criteria:
Students unwilling to participate.
Students with more than 10% absenteeism in training sessions where missed content cannot be made up.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kırıkkale, Turkey (Türkiye)
- Kırıkkale University, Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Fifth-year students currently enrolled in the Faculty of Dentistry.
Exclusion Criteria:
- Students who declined to participate in the study were excluded.
- Students who demonstrated more than 10% absenteeism from the training sessions, where the missed sessions could not be made up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1
Practitioner
|
Students assigned to the practitioner arm participate in simulation-based practical sessions, taking the active role in managing adult, pediatric, and infant cardiac and respiratory arrest scenarios.
They perform all steps of intermediate life support (ILS), including detection of arrest, chest compressions, positive-pressure ventilation with 100% oxygen, calling emergency services (112), and requesting emergency equipment.
Practitioner students may act as single or multiple rescuers during simulations, and each student assumes a leadership role at least once.
|
|
Active Comparator: Group 2
Evaluator
|
Students assigned to the evaluator arm observe practitioner students during simulation-based practical sessions.
They use checklists based on current AHA and ERC guidelines to assess the practitioners' performance and provide immediate feedback.
Evaluators also complete self-assessment to measure their own perception of knowledge and practical skills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in theoretical knowledge and practical skill scores across two time points during Intermediate Life Support (ILS) training
Time Frame: Baseline (pre-training) and Post-training (within 20 minutes during pre and post training OSCE sessions)
|
Theoretical knowledge and practical skill levels of fifth-year dental students will be evaluated using written tests and Objective Structured Clinical Examinations (OSCEs) administered at two time points: before the training (baseline) and after the completion of the training (post-training).
Changes in scores across these time points will be analyzed to assess learning and clinical skill competence progression.
|
Baseline (pre-training) and Post-training (within 20 minutes during pre and post training OSCE sessions)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change and accuracy of self-assessment scores compared with peer and instructor evaluations during Intermediate Life Support (ILS) training
Time Frame: After each of the three simulation sessions (Session 1, Session 2, Session 3) (within 10 minutes during each sessions)
|
Evaluator and practitioner students will complete self-assessment rubrics after each of three simulation-based practical sessions.
These self-assessments will be conducted for a minimum of 20 student teams.
Scores will be compared with corresponding peer and instructor evaluations to assess the development and accuracy of students' self-assessment abilities over time.
The analysis will evaluate both intra-individual improvement and agreement with external assessments across the three evaluation rounds.
|
After each of the three simulation sessions (Session 1, Session 2, Session 3) (within 10 minutes during each sessions)
|
|
Quality of written documentation and feedback provided by students during the final OSCE
Time Frame: At the final OSCE (post-training assessment), (within 15 minutes during third OSCE station)
|
During the final OSCE (Objective Structured Clinical Examination), students will complete a written documentation task describing their approach to the simulated case and provide open-ended as well as rubric-based feedback regarding the training process.
|
At the final OSCE (post-training assessment), (within 15 minutes during third OSCE station)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KU-ERKAN-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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