- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07435233
Different Reality Simulation Education Methods on Nursing Students (Experimental)
Comparison of the Effects of Different Reality Simulation Education Methods on Nursing Students' Knowledge, Skills, Satisfaction and Self-Confidence Levels Related to Tracheal Aspiration: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Trabzon, Turkey (Türkiye)
- Karadeniz Technical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being a first-year nursing student and currently continuing education,
- Having attended the tracheal aspiration (TA) theoretical and laboratory training provided within the scope of this study,
- Agreeing to participate in the study.
Exclusion Criteria:
- Not having attended the TA theoretical and laboratory training provided within the scope of this study,
- Having prior educational experience related to basic nursing skills,
- Currently studying in or having graduated from a vocational health high school or any health-related high school, associate, or undergraduate program,
- Refusing to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Group 1: High-Fidelity Simulation Group
Experimental Group 1 (High-Fidelity Simulation Group): Nursing students in this group will receive training using a high-fidelity (high-reality) simulator. The simulation scenario will be conducted in a fully immersive environment designed to closely replicate clinical conditions. |
It is life-sized and allows for the application of different patient scenarios, simulating eye blinking, pupil reaction, speech sounds, normal and abnormal respiratory and heart sounds, enabling the measurement of normal and abnormal vital signs (oxygen saturation, respiration, pulse, blood pressure, body temperature), allowing for peripheral venous catheterization and bladder catheterization, featuring movable head and chin, a flexible mouth structure for insertion of the endotracheal tube, and facilitating aspiration procedures.
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Experimental: Experimental: Group 2: Hybrid Simulation Group
Experimental Group 2 (Hybrid Simulation Group): Nursing students in this group will be trained using a hybrid simulation model that combines simulation-based applications with additional instructional components. |
This technique is based on simulating the intermediate devices used in diagnosis and treatment, rather than simulating the human body itself.
In patient diagnosis and treatment, values are monitored on a patient monitor, sounds from various parts of the body are listened to with a stethoscope, and other procedures are performed using similar intermediate devices.
Therefore, simulating these intermediate devices provides a similar simulation experience.
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Other: Control Group: Routine Skills Training Group
Control Group (Routine Skills Training Group): Students in the control group will receive traditional skills training using a standard skills mannequin as part of routine laboratory practice. |
The skills mannequin is a life-size, training simulation dummy routinely used in laboratory classes.
It allows for the step-by-step performance of tracheal aspiration (TA), features a flexible mouth structure enabling insertion of an endotracheal tube, and can simulate normal/abnormal breathing and heart sounds.
It also has features supporting the measurement of vital signs such as oxygen saturation, respiration, pulse, blood pressure, and body temperature.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tracheal Aspiration Knowledge Test
Time Frame: before the intervention, immediately after the intervention, and at a two-week follow-up
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How do different simulation methods affect students' knowledge levels regarding tracheal aspiration procedure?
The Tracheal Aspiration Knowledge Test is a 20-item assessment tool developed by researchers based on the literature.
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before the intervention, immediately after the intervention, and at a two-week follow-up
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Tracheal Aspiration Skill Checklist
Time Frame: before the intervention, immediately after the intervention, and at a two-week follow-up
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Is there a significant difference in students' tracheal aspiration skill levels between applications performed with a high-fidelity simulator, a hybrid simulator, and a skill dummy?
The Tracheal Aspiration Skills Checklist consists of three sections: pre-aspiration, implementation, and post-procedure evaluation.
Each step is scored as "performed correctly" (2 points), "performed incompletely/incorrectly" (1 point), or "not performed" (0 points).
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before the intervention, immediately after the intervention, and at a two-week follow-up
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Student Satisfaction and Self-Confidence in Learning Scale
Time Frame: before the intervention, immediately after the intervention, and at a two-week follow-up
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How do different simulation methods affect students' satisfaction and self-confidence levels regarding tracheal aspiration procedures?
This scale measures students' satisfaction and self-confidence in learning within a simulation environment.
It consists of a total of 12 items.
Each item is rated on a five-point Likert scale, where 1 represents the lowest score and 5 represents the highest score.
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before the intervention, immediately after the intervention, and at a two-week follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Simulation Design Scale
Time Frame: immediately after the intervention
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The scale consists of two sections.
The first section evaluates whether the best practice simulation design elements were implemented during the simulation, while the second section assesses the degree to which the simulation experience is important for students.
The scale includes five subscales and a total of 20 items.
Each item is evaluated in two ways.
In the first section, responses range from "Strongly Disagree," "Disagree," "Undecided," "Agree," "Strongly Agree," to "Not Applicable."
In the second section, which measures the importance of the simulation for students, responses range from "Not Important," "Somewhat Important," "Undecided," "Important," to "Very Important."
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immediately after the intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 2026-KTUHEM-61
- TÜBİTAK (Other Identifier: The Scientific and Technological Research Council of Türkiye (TÜBİTAK))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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