Simulation TrainingExperimentalNCT07435233
Different Reality Simulation Education Methods on Nursing Students
A study testing High-Fidelity Simulation, Hybrid Simulation and Training mannequin in people with Simulation Training, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
To compare the impact of simulation practices using a high-reality simulator, hybrid simulator and task-trainers on tracheal aspiration levels of nursing students' knowledge, skills, satisfaction, and self-confidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Simulation Training
- What is being tested?
- High-Fidelity Simulation, Hybrid Simulation and Training mannequin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 5 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
To compare the impact of simulation practices using a high-reality simulator, hybrid simulator and task-trainers on tracheal aspiration levels of nursing students' knowledge, skills, satisfaction, and self-confidence.
Read the detailed description
The study will be conducted as a randomized controlled experimental study to compare the impact of simulation practices using a high-reality simulator, hybrid simulator and task-trainers on tracheal aspiration levels of nursing students' knowledge, skills, satisfaction, and self-confidence. The project's goal is to learn a simulation scenario, which is the application of tracheal aspiration. The nursing students in Experimental 1 group will be trained with a high-reality simulator, the Experimental 2 group with a hybrid simulator with simulation applications and the Control group with the skill machete as a routine practice.
- Conditions
- Simulation Training
- Being tested
- High-Fidelity Simulation, Hybrid Simulation, Training mannequin
- Keywords
- Nursing education, simulation technics, tracheal aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Fidelity SimulationOther
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.
Hybrid SimulationOther
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.
Training mannequinOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Group 1: High-Fidelity Simulation Group | Experimental | 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. Receives: Other: High-Fidelity Simulation |
| Experimental: Group 2: Hybrid Simulation Group | Experimental | 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. Receives: Other: Hybrid Simulation |
| Control Group: Routine Skills Training Group | Other | 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. Receives: Other: Training mannequin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracheal Aspiration Knowledge Test
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.
Measured: before the intervention, immediately after the intervention, and at a two-week follow-up
Tracheal Aspiration Skill Checklist
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).
Measured: before the intervention, immediately after the intervention, and at a two-week follow-up
Student Satisfaction and Self-Confidence in Learning Scale
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.
Measured: before the intervention, immediately after the intervention, and at a two-week follow-up
Secondary outcomes (1)
Simulation Design Scale
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."
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jan 2026
- Primary completion5 May 2026 (estimated)
- Study completion5 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation TrainingStudies of the same condition, open and under way.
- 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
- Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysun Bayram, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435233
- Sponsor's protocol ID
- 2026-KTUHEM-61
- Other IDs
- TÜBİTAK
- Acronym
- Experimental
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07435233
- Acronym / sponsor ID
- Experimental / 2026-KTUHEM-61
- Conditions
- Simulation Training
- Keywords
- Nursing education, simulation technics, tracheal aspiration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 5 Mar 2027 (estimated)
- First posted
- 27 Feb 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.
To compare the impact of simulation practices using a high-reality simulator, hybrid simulator and task-trainers on tracheal aspiration levels of nursing students' knowledge, skills, satisfaction, and self-confidence.
Detailed description
The study will be conducted as a randomized controlled experimental study to compare the impact of simulation practices using a high-reality simulator, hybrid simulator and task-trainers on tracheal aspiration levels of nursing students' knowledge, skills, satisfaction, and self-confidence. The project's goal is to learn a simulation scenario, which is the application of tracheal aspiration. The nursing students in Experimental 1 group will be trained with a high-reality simulator, the Experimental 2 group with a hybrid simulator with simulation applications and the Control group with the skill machete as a routine practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group 1: High-Fidelity Simulation Group | Experimental | Other: High-Fidelity SimulationExperimental 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. |
| Experimental: Group 2: Hybrid Simulation Group | Experimental | Other: Hybrid SimulationExperimental 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. |
| Control Group: Routine Skills Training Group | Other | Other: Training mannequinControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| High-Fidelity SimulationIt 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. | Other | Experimental: Group 1: High-Fidelity Simulation Group |
| Hybrid SimulationThis 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. | Other | Experimental: Group 2: Hybrid Simulation Group |
| Training mannequinThe 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. | Other | Control Group: Routine Skills Training Group |
Primary outcome
Tracheal Aspiration Knowledge Test
Time frame: before the intervention, immediately after the intervention, and at a two-week follow-up
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.
Tracheal Aspiration Skill Checklist
Time frame: before the intervention, immediately after the intervention, and at a two-week follow-up
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).
Student Satisfaction and Self-Confidence in Learning Scale
Time frame: before the intervention, immediately after the intervention, and at a two-week follow-up
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.
1 secondary outcome
Simulation Design Scale
Time frame: immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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 High-Fidelity Simulation, Hybrid Simulation and Training mannequin in people with Simulation Training, run by Karadeniz Technical University 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 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 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?
This study is still under way. Results are not available in the source record yet.
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?
Tracheal Aspiration Knowledge Test (time frame: before the intervention, immediately after the intervention, and at a two-week follow-up). 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 27 Feb 2026.