Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-04 @ 9:45 PM
Study NCT ID:
NCT07435233
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Reality Simulation Education Methods on Nursing Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'To ensure objective evaluation, investigators, selected solely for monitoring purposes and excluded from the randomization process, will administer the pre-test, post-test, and retention tests. For blinding purposes, the observer will not know which group the student being monitored belongs to.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tracheal Aspiration Knowledge Test', 'timeFrame': 'before the intervention, immediately after the intervention, and at a two-week follow-up', 'description': "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."}, {'measure': 'Tracheal Aspiration Skill Checklist', 'timeFrame': 'before the intervention, immediately after the intervention, and at a two-week follow-up', 'description': '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).'}, {'measure': 'Student Satisfaction and Self-Confidence in Learning Scale', 'timeFrame': 'before the intervention, immediately after the intervention, and at a two-week follow-up', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Simulation Design Scale', 'timeFrame': 'immediately after the intervention', 'description': '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."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nursing education', 'simulation technics', 'tracheal aspiration'], 'conditions': ['Simulation Training']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being a first-year nursing student and currently continuing education,\n* Having attended the tracheal aspiration (TA) theoretical and laboratory training provided within the scope of this study,\n* Agreeing to participate in the study.\n\nExclusion Criteria:\n\n* Not having attended the TA theoretical and laboratory training provided within the scope of this study,\n* Having prior educational experience related to basic nursing skills,\n* Currently studying in or having graduated from a vocational health high school or any health-related high school, associate, or undergraduate program,\n* Refusing to participate in the study.'}, 'identificationModule': {'nctId': 'NCT07435233', 'acronym': 'Experimental', 'briefTitle': 'Different Reality Simulation Education Methods on Nursing Students', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': '2026-KTUHEM-61'}, 'secondaryIdInfos': [{'id': 'TÜBİTAK', 'type': 'OTHER', 'domain': 'The Scientific and Technological Research Council of Türkiye (TÜBİTAK)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Group 1: High-Fidelity Simulation Group', 'description': 'Experimental Group 1 (High-Fidelity Simulation Group):\n\nNursing 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.', 'interventionNames': ['Other: High-Fidelity Simulation']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Group 2: Hybrid Simulation Group', 'description': 'Experimental Group 2 (Hybrid Simulation Group):\n\nNursing students in this group will be trained using a hybrid simulation model that combines simulation-based applications with additional instructional components.', 'interventionNames': ['Other: Hybrid Simulation']}, {'type': 'OTHER', 'label': 'Control Group: Routine Skills Training Group', 'description': 'Control Group (Routine Skills Training Group):\n\nStudents in the control group will receive traditional skills training using a standard skills mannequin as part of routine laboratory practice.', 'interventionNames': ['Other: Training mannequin']}], 'interventions': [{'name': 'High-Fidelity Simulation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Experimental: Group 1: High-Fidelity Simulation Group']}, {'name': 'Hybrid Simulation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Experimental: Group 2: Hybrid Simulation Group']}, {'name': 'Training mannequin', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Control Group: Routine Skills Training Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Karadeniz Technical University', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Aysun Bayram', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}