Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:49 PM
Study NCT ID:
NCT07448168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Standardized Patient Simulation on Nursing Students' Assessment, Diagnosis Skills, and Experiences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into simulation and traditional education groups, and outcomes will be compared between groups.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nursing Assessment Skill Score', 'timeFrame': 'Pre-test (baseline) and post-test (after completion of training, approximately 1 week).', 'description': "Students' nursing assessment skills will be evaluated using the Nursing Assessment Evaluation Form developed by the researchers. Higher scores indicate better assessment performance."}], 'secondaryOutcomes': [{'measure': 'Nursing Diagnosis Determination Skill Score', 'timeFrame': 'Pre-test (baseline) and post-test (after completion of training, approximately 1 week).', 'description': "Students' ability to determine accurate nursing diagnoses will be evaluated using a standardized diagnosis evaluation checklist. Higher scores indicate greater diagnostic accuracy."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nursing assessment', 'Nursing diagnosis', 'Nursing process', 'Nursing students', 'Simulation training', 'Standardised patient'], 'conditions': ["Nurse's Role"]}, 'descriptionModule': {'briefSummary': "This randomized controlled study aims to determine the effect of teaching delivered through standardized patient simulation on nursing students' assessment and nursing diagnosis determination skills, as well as their learning experiences. First-year nursing students will be randomly assigned to intervention and control groups. The intervention group will receive training based on standardized patient simulation, while the control group will receive traditional instruction. Data will be collected using a sociodemographic information form, case-based assessment tools, and measurement instruments designed to evaluate students' perceptions and experiences related to the educational process. Group comparisons will be conducted to evaluate the effectiveness of the simulation-based teaching method.", 'detailedDescription': "The nursing process is a fundamental component of the bachelor's degree nursing program and plays a critical role in developing students' skills in systematic data collection, analysis, and nursing diagnosis, particularly during the first year of education. Traditional teaching methods may be insufficient to support the development of clinical reasoning and decision-making skills. Therefore, standardized patient simulation, an active learning strategy, is recognized as an effective approach to holistically develop students' cognitive, psychomotor, and affective competencies.\n\nThis randomized controlled trial will be conducted with first-year nursing students. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive education based on standardized patient simulation focusing on the first two steps of the nursing process: nursing assessment and nursing diagnosis. The control group will receive the same theoretical content through traditional teaching methods.\n\nThe primary outcome measures of the study are the students' nursing assessment and nursing diagnosis skills. The secondary outcome measure is the students' experiences and perceptions of the educational process. Data will be collected before and after the intervention using appropriate measurement tools. The collected data will be analyzed using appropriate statistical methods to compare the differences."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First-year nursing student\n* Successfully completed the Fundamentals of Nursing I course\n* Currently enrolled in the Fundamentals of Nursing II course\n* Aged 18 years or older\n* Voluntary agreement to participate in the study\n\nExclusion Criteria:\n\n* Previously completed the Fundamentals of Nursing II course\n* Withdrawal from the study for any reason\n* Failure to complete the post-test assessment'}, 'identificationModule': {'nctId': 'NCT07448168', 'briefTitle': "Effect of Standardized Patient Simulation on Nursing Students' Assessment, Diagnosis Skills, and Experiences", 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': "The Effect of Teaching With Standardized Patient Simulation on Students' Assessment and Nursing Diagnosis Determination Skills and Determination of Their Experiences", 'orgStudyIdInfo': {'id': '2025/44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standardized Patient Simulation-Based Training Group', 'description': 'Participants in this group will receive training based on standardized patient simulation focused on nursing assessment and nursing diagnosis skills.', 'interventionNames': ['Behavioral: Standardized Patient Simulation-Based Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Training Group', 'description': 'Participants in this group will receive traditional training in nursing assessment and determining nursing diagnoses.', 'interventionNames': ['Behavioral: Traditional Training']}], 'interventions': [{'name': 'Standardized Patient Simulation-Based Training', 'type': 'BEHAVIORAL', 'description': "This intervention consists of structured training sessions using standardized patient simulation scenarios. The training focuses on developing students' nursing assessment and nursing diagnosis skills through active participation, scenario-based practice, and evaluation meetings.", 'armGroupLabels': ['Standardized Patient Simulation-Based Training Group']}, {'name': 'Traditional Training', 'type': 'BEHAVIORAL', 'description': 'This intervention consists of traditional lecture and case-based education focused on nursing assessment and nursing diagnosis determination.', 'armGroupLabels': ['Traditional Training Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fulya Batmaz, RN, MSc,', 'role': 'CONTACT', 'email': 'fulya.batmaz@ktu.edu.tr', 'phone': '+9004623771191'}], 'overallOfficials': [{'name': 'Fulya Batmaz, PhD(c)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karadeniz Technical University, Faculty of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate in Nursing', 'investigatorFullName': 'Fulya Batmaz', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}