Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:30 AM
Study NCT ID:
NCT07435558
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Homogeneous vs. Heterogeneous Learning Style Grouping in Problem-Based Learning Among Nurses
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication Safety Competence', 'timeFrame': 'Baseline (T0), Immediately Post-Intervention (within 1 week after final session, T1), and 8 Weeks Post-Intervention (T2)', 'description': 'Medication safety competence is measured using the Persian version of the Medication Safety Competence Scale (MSCS), a 36-item self-report questionnaire assessing skills related to medication error prevention, accurate drug calculation and administration, identification of drug interactions, and error reporting. Items are rated on a 5-point Likert scale. Total scores range from 36 to 180, with higher scores indicating greater medication safety competence.'}], 'secondaryOutcomes': [{'measure': 'Clinical Reasoning Competence', 'timeFrame': 'Baseline (T0), Immediately Post-Intervention (T1), and 8 Weeks Post-Intervention (T2)', 'description': 'Clinical reasoning competence is measured using the Persian version of the Clinical Reasoning Competence Scale for Nurses (CRCSN). This 22-item instrument evaluates three domains: Plan Setting, Intervention Strategy Regulation, and Self-Instruction. Items are rated on a 5-point Likert scale. Higher total scores indicate greater clinical reasoning competence.'}, {'measure': 'Nursing Care Quality', 'timeFrame': 'Baseline (T0), Immediately Post-Intervention (T1), and 8 Weeks Post-Intervention (T2)', 'description': 'Nursing care quality is measured using the Persian version of the Nursing Care Quality Scale (CNCQS), a 35-item self-report instrument covering six domains: patient outcomes, ethical activities, nursing task requirements, nurse characteristics, nursing process advancement, and physical environment. Items are rated on a 5-point Likert scale. Total scores range from 35 to 175, with higher scores indicating better perceived nursing care quality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Problem-based Learning in Nursing Education', 'Nurses', 'Randomized Clinical Trial']}, 'descriptionModule': {'briefSummary': 'Problem-based learning (PBL) is a learner-centered educational approach that helps nurses improve clinical skills through group discussion, case analysis, and collaborative problem-solving. However, the way participants are assigned to learning groups may influence how effectively they learn. Differences in learning styles among group members can affect participation, confidence, interaction quality, and knowledge retention.\n\nThe Felder-Silverman Learning Style Model (FSLSM) is a widely used framework that categorizes learners based on how they perceive, process, and understand information (e.g., active vs. reflective, visual vs. verbal). Organizing PBL groups according to similarities or differences in these learning styles may lead to different educational outcomes.\n\nThis study is a parallel, two-arm randomized controlled clinical trial designed to compare the effects of homogeneous grouping (participants with similar learning styles placed in the same group) versus heterogeneous grouping (participants with diverse learning styles placed in the same group) on PBL outcomes among hospital nurses.\n\nRegistered nurses employed in teaching hospitals affiliated with Shahid Beheshti University of Medical Sciences are randomly assigned to one of the two grouping strategies. All participants receive the same PBL curriculum focused on patient safety and medication safety. The only difference between groups is the method used to form discussion teams.\n\nThe primary outcome is medication safety competence, measured using a validated questionnaire. Secondary outcomes include clinical reasoning competence and nursing care quality. Outcomes are assessed at baseline, immediately after the intervention, and eight weeks later to evaluate both immediate effects and short-term retention.\n\nThe findings of this study are expected to clarify whether grouping nurses based on similar or diverse learning styles leads to better improvement and retention of critical clinical competencies. Results may help educators design more effective PBL programs in nursing education and clinical training settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. written informed consent;\n2. at least one year of clinical nursing experience;\n3. availability to attend all scheduled workshop sessions (no planned extended leave during the intervention period);\n4. completion of the Index of Learning Styles (ILS) questionnaire and availability of valid ILS scores for group allocation\n\nExclusion Criteria:\n\n1. attendance in a similar PBL or patient-safety educational program within the previous 6-12 months;\n2. significant uncorrectable hearing or vision impairment or severe cognitive/psychiatric condition that precluded participation;\n3. concurrent participation in another interventional study likely to affect study outcomes;\n4. repeated non-attendance (\\>2 missed sessions) or voluntary withdrawal after randomization.'}, 'identificationModule': {'nctId': 'NCT07435558', 'briefTitle': 'Homogeneous vs. Heterogeneous Learning Style Grouping in Problem-Based Learning Among Nurses', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Effect of Homogeneous and Heterogeneous Grouping Based on the Felder-Silverman Learning Style Model on Problem-Based Learning Outcomes Among Nurses: A Parallel Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'IR.SBMU.PHARMACY.REC.1404.253'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Homogeneous FSLSM-Based Grouping', 'description': 'Participants receive a standardized problem-based learning (PBL) curriculum on patient safety and medication safety. Discussion groups are formed using a homogeneous grouping strategy based on the Felder-Silverman Learning Style Model (FSLSM). Nurses are assigned to 7-member groups in which members share similar learning style preferences in at least three of the four FSLSM dimensions (Active/Reflective; Sensing/Intuitive; Visual/Verbal; Sequential/Global). All educational content, cases, facilitators, and session formats are identical to the comparison arm; only the group formation strategy differs.', 'interventionNames': ['Behavioral: Homogeneous FSLSM-Based PBL Grouping']}, {'type': 'EXPERIMENTAL', 'label': 'Heterogeneous FSLSM-Based Grouping', 'description': 'Participants receive the same standardized problem-based learning (PBL) curriculum as the comparison arm. Discussion groups are formed using a heterogeneous grouping strategy based on the Felder-Silverman Learning Style Model (FSLSM). Nurses are assigned to 7-member groups designed to maximize diversity of learning styles across the four FSLSM dimensions. The only difference between study arms is the method of group formation.', 'interventionNames': ['Behavioral: Heterogeneous FSLSM-Based PBL Grouping']}], 'interventions': [{'name': 'Homogeneous FSLSM-Based PBL Grouping', 'type': 'BEHAVIORAL', 'description': 'An 8-session problem-based learning workshop delivered over six weeks focusing on patient safety culture, medication safety, root cause analysis, human factors, team communication, error disclosure, and risk management. Groups are formed to ensure similarity in learning style profiles according to Index of Learning Styles (ILS) scores. Sessions include case discussions, role-play, team-based tasks, brief simulations, and group presentations. Facilitators follow standardized guides.', 'armGroupLabels': ['Homogeneous FSLSM-Based Grouping']}, {'name': 'Heterogeneous FSLSM-Based PBL Grouping', 'type': 'BEHAVIORAL', 'description': 'An 8-session problem-based learning workshop delivered over six weeks focusing on patient safety and related competencies. Group composition is determined using an Artificial Bee Colony optimization algorithm to maximize diversity of learning style profiles while maintaining balance across groups. Educational materials, facilitators, and learning activities are identical to the homogeneous arm.', 'armGroupLabels': ['Heterogeneous FSLSM-Based Grouping']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'At this time, the study team has not yet decided whether individual participant data (IPD) will be shared. If sharing is planned in the future, the data will include de-identified clinical data collected during the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sogand Sarmadi', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}