NCT07435558

Brief Summary

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. The 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. This 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. Registered 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. The 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. The 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

March 7, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 22, 2026

Last Update Submit

February 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Medication Safety Competence

    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.

    Baseline (T0), Immediately Post-Intervention (within 1 week after final session, T1), and 8 Weeks Post-Intervention (T2)

Secondary Outcomes (2)

  • Clinical Reasoning Competence

    Baseline (T0), Immediately Post-Intervention (T1), and 8 Weeks Post-Intervention (T2)

  • Nursing Care Quality

    Baseline (T0), Immediately Post-Intervention (T1), and 8 Weeks Post-Intervention (T2)

Study Arms (2)

Homogeneous FSLSM-Based Grouping

EXPERIMENTAL

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.

Behavioral: Homogeneous FSLSM-Based PBL Grouping

Heterogeneous FSLSM-Based Grouping

EXPERIMENTAL

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.

Behavioral: Heterogeneous FSLSM-Based PBL Grouping

Interventions

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.

Homogeneous FSLSM-Based Grouping

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.

Heterogeneous FSLSM-Based Grouping

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent;
  • at least one year of clinical nursing experience;
  • availability to attend all scheduled workshop sessions (no planned extended leave during the intervention period);
  • completion of the Index of Learning Styles (ILS) questionnaire and availability of valid ILS scores for group allocation

You may not qualify if:

  • attendance in a similar PBL or patient-safety educational program within the previous 6-12 months;
  • significant uncorrectable hearing or vision impairment or severe cognitive/psychiatric condition that precluded participation;
  • concurrent participation in another interventional study likely to affect study outcomes;
  • repeated non-attendance (\>2 missed sessions) or voluntary withdrawal after randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start

March 7, 2026

Primary Completion

June 30, 2026

Study Completion

July 15, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02