NCT07262424

Brief Summary

Simulation is a cornerstone of health sciences education, with debriefing being its most critical component for fostering clinical skills. While various debriefing styles exist, there is limited evidence comparing the effectiveness of instructor-centered (ICT) versus learner-centered (LCT) approaches, specifically on the development of clinical judgment in nursing students.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Start

First participant enrolled

October 10, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

November 17, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

Clinical JudgmentLearner-Centered TeachingInstructor-Centered TeachingMixed-Methods StudyDebriefingNursing EducationSimulationRandomized Controlled TrialUndergraduate Health Education

Outcome Measures

Primary Outcomes (1)

  • Change in Clinical Judgment Assessed by the Lasater Clinical Judgment Rubric (LCJR)

    Assessment is performed using the Lasater Clinical Judgment Rubric (LCJR), a validated 11-item tool. During a standardized practical exam (OSCE), trained evaluators will use novel structured checklists developed by the investigators for this study. A unique checklist has been specifically tailored for each OSCE scenario, designed to operationalize the LCJR by mapping observable student behaviors directly to its scoring criteria. Each item is rated on a 4-point scale (1=beginning to 4=exemplary), yielding a total score from 11 to 44. A higher score indicates a more developed level of clinical judgment. For statistical analysis, the raw score will be transformed to a 0-10 scale.

    Assessed at two time points: at Baseline (measurement taken during the first-term practical exam, prior to the intervention) and Post-Intervention (measurement taken during the final practical exam, approximately 3 months after the baseline assessment).

Secondary Outcomes (1)

  • Student Perceptions of the Learning Experience Assessed by Focus Group Topic Guide

    Up to 3 weeks after the final simulation session.

Study Arms (2)

Learner-Centered Debriefing (LCT)

EXPERIMENTAL

Participants in this group will receive a debriefing guided by a learner-centered (LCT) style, where learning is a dynamic process of meaning-making, and both learners and instructors collaborate in the co-construction of knowledge, skills, and attitudes.

Behavioral: Learner-Centered Debriefing

Instructor-Centered Debriefing (ICT)

ACTIVE COMPARATOR

Participants in this group will receive a debriefing guided by an instructor-centered (ICT) style, which prioritizes the efficient transfer of information from instructors (who control the learning environments) to learners.

Behavioral: Instructor-Centered Debriefing

Interventions

Two 2-hour simulation sessions followed by an instructor-centered debriefing conducted by a trained facilitator. This style is the standard practice at the institution and focuses on direct feedback and information transfer from the instructor.

Instructor-Centered Debriefing (ICT)

Two 2-hour simulation sessions followed by a learner-centered debriefing conducted by a trained facilitator. This style emphasizes guided reflection and co-construction of knowledge.

Learner-Centered Debriefing (LCT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Students enrolled in the Basic Simulation Labs 2 (LBS2) course as part of their program.

You may not qualify if:

  • Students who cannot participate in all phases of the study.
  • Students who do not provide informed consent.
  • Students who are repeating the course.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International University of Catalonia

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

Related Publications (3)

  • Eppich W, Cheng A. Promoting Excellence and Reflective Learning in Simulation (PEARLS): development and rationale for a blended approach to health care simulation debriefing. Simul Healthc. 2015 Apr;10(2):106-15. doi: 10.1097/SIH.0000000000000072.

    PMID: 25710312BACKGROUND
  • Roman-Cereto M, Garcia-Mayor S, Kaknani-Uttumchandani S, Garcia-Gamez M, Leon-Campos A, Fernandez-Ordonez E, Ruiz-Garcia ML, Marti-Garcia C, Lopez-Leiva I, Lasater K, Morales-Asencio JM. Cultural adaptation and validation of the Lasater Clinical Judgment Rubric in nursing students in Spain. Nurse Educ Today. 2018 May;64:71-78. doi: 10.1016/j.nedt.2018.02.002. Epub 2018 Feb 9.

    PMID: 29459195BACKGROUND
  • Cheng A, Morse KJ, Rudolph J, Arab AA, Runnacles J, Eppich W. Learner-Centered Debriefing for Health Care Simulation Education: Lessons for Faculty Development. Simul Healthc. 2016 Feb;11(1):32-40. doi: 10.1097/SIH.0000000000000136.

    PMID: 26836466BACKGROUND

Central Study Contacts

Aleix Lopez Oganissian, MsC, PhDCandidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC, PhdCandidate

Study Record Dates

First Submitted

November 17, 2025

First Posted

December 3, 2025

Study Start

October 10, 2025

Primary Completion

March 1, 2026

Study Completion

May 1, 2026

Last Updated

December 9, 2025

Record last verified: 2025-12

Locations