Impact of Concept Mapping in Case-Based Learning Among Medical Students

June 7, 2026 updated by: Ben marzouk Sofiene, University Tunis El Manar

Impact of Concept Mapping and Its Integration Modality in Case-Based Learning on Knowledge Acquisition, Knowledge Retention, and Clinical Reasoning Development Among Third-Year Medical Students: A Prospective Randomized Study

This prospective randomized study aims to compare the impact of three Case-Based Learning (CBL) approaches on knowledge acquisition, knowledge retention, and clinical reasoning development among third-year medical students during their obstetrics and gynecology rotation.

Participants are randomly assigned to one of three groups: CBL without concept mapping, CBL with a teacher-constructed concept map, or CBL with a concept map co-constructed by students during the learning session. Knowledge acquisition and retention are assessed using pre-tests, immediate post-tests, and delayed post-tests. Clinical reasoning and knowledge organization are evaluated using a synthesis exercise.

The study seeks to determine whether concept mapping and the modality of its integration into CBL enhance learning outcomes and clinical reasoning skills in undergraduate medical education.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Case-Based Learning (CBL) is a learner-centered educational approach that promotes active learning and clinical reasoning through the discussion of authentic clinical cases. Concept maps are educational tools that help learners organize, integrate, and connect knowledge.

This prospective randomized study was conducted among third-year medical students during their obstetrics and gynecology rotation at the Maternity and Neonatology Center of Tunis. Eligible students who had reviewed the official preeclampsia learning module were randomly allocated to one of three educational interventions:

  1. Case-Based Learning without concept mapping.
  2. Case-Based Learning with a concept map designed by the instructor and presented at the end of the session.
  3. Case-Based Learning with a concept map progressively developed by students under instructor supervision.

All groups were exposed to the same clinical case, learning objectives, instructor, and teaching duration. Learning outcomes were assessed using a pre-test, an immediate post-test, a delayed post-test administered two weeks later, and a synthesis exercise evaluating knowledge organization and clinical reasoning.

The primary outcome is the effect of concept mapping and its integration modality on clinical reasoning and knowledge organization, assessed through the synthesis exercise score. Secondary outcomes include knowledge acquisition and knowledge retention assessed through test scores and score variations over time.

The findings of this study may contribute to identifying effective educational strategies for improving learning and clinical reasoning in undergraduate medical education.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia
        • Maternity and Neonatology Center of Tunis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Third-year medical students enrolled in the Obstetrics and Gynecology rotation.
  • Completion of the preeclampsia learning module before the educational session.
  • Provision of informed consent.

Exclusion Criteria:

  • Refusal to participate.
  • Failure to complete the pre-test, post-test, synthesis assessment, or delayed -post-test.
  • Absence from the educational session.
  • Incomplete study data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CBL Without Concept Mapping
Participants receive a Case-Based Learning session without the use of concept mapping.
Behavioral: Case-Based Learning Without Concept Mapping
Participants receive a Case-Based Learning session without the use of concept mapping.
Experimental: CBL With Teacher-Constructed Concept Map
Participants receive a Case-Based Learning session supplemented by a concept map prepared and presented by the instructor.
Behavioral: Teacher-Constructed Concept Mapping
Participants receive a Case-Based Learning session supplemented by a concept map designed and presented by the instructor.
Experimental: CBL With Student Co-Constructed Concept Map
Participants receive a Case-Based Learning session supplemented by a concept map progressively developed by students under instructor supervision.
Behavioral: Student Co-Constructed Concept Mapping
Participants receive a Case-Based Learning session supplemented by a concept map progressively developed by students under instructor supervision.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Reasoning Score
Time Frame: Immediately after completion of the Case-Based Learning session
Assessment of knowledge organization and clinical reasoning development using the synthesis question score (NQS)
Immediately after completion of the Case-Based Learning session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge Acquisition Score
Time Frame: Immediately after completion of the learning session
Difference between immediate post-test and pre-test scores (Δ1 = N2 - N1).
Immediately after completion of the learning session
Knowledge Retention Score
Time Frame: Two weeks after completion of the learning session
Delayed post-test score and score variation between delayed and immediate post-tests (Δ2 = N3 - N2).
Two weeks after completion of the learning session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Tunis El Manar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CBL/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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