Effect of a Community Service-Learning Intervention on Medical Empathy and Clinical Self-Efficacy in Medical Students (ApS-MED-IZT)

June 29, 2026 updated by: Luis Angel Flores Sagrero

Effect of a Community Service-Learning Intervention on Medical Empathy and Perceived Clinical Self-Efficacy in Fourth-Semester Medical Students at FES Iztacala, UNAM: A Quasi-Experimental Pre-Post Study

Medical empathy and clinical self-efficacy are key professional competencies that are difficult to develop through traditional classroom-based training alone. At the Faculty of Medicine of FES Iztacala (UNAM), the curriculum includes a community practice component in the Practica Clinica I module that is rarely implemented in practice, creating a gap between the formal and real curriculum.

This quasi-experimental pre-post study evaluates the effect of a structured Service-Learning (SL) intervention - a community anthropometry and somatometry assessment session conducted at a primary school - on medical empathy, perceived clinical self-efficacy, and clinical report performance in 35 fourth-semester medical students.

Medical empathy will be measured using the Jefferson Scale of Empathy, Student version (JSE-S), validated in Spanish for Latin American populations. Clinical self-efficacy will be measured using the Medical Self-Efficacy Scale (EAM), a 5-item Likert instrument developed by the principal investigator (Cronbach's alpha=0.818, McDonald's omega=0.862). Clinical performance will be assessed using a standardized 33-point rubric evaluated blindly by two independent faculty members, with inter-rater reliability calculated using the Intraclass Correlation Coefficient (ICC).

Children participating in the community session will receive a personalized health report with their anthropometric results and, if clinically relevant findings are detected, will be referred to the University Health Clinic (CUSI) at FES Iztacala at no cost.

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

BACKGROUND:

The Practica Clinica I module at FES Iztacala, UNAM, formally establishes three learning spaces: classroom, clinical, and community. However, systematic observation during the principal investigator's medical internship revealed that the community space is rarely operationalized, resulting in a significant gap between the formal and real curriculum. Students complete the module without real clinical contact with external patients, which limits the development of empathy and clinical self-efficacy.

THEORETICAL FRAMEWORK:

The intervention is grounded in Service-Learning pedagogy, Kolb's experiential learning cycle, Bandura's self-efficacy theory, and the medical empathy model by Hojat. The community activity at a primary school fulfills all constitutive elements of SL: a real community need (nutritional screening), structured learning objectives aligned with the curriculum, and mutual benefit for both students and the community.

INTERVENTION:

Participating medical students will conduct a full anthropometric and somatometric assessment of school-age children, including: weight, height, BMI calculation and interpretation using WHO/CDC reference tables, body circumferences (waist, hip, arm), body segments (armspan and others), and waist-hip ratio. Students will complete a simplified clinical history form and produce a written clinical report including findings interpretation and health recommendations. Each child's family will receive a sealed envelope with their personalized results. Children with clinically significant findings will be referred to CUSI (FES Iztacala).

MEASUREMENTS:

  • Medical empathy: JSE-S (20 items, 7-point Likert, range 20-140), applied pre and post intervention. Used with permission from Thomas Jefferson University.
  • Clinical self-efficacy: EAM (5 items, 5-point Likert, range 5-25), applied pre and post intervention.
  • Clinical report performance: standardized rubric (7 dimensions, 33 points), applied blindly by two independent faculty members to both the pre-intervention report (classroom peer practice) and post-intervention report (community real patient). ICC will be calculated before proceeding with comparisons.

STATISTICAL ANALYSIS:

Shapiro-Wilk normality test on pre-post differences. Paired t-test or Wilcoxon signed-rank test depending on normality. Cohen's d for effect size. Bonferroni correction for three simultaneous primary hypotheses (adjusted alpha=0.017). Pearson or Spearman correlation for the secondary hypothesis. Software: JASP and G*Power.

ETHICAL CONSIDERATIONS:

The study poses minimal risk. Informed consent will be obtained from all medical students. Parental informed consent and children's assent will be obtained for all school-age participants. The study will be submitted for ethical review to the Ethics Committee of FES Iztacala (CEI-FES Iztacala) prior to data collection. The JSE-S is used with written permission from Thomas Jefferson University (April 2025).

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.
35

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

  • Mexico
    • Mexico City
      • Tlalnepantla, Mexico City, Mexico, 54090
        • Facultad de Estudios Superiores Iztacala, UNAM

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:

  • Enrolled in the fourth semester of the Medico Cirujano (MD) program at FES Iztacala, UNAM
  • Registered in the Practica Clinica I module during the study period
  • Signed informed consent prior to any data collection
  • Present at both pre-intervention and post-intervention measurement sessions

Exclusion Criteria:

  • Previous enrollment in the Practica Clinica I module
  • Prior documented clinical experience outside the university setting (internships, clinical rotations in other programs)
  • Absence from the community intervention session for any reason
  • Failure to complete at least one of the three measurement instruments at either time point

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: N/A
  • Interventional Model: Single Group 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: Service-Learning Community Intervention
Fourth-semester medical students participate in a structured Service-Learning activity at a primary school, conducting anthropometric and somatometric assessments of school-age children. Measurements include weight, height, BMI, body circumferences, and body segments. Students complete a simplified clinical history and produce a written clinical report with findings interpretation and health recommendations.
Behavioral: Community Service-Learning Anthropometric Assessment
A single-session community Service-Learning activity conducted at Escuela Primaria Jesus Garcia (C.T. 15DPR1779L). Medical students perform weight, height, BMI, body circumferences (waist, hip, arm), body segments, and waist-hip ratio measurements on consenting school children. Students complete a simplified clinical history form and produce a written clinical report including anthropometric data, interpretation using WHO/CDC reference tables, relevant findings, and health recommendations. Each participating child's family receives a sealed personalized results envelope. Students with clinically significant findings are referred to CUSI (FES Iztacala). Duration: one full day. Supervised by faculty members from FES Iztacala.

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
Change in Medical Empathy Score (JSE-S)
Time Frame: Baseline and 5 weeks
Change from baseline in total score on the Jefferson Scale of Empathy, Student Version (JSE-S). Scale range: 20 to 140. Higher scores indicate greater medical empathy. Used with permission from Thomas Jefferson University.
Baseline and 5 weeks
Change in Perceived Clinical Self-Efficacy Score (EAM)
Time Frame: Baseline and 5 weeks
Change from baseline in total score on the Medical Self-Efficacy Scale (EAM), a 5-item Likert instrument developed by the principal investigator. Scale range: 5 to 25. Higher scores indicate greater perceived clinical self-efficacy. Cronbach's alpha=0.849, McDonald's omega=0.871.
Baseline and 5 weeks
Change in Clinical Report Performance Score (Standardized Rubric)
Time Frame: Baseline and 5 weeks

Change in total score on a 7-dimension, 33-point standardized rubric evaluating the clinical anthropometry report. Dimensions: basic anthropometric measurements, body circumferences, body segments, use of reference values, clinical interpretation, recommendations, and report structure. Evaluated blindly by two independent faculty members. Inter-rater reliability assessed with ICC (two-way absolute agreement model).

NOTE: Data for this outcome measure were not collected. The clinical report rubric evaluation was planned but could not be completed due to operational time constraints during the study period. Results for this outcome are not available.
Baseline and 5 weeks

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
Correlation Between Change in Medical Empathy and Change in Clinical Self-Efficacy (Pearson r)
Time Frame: 5 weeks
Pearson correlation coefficient between the change score (post minus pre) in JSE-S and the change score (post minus pre) in EAM, in participants with complete data on both instruments.
5 weeks

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.
Luis Angel Flores Sagrero

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad Nacional Autonoma de Mexico

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

  • Abreu-Hernández LF, León-Bórquez R. Una agenda para el cambio de la educación médica en México. Horizonte 2030. Investigación Educ Med. 2022;11(42):2-10.

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.
April 8, 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.
May 13, 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.
May 27, 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).
April 3, 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.
April 9, 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.
April 14, 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.
August 17, 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 29, 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

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.
  • FES-IZT-PC1-2025-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly to protect participant confidentiality, in compliance with the ethical approval conditions of the CEI-FES Iztacala and the informed consent agreements. Aggregated results will be reported in publications and/or the thesis document.

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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