- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07399366
Film-Based Medical Education and Social Justice Course: Effects on Alexithymia and Empathy in Medical Students
Effect of a Film-Based "Medical Education and Social Justice" Elective on Medical Students' Alexithymia Levels and Empathy Skills: A Nonrandomized Controlled Pretest-Posttest Study
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a prospective, nonrandomized controlled pretest-posttest study conducted at Canakkale Onsekiz Mart University Faculty of Medicine. Participants are volunteer medical students (≥18 years). The intervention group consists of students who enroll in the elective course, and the comparison group consists of students from the same student population who do not enroll during the same period.
Data will be collected at two time points: baseline prior to the start of the elective period (T0) and immediately after the end of the elective period (T1, approximately 14 weeks later). At each time point, participants will complete the study instruments administered in a standardized manner. In the intervention group, reflective journals will also be collected throughout the course period to support qualitative interpretation of findings.
The primary analysis will compare within-group change from T0 to T1 and between-group differences in change scores. Descriptive statistics will summarize participant characteristics. Depending on data distribution, paired tests and independent-group tests (or their nonparametric equivalents) will be used for continuous outcomes. Multivariable models may be used to adjust for baseline differences (e.g., class year) if imbalance is observed. Missing data will be handled using a predefined approach (e.g., complete-case analysis with sensitivity checks). No clinical procedures or medical treatments are involved.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Çanakkale
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Çanakkale, Çanakkale, Turkey (Türkiye), 17100
- Faculty of medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Enrolled medical student at Canakkale Onsekiz Mart University Faculty of Medicine, registered in Year 1, 2, or 3 during the study period.
- Age 18 years or older.
- Provides written/electronic informed consent after being informed about the study.
- For the intervention arm: enrolled in the elective "Film-Based Medical Education and Social Justice" course.
- For the control arm: from the same academic year/cohort during the same period and not enrolled in the elective course.
- Willing and able to complete both baseline (T0) and end-of-course (T1) assessments (has sufficient cognitive/communication ability to complete questionnaires).
Exclusion Criteria:
- Does not provide consent or withdraws consent at any stage.
- Younger than 18 years.
- Does not complete at least one of the two assessments (T0 or T1).
- Leaves critical sections of the questionnaires/assessments largely blank (e.g., substantial missing items on TAS-20 or incomplete scenario responses preventing scoring).
- Duplicate/duplicate submission (more than one form from the same participant for the same assessment).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Film-Based Medical Education and Social Justice Elective
Participants enrolled in the elective "Film-Based Medical Education and Social Justice" course.
The course is delivered over one semester (~14 weeks) and uses selected films/film clips with structured group discussion and reflection activities.
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A 14-week elective course (approximately 2 hours/week) using selected films/film clips with structured group discussion and reflective activities/journaling.
Other Names:
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No Intervention: No Course / Usual Curriculum
Participants who do not enroll in the elective course during the same period and continue usual curriculum without additional sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Toronto Alexithymia Scale (TAS-20) Total and Subscale Scores (Change)
Time Frame: Baseline (T0) and end of course (T1, approximately 14 weeks)
|
Change in TAS-20 total score and subscale scores (Difficulty Identifying Feelings, Difficulty Describing Feelings, Externally Oriented Thinking).
Higher scores indicate higher alexithymia.
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Baseline (T0) and end of course (T1, approximately 14 weeks)
|
|
Scenario-Based Empathy Skills Total Score and Rubric Subscores (Change)
Time Frame: Baseline (T0) and end of course (T1, approximately 14 weeks)
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Change in total empathy skills score derived from responses to study-developed scenarios scored with a rubric based on Dökmen's staged empathy classification; includes rubric subscores/levels if applicable.
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Baseline (T0) and end of course (T1, approximately 14 weeks)
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Jefferson Scale of Empathy S(tudent)-Version
Time Frame: Baseline (T0) and end of course (T1, approximately 14 weeks)
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JSE-S is a self-administered 20-item questionnaire scored on a 7-point Likert scale (1=strongly disagree to 7=strongly agree).
Total score is the sum of item scores (range 20-140); higher scores indicate higher empathy.
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Baseline (T0) and end of course (T1, approximately 14 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association Between Change in TAS-20 and Change in Empathy Score
Time Frame: From baseline (T0) to end of course (T1, approximately 14 weeks)
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Correlation/association between ΔTAS-20 (T1-T0) and ΔEmpathy (T1-T0) (Pearson or Spearman depending on distribution).
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From baseline (T0) to end of course (T1, approximately 14 weeks)
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Jefferson Scale of Empathy - Student Version (JSE-S) Subscale/Factor Scores (Change)
Time Frame: Baseline (T0) and end of course (T1, approximately 14 weeks)
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Change in JSE-S factor/subscale scores (e.g., Perspective Taking, Compassionate Care, Standing in Patient's Shoes; if applicable per scoring approach used).
Higher scores indicate higher empathy.
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Baseline (T0) and end of course (T1, approximately 14 weeks)
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Association Between JSE-S Score and Scenario-Based Empathy Skills Score (Convergent Validity)
Time Frame: Baseline (T0) and end of course (T1, approximately 14 weeks)
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Correlation/association between JSE-S total score and Scenario-Based Empathy Skills total score at T0 and at T1 (Pearson or Spearman depending on distribution), and/or association between change scores (ΔJSE-S vs ΔScenario score).
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Baseline (T0) and end of course (T1, approximately 14 weeks)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reflective Journal Themes (Intervention Group Only)
Time Frame: After each session during the course period (approximately 14 weeks); analyzed after T1
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De-identified reflective journals collected after sessions will be analyzed using thematic/content analysis to contextualize and deepen interpretation of quantitative findings.
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After each session during the course period (approximately 14 weeks); analyzed after T1
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Collaborators and Investigators
Investigators
- Study Chair: Mustafa Onur Yurdal, PhD, Canakkale Onsekiz Mart University
Publications and helpful links
General Publications
- Bagby RM, Parker JD, Taylor GJ. The twenty-item Toronto Alexithymia Scale- I. J Psychosom Res. 1994;38(1):23-32. PMID: 8126686. doi: 10.1016/0022-3999(94)90005-1. Law M, Kwong W, Friesen F, Veinot P, Ng SL. The current landscape of television and movies in medical education. Perspect Med Educ. 2015;4(5):218-224. doi: 10.1007/s40037-015-0205-9. Lumlertgul N, Kijpaisalratana N, Pityaratstian N, Wangsaturaka D. Cinemeducation: A pilot student project using movies to help students learn medical professionalism. Med Teach. 2009;31(7):e327-e332. PMID: 19811142. doi: 10.1080/01421590802637941. Rueb M, Siebeck M, Rehfuess EA, Pfadenhauer LM. Cinemeducation in medicine: a mixed methods study on students' motivations and benefits. BMC Med Educ. 2022;22:172. doi: 10.1186/s12909-022-03240-x. Salajegheh M, Sohrabpour AA, Mohammadi E. Exploring medical students' perceptions of empathy after cinemeducation based on Lev Vygotsky's theory. BMC Med Educ. 2024;24:94. doi: 10.1186/s12909-024-05084-z.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-YÖNP-0418
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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