AlexithymiaNCT07399366
Film-Based Medical Education and Social Justice Course: Effects on Alexithymia and Empathy in Medical Students
A study testing Film-Based Medical Education and Social Justice Elective in people with Alexithymia and Empathy Skills, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
This study will examine whether a 14-week elective course that uses films and guided discussion on social justice in health care can improve medical students' empathy skills and reduce alexithymia (difficulty recognizing and describing emotions). Approximately 50 volunteer medical students will participate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alexithymia, Empathy Skills, Education, Medical
- What is being tested?
- Film-Based Medical Education and Social Justice Elective
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Feb 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Faculty of Medicine
Çanakkale, Çanakkale, 17100
About this study
Official title: 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
This study will examine whether a 14-week elective course that uses films and guided discussion on social justice in health care can improve medical students' empathy skills and reduce alexithymia (difficulty recognizing and describing emotions). Approximately 50 volunteer medical students will participate. Students who choose the elective course will form the intervention group, and students who do not take the course will form a comparison group. All participants will complete the same questionnaires/assessments at the beginning and at the end of the semester. The main goal is to compare changes in empathy and alexithymia scores between the two groups.
Read the 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.
- Being tested
- Film-Based Medical Education and Social Justice Elective
- Keywords
- Film-based education, Cinema in medical education, CineMedicine, Narrative medicine, Social justice education
- Medical subject headings
- Affective Symptoms, Narrative Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Film-Based Medical Education and Social Justice ElectiveBehavioural
Also called Film-Based Medical Education and Social Justice Course
A 14-week elective course (approximately 2 hours/week) using selected films/film clips with structured group discussion and reflective activities/journaling.
| Study group | Role | What they receive |
|---|---|---|
| Film-Based Medical Education and Social Justice Elective | Experimental | 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. Receives: Behavioral: Film-Based Medical Education and Social Justice Elective |
| No Course / Usual Curriculum | No intervention | Participants who do not enroll in the elective course during the same period and continue usual curriculum without additional sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Alexithymia Scale (TAS-20) Total and Subscale Scores (Change)
Change in TAS-20 total score and subscale scores (Difficulty Identifying Feelings, Difficulty Describing Feelings, Externally Oriented Thinking). Higher scores indicate higher alexithymia.
Measured: Baseline (T0) and end of course (T1, approximately 14 weeks)
Scenario-Based Empathy Skills Total Score and Rubric Subscores (Change)
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.
Measured: Baseline (T0) and end of course (T1, approximately 14 weeks)
Jefferson Scale of Empathy S(tudent)-Version
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.
Measured: Baseline (T0) and end of course (T1, approximately 14 weeks)
Secondary outcomes (3)
Association Between Change in TAS-20 and Change in Empathy Score
Correlation/association between ΔTAS-20 (T1-T0) and ΔEmpathy (T1-T0) (Pearson or Spearman depending on distribution).
Measured: From baseline (T0) to end of course (T1, approximately 14 weeks)
Jefferson Scale of Empathy - Student Version (JSE-S) Subscale/Factor Scores (Change)
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.
Measured: Baseline (T0) and end of course (T1, approximately 14 weeks)
Association Between JSE-S Score and Scenario-Based Empathy Skills Score (Convergent Validity)
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).
Measured: Baseline (T0) and end of course (T1, approximately 14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start16 Feb 2026 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlexithymiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Nonrandomized allocation due to elective self-selection (students enroll in the course by choice); contemporaneous comparison group not enrolled.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Onur Yurdal, Çanakkale Onsekiz Mart University
- Investigators
- Mustafa Onur Yurdal, PhD, Study chair, Çanakkale Onsekiz Mart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399366
- Sponsor's protocol ID
- 2025-YÖNP-0418
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data (IPD) underlying the results reported in publications (e.g., TAS-20 total/subscale scores and scenario-based empathy scores at T0 and T1) will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary results, for up to 5 years. Requests will be reviewed by the study team and may require a data use agreement. Shared datasets will be de-identified and will not include direct identifiers; access will be limited to the minimum necessary to protect participant confidentiality.
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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07399366
- Acronym / sponsor ID
- 2025-YÖNP-0418
- Keywords
- Film-based education, Cinema in medical education, CineMedicine, Narrative medicine, Social justice education
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 16 Feb 2026 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine whether a 14-week elective course that uses films and guided discussion on social justice in health care can improve medical students' empathy skills and reduce alexithymia (difficulty recognizing and describing emotions). Approximately 50 volunteer medical students will participate. Students who choose the elective course will form the intervention group, and students who do not take the course will form a comparison group. All participants will complete the same questionnaires/assessments at the beginning and at the end of the semester. The main goal is to compare changes in empathy and alexithymia scores between the two groups.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Nonrandomized allocation due to elective self-selection (students enroll in the course by choice); contemporaneous comparison group not enrolled.
| Arm | Type | Receives |
|---|---|---|
| Film-Based Medical Education and Social Justice Elective | Experimental | Behavioral: Film-Based Medical Education and Social Justice ElectiveParticipants 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. |
| No Course / Usual Curriculum | No intervention | –Participants who do not enroll in the elective course during the same period and continue usual curriculum without additional sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Film-Based Medical Education and Social Justice ElectiveAlso: Film-Based Medical Education and Social Justice CourseA 14-week elective course (approximately 2 hours/week) using selected films/film clips with structured group discussion and reflective activities/journaling. | Behavioural | Film-Based Medical Education and Social Justice Elective |
Primary outcome
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.
Scenario-Based Empathy Skills Total Score and Rubric Subscores (Change)
Time frame: Baseline (T0) and end of course (T1, approximately 14 weeks)
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.
Jefferson Scale of Empathy S(tudent)-Version
Time frame: Baseline (T0) and end of course (T1, approximately 14 weeks)
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.
3 secondary outcomes
Association Between Change in TAS-20 and Change in Empathy Score
Time frame: From baseline (T0) to end of course (T1, approximately 14 weeks)
Jefferson Scale of Empathy - Student Version (JSE-S) Subscale/Factor Scores (Change)
Time frame: Baseline (T0) and end of course (T1, approximately 14 weeks)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Results publicationBagby 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.
- Course SyllabusLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data (IPD) underlying the results reported in publications (e.g., TAS-20 total/subscale scores and scenario-based empathy scores at T0 and T1) will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the primary results, for up to 5 years. Requests will be reviewed by the study team and may require a data use agreement. Shared datasets will be de-identified and will not include direct identifiers; access will be limited to the minimum necessary to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mustafa Onur Yurdal, PhD study chair
Çanakkale Onsekiz Mart University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Film-Based Medical Education and Social Justice Elective in people with Alexithymia and Empathy Skills, run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Alexithymia Scale (TAS-20) Total and Subscale Scores (Change) (time frame: Baseline (T0) and end of course (T1, approximately 14 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07399366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.