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临床试验/NCT07399366
NCT07399366Enrolling By Invitation不适用

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

Çanakkale Onsekiz Mart University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
60
试验地点
1
主要终点
Toronto Alexithymia Scale (TAS-20) Total and Subscale Scores (Change)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes Assessor: Scenario-based empathy responses are scored by independent raters who are blinded to group assignment (elective vs control) and time point (T0 vs T1). Responses are de-identified and labeled with coded participant IDs prior to scoring. Unblinding occurs only after scoring is completed.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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).

研究组 & 干预措施

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.

干预措施: Film-Based Medical Education and Social Justice Elective (Behavioral)

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.

结局指标

主要结局

Toronto Alexithymia Scale (TAS-20) Total and Subscale Scores (Change)

时间窗: 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)

时间窗: 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

时间窗: 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.

次要结局

  • Association Between Change in TAS-20 and Change in Empathy Score(From baseline (T0) to end of course (T1, approximately 14 weeks))
  • Jefferson Scale of Empathy - Student Version (JSE-S) Subscale/Factor Scores (Change)(Baseline (T0) and end of course (T1, approximately 14 weeks))
  • Association Between JSE-S Score and Scenario-Based Empathy Skills Score (Convergent Validity)(Baseline (T0) and end of course (T1, approximately 14 weeks))

研究者

发起方
Çanakkale Onsekiz Mart University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Onur Yurdal

PhD, Curriculum Specialist

Çanakkale Onsekiz Mart University

研究点 (1)

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