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Completed

NCT Number: NCT07500584

The Impact of Psychodrama Intervention on the Empathy, Self-compassion and Psychological Well-Being of University Students

This study is a randomized controlled trial designed to evaluate the effectiveness of a structured psychodrama-based intervention on psychological well-being, empathy, self-compassion, and personality-related characteristics among undergraduate nursing students.

The study will be conducted at the Faculty of Nursing, University of Foggia, Italy, with students enrolled in the Department of Medical and Surgical Sciences. Participants will be randomly assigned to either an intervention group or a control group using a computer-generated randomization procedure.

The intervention group will participate in a structured psychodrama program consisting of ten weekly sessions, each lasting approximately two hours. The sessions will be conducted by a certified psychodrama therapist, following a structured framework aimed at enhancing emotional awareness, interpersonal skills, role-taking capacity, and psychological well-being. The control group will not receive any intervention during the study period and will continue with their routine academic activities.

Data will be collected at three time points: baseline (pre-test), post-intervention, and a 2-month follow-up. In the pre-, post-, and follow-up assessments, the Positive and Negative Affect Schedule (PANAS), PERMA Profiler, Basic Empathy Scale (BES), Self-Compassion Scale (SCS), Emotional Contagion Scale (ECS), Rosenberg Self-Esteem Scale, and the HEXACO Personality Inventory will be administered.

The primary aim of the study is to determine whether psychodrama intervention leads to significant improvements in psychological well-being and interpersonal functioning compared to the control group. Secondary outcomes include changes in empathy, self-compassion, emotional contagion, self-esteem, affective states, and personality traits.

This study adopts a mixed factorial design (intervention vs. control × time), allowing for the evaluation of both short-term and sustained effects of the intervention. The findings are expected to contribute to the development of evidence-based educational and psychosocial interventions aimed at supporting the mental health and professional development of nursing students.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erenköy Mental and Nervous Diseases Training and Research Hospital, University of Health Sciences, Istanbul, Turkey

Istanbul, Ümraniye, 34760, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being an undergraduate nursing student enrolled in the Department of Medical and Surgical Sciences.
  • Providing voluntary informed consent after being informed about the aims and procedures of the study.
  • Signing the group contract

Exclusion criteria

  • Personally knowing the group leader or co-leader.
  • Reporting inability to participate in all assessment phases (T1: Pre-test, T2:

Post-test, T3: Follow-up test).

  • Self-reporting the use of psychiatric medication or currently receiving clinical psychiatric treatment.
  • Indicating that the scheduled session days and times are not suitable (these participants are assigned to the control group after providing informed consent).

Treatment and study plan

Intervention

Behavioral

The intervention consisted of a structured, manualized psychodrama program delivered in a group format. The program included 10 weekly sessions, each lasting approximately 120-150 minutes. Sessions were facilitated by a certified psychodramatist under the supervision of an accredited psychodrama trainer. The intervention incorporated core psychodrama techniques such as role-playing, role reversal, mirroring, doubling, and enactment to enhance emotional expression, empathy, and self-awareness. The program followed a standardized session structure including warm-up, action, and sharing phases, ensuring consistency across sessions.

Primary outcomes

  1. Emotional Contagion Scale (ECS)

    Time frame: pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)

    The Emotional Contagion Scale (ECS) measures the extent to which individuals are susceptible to others' emotions. It assesses emotional responsiveness and the tendency to "catch" others' emotional states.

  2. Positive and Negative Affect Schedule (PANAS)

    Time frame: pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)

    The Positive and Negative Affect Schedule (PANAS) is used to assess individuals' levels of positive (e.g., enthusiasm, alertness) and negative (e.g., distress, irritability) affect. It provides a measure of emotional well-being and allows for the evaluation of changes in affective states over time.

  3. Self-Compassion Scale (SCS)

    Time frame: pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)

    The Self-Compassion Scale (SCS) is used to evaluate individuals' level of self compassion. It includes components such as self-kindness, self-judgment, common humanity, and mindfulness.

  4. Rosenberg Self-Esteem Scale

    Time frame: pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)

    The Rosenberg Self-Esteem Scale is employed to measure global self-esteem. It assesses individuals' overall evaluation of their self-worth, including both positive and negative self-perceptions.

  5. PERMA Profiler

    Time frame: pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)

    The PERMA Profiler is utilized to evaluate psychological well-being within the framework of positive psychology. It measures five core dimensions: Positive Emotion, Engagement, Relationships, Meaning, and Accomplishment.

  6. Basic Empathy Scale (BES)

    Time frame: pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)

    The Basic Empathy Scale (BES) is used to assess individuals' empathy levels. It evaluates both cognitive empathy (the ability to understand others' emotions) and affective empathy (the ability to share others' emotional experiences).

  7. HEXACO Personality Inventory

    Time frame: pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)

    The HEXACO Personality Inventory is used to assess personality traits based on a six-factor model: Honesty-Humility, Emotionality, Extraversion, Agreeableness, Conscientiousness, and Openness to Experience.

Sponsors and collaborators

Lead sponsor

Ministry of Health, Turkey

Other Gov

Registry information

Official study title

The Impact of Psychodrama Intervention on the Empathy, Self-Compassion and Psychological Well-Being of University Students: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 30, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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