- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07500584
The Impact of Psychodrama Intervention on the Empathy, Self-compassion and Psychological Well-Being of University Students
The Impact of Psychodrama Intervention on the Empathy, Self-Compassion and Psychological Well-Being of University Students: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ümraniye
-
Istanbul, Ümraniye, Turkey (Türkiye), 34760
- Erenköy Mental and Nervous Diseases Training and Research Hospital, University of Health Sciences, Istanbul, Turkey
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
The experimental group comprises 20 students who attend 10 weekly psychodrama sessions, each lasting approximately 120-150 minutes.
The sessions are conducted by a certified psychodramatist under the supervision of an accredited trainer.
Outcome measures are administered at baseline (pre-test), immediately post-intervention, and at 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), Rosenberg Self-Esteem Scale, Self- Compassion Scale (SCS), Emotional Contagion Scale (ECS), and the HEXACO Personality Inventory are used.
|
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.
|
|
No Intervention: Control group
The control group comprises 20 students and does not receive any intervention during the study period.
Outcome measures are administered at the same time points as in the experimental group, including baseline (pre-test), post-test, 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), Rosenberg Self-Esteem Scale, Self-Compassion Scale (SCS), Emotional Contagion Scale (ECS), and the HEXACO Personality Inventory are used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)
|
|
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.
|
pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)
|
|
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.
|
pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)
|
|
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.
|
pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)
|
|
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.
|
pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)
|
|
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).
|
pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)
|
|
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.
|
pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- code number 017/CEpsi2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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