The Impact of Psychodrama Intervention on the Empathy, Se... | NCT07500584

Status Module

Oversight Module

Description Module

Brief Summary

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	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.	Behavioral: Intervention
Control group	No Intervention	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Emotional Contagion Scale (ECS)	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)	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)	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	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	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.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Erenköy Mental and Nervous Diseases Training and Research Hospital, University of Health Sciences, Istanbul, Turkey		Istanbul	Ümraniye	34760	Turkey (Türkiye)

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