NCT07500584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 19, 2026

Last Update Submit

March 29, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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.

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

  • Basic Empathy Scale (BES)

    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

    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)

Study Arms (2)

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

InterventionBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, Ümraniye, 34760, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the psychodrama intervention, blinding of participants and researchers was not feasible. However, outcome assessment and statistical analyses were conducted by an independent assessor who was blinded to group allocation. Data were coded prior to analysis to ensure that the assessor remained unaware of participants' group assignments, there by minimizing potential assessment bias.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study is designed as a randomized, parallel-group controlled trial. Participants will be randomly allocated to either the psychodrama intervention group or a no-intervention control group. The intervention consists of 10 structured psychodrama sessions delivered twice weekly. Outcome assessments will be conducted at baseline, immediately after the intervention, and at a 2-month follow-up.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Nurse

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 30, 2026

Study Start

March 20, 2024

Primary Completion

May 20, 2024

Study Completion

June 20, 2024

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations