Nursing StudentsNCT07500584
The Impact of Psychodrama Intervention on the Empathy, Self-compassion and Psychological Well-Being of University Students
A study testing Intervention in people with Nursing Students and Therapy, run by Ministry of Health, Turkey at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nursing Students, Therapy, Nursing Education
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2024to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erenköy Mental and Nervous Diseases Training and Research Hospital, University of Health Sciences, Istanbul, Turkey
Istanbul, Ümraniye, 34760
About this study
Official title: 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.
Read more
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.
- Conditions
- Nursing Students, Therapy, Nursing Education, Self Esteem, Well Being, Empathy
- Being tested
- Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: pre-test, post-test (10 weeks after pre-test-immediately after the intervention), and after 2 months (follow-up test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start20 Mar 2024
- Primary completion20 May 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing StudentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Turkey
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Müzeyyen Beste Sermet, Ministry of Health, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500584
- Sponsor's protocol ID
- code number 017/CEpsi2024
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Psychodrama Intervention on the Empathy, Self-Compassion and Psychological Well-Being of University Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07500584
- Acronym / sponsor ID
- code number 017/CEpsi2024
- Conditions
- Nursing Students, Therapy, Nursing Education, Self Esteem, Well Being, Empathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ministry of Health, TurkeyOther government
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: InterventionThe 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThe 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. | Behavioural | Intervention group |
Primary outcome
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.
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.
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.
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.
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Nursing Students
Not yet recruiting
The Effectiveness of Comic-based Learning Materials on Nursing Students' Knowledge, Attitudes, and Confidence in Dementia Care
Dementia Care Education, Students, Nursing
Not yet recruitingObservational study
AI-Based Model for Predicting Type 2 Diabetes Risk Using Lifestyle Factors Among Senior Nursing Students
Type 2 Diabetes Mellitus
Not yet recruiting
SELF-ASSESSMENT AND KNOWLEDGE LEVEL OF NURSING STUDENTS' PATIENT SAFETY COMPETENCY
Simulation Training, Nursing Education
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
The Effect of Happiness Workshops on Nursing Students' Levels of Psychological Resilience
Psychological Resilience, Nursing Students
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Nursing Students and Therapy, run by Ministry of Health, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.