Healthy VolunteersNCT07760389
Impact of Simulation-Based Intervention on Empathy, Communication, and Self-Efficacy Among Mental Health Nursing Students
A study of Healthy Volunteers, run by Near East University, Turkey at 1 site in Cyprus.
Trial summary
This randomized controlled trial aims to evaluate the effectiveness of a standardized patient simulation-based educational intervention among undergraduate nursing students enrolled in the Mental Health Nursing course at the Department of Nursing, Faculty of Health Sciences, Cyprus International University, during the… Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCyprus
- Study dates
- 1 May 2026to 29 May 2026
- 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 18 to 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Were officially and early registered in the mental health nursing course
- Provided informed consent to participate
- Were available throughout the duration of the intervention
Who cannot join
- Declined to participate
- Were absent during key phases of the intervention
- Did not complete the required data collection instruments.
- Late registration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating The Impact of A Simulation-Based Intervention on Empathy, Therapeutic Communication, And Self-Efficacy Among Mental Health Nursing Students: Guided by Jean Watson Theory
This randomized controlled trial aims to evaluate the effectiveness of a standardized patient simulation-based educational intervention among undergraduate nursing students enrolled in the Mental Health Nursing course at the Department of Nursing, Faculty of Health Sciences, Cyprus International University, during the 2025-2026 academic year.
A total of 70 eligible undergraduate nursing students were randomly allocated to an experimental group or a control group. Students in the experimental group participated in a structured simulation-based educational program using trained standardized patients portraying individuals with bipolar disorder. The simulation scenarios represent common clinical presentations of bipolar disorder, including acute manic episodes, depressive episodes , emotional instability, and mixed features associated with medication non-adherence. Students practice mental health assessment, therapeutic communication, therapeutic relationship building, and appropriate nursing interventions, followed by structured debriefing and reflection.
Read more
The intervention was based on the principles of Jean Watson's Theory of Human Caring and was delivered through weekly simulation sessions. The control group received the routine Mental Health Nursing curriculum, including theoretical instruction and regular clinical placement experiences, without participation in the standardized patient simulation program.
The primary outcome is therapeutic communication skills, while secondary outcomes include empathy and communication self-efficacy. Outcomes will be assessed using validated assessment scales at baseline and after completion of the intervention. The study evaluate whether standardized patient simulation is more effective than traditional teaching methods in developing key clinical and interpersonal competencies among undergraduate nursing students preparing to care for patients with bipolar disorder.
Read the detailed description
### Detailed Description
Mental health nursing education requires students to develop not only theoretical knowledge but also the interpersonal and clinical skills needed to establish therapeutic relationships and communicate effectively with individuals experiencing mental health conditions. Traditional teaching approaches may provide limited opportunities for students to practice these skills in realistic and controlled clinical situations.
This study investigate whether standardized patient simulation can provide an effective educational approach for developing key competencies among undergraduate nursing students enrolled in a Mental Health Nursing course. The simulation-based intervention will use trained standardized patients to portray individuals with bipolar disorder in realistic clinical scenarios. The scenarios was design was taking from a textbook of mental health scenarios to reflect different clinical presentations and challenges that nursing students may encounter when caring for individuals with bipolar disorder.
The educational approach incorporated principles derived from Jean Watson's Theory of Human Caring, with particular emphasis on the development of empathy, therapeutic communication, therapeutic relationships, and students' confidence in communicating with patients. Simulation activities provide students with opportunities to apply theoretical knowledge in practice, receive structured feedback, and reflect on their clinical performance through guided debriefing.
The study used a randomized controlled design to compare the simulation-based educational approach with the routine Mental Health Nursing curriculum. The study examine whether participation in standardized patient simulation results in greater improvements in therapeutic communication, empathy, and communication self-efficacy compared with conventional educational approaches.
The findings of this study may contribute to the evidence regarding the use of standardized patient simulation in undergraduate mental health nursing education and may help inform the development of educational strategies aimed at strengthening students' clinical and interpersonal competencies before and during their clinical practice.
- Conditions
- Healthy Volunteers
- Being tested
- Experimental Group and Control Group
- Keywords
- Simulation-Based Learning in Mental Health Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Group and Control GroupBehavioural
An organized simulation-focused training initiative utilizing standardized patients and bipolar disorder case studies to enable mental health nursing students to enhance their therapeutic communication, Empathy Self efficacy and nurse-patient engagement skills. The Experimental group were provided a structure simulation training with standardize patient scenarios guided by Jean Watson's Theory of Human Caring and features systematic simulation activities, interaction with standardized patients, supported debriefing sessions. while Control group has no simulation training only traditional curriculum lecture was given.
| Study group | Role | What they receive |
|---|---|---|
| Simulation based education | Experimental | Intervention: Simulation-Based Education Using Standardized Students
Participants assigned to the experimental group received a structured simulation-based educational intervention using trained standardized patients (SPs) portraying individuals with bipolar disorder. The intervention was developed based on the principles of Jean Watson's Theory of Human Caring and will focus on developing students' therapeutic communication skills, empathy, and communication self-efficacy in mental health nursing.
The intervention will consist of two simulation sessions per week, with each session lasting approximately 75 minutes. During each session, students will be divided into five groups of seven students. Trained standardized patients portray realistic clinical scenarios representing different presentations and challenges associated with bipolar disorder, including acute manic episodes, depressive episodes , emotional instability, and medication non adherence Receives: Behavioral: Experimental Group and Control Group |
| Control group | No intervention | the students participated on the regular semester lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic communication
Therapeutic communication, measured using the Therapeutic Communication Scale. The scale consists of 15 items, each rated on a 0-5 Likert-type scale. All items are scored in the same direction, with no reverse-scored items. Total scores range from 15 to 75, with higher scores indicating greater competence in therapeutic communication.
Measured: Baseline and week 4 (end of intervention)
Secondary outcomes (2)
Empathy
Empathy, measured using the Empathy Assessment Scale. The scale consists of 13 items, each rated on a 1-5 Likert scale. All items are scored in the same direction, with no reverse-scored items. Total scores range from 13 to 65, with higher scores indicating greater empathy.
Measured: Baseline and week 4 (end of intervention)
Self Efficacy
Self-efficacy, measured using the Self-Efficacy in Communication Scale (KSE-12). The scale consists of 12 items, each rated on a 1-5 Likert scale. All items are scored in the same direction, with no reverse-scored items. Total scores range from 12 to 60, with higher scores indicating greater communication self-efficacy.
Measured: Baseline and week 4 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 May 2026
- Primary completion22 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The simulation teaching is given to the students' participant group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joy Johnson Agbo, Near East University, Turkey
- Investigators
- JOY J. AGBO, PhD Student, Principal investigator, Near East University, Nursing Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760389
- Sponsor's protocol ID
- NearEastU
- Other IDs
- Joy Johnson Agbo
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Impact of A Simulation-Based Intervention on Empathy, Therapeutic Communication, And Self-Efficacy Among Mental Health Nursing Students: Guided by Jean Watson Theory
- ClinicalTrials.gov ID
- NCT07760389
- Acronym / sponsor ID
- NearEastU
- Conditions
- Healthy Volunteers
- Keywords
- Simulation-Based Learning in Mental Health Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 12 Aug 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 randomized controlled trial aims to evaluate the effectiveness of a standardized patient simulation-based educational intervention among undergraduate nursing students enrolled in the Mental Health Nursing course at the Department of Nursing, Faculty of Health Sciences, Cyprus International University, during the 2025-2026 academic year.
A total of 70 eligible undergraduate nursing students were randomly allocated to an experimental group or a control group. Students in the experimental group participated in a structured simulation-based educational program using trained standardized patients portraying individuals with bipolar disorder. The simulation scenarios represent common clinical presentations of bipolar disorder, including acute manic episodes, depressive episodes , emotional instability, and mixed features associated with medication non-adherence. Students practice mental health assessment, therapeutic communication, therapeutic relationship building, and appropriate nursing interventions, followed by structured debriefing and reflection.
The intervention was based on the principles of Jean Watson's Theory of Human Caring and was delivered through weekly simulation sessions. The control group received the routine Mental Health Nursing curriculum, including theoretical instruction and regular clinical placement experiences, without participation in the standardized patient simulation program.
The primary outcome is therapeutic communication skills, while secondary outcomes include empathy and communication self-efficacy. Outcomes will be assessed using validated assessment scales at baseline and after completion of the intervention. The study evaluate whether standardized patient simulation is more effective than traditional teaching methods in developing key clinical and interpersonal competencies among undergraduate nursing students preparing to care for patients with bipolar disorder.
Detailed description
### Detailed Description
Mental health nursing education requires students to develop not only theoretical knowledge but also the interpersonal and clinical skills needed to establish therapeutic relationships and communicate effectively with individuals experiencing mental health conditions. Traditional teaching approaches may provide limited opportunities for students to practice these skills in realistic and controlled clinical situations.
This study investigate whether standardized patient simulation can provide an effective educational approach for developing key competencies among undergraduate nursing students enrolled in a Mental Health Nursing course. The simulation-based intervention will use trained standardized patients to portray individuals with bipolar disorder in realistic clinical scenarios. The scenarios was design was taking from a textbook of mental health scenarios to reflect different clinical presentations and challenges that nursing students may encounter when caring for individuals with bipolar disorder.
The educational approach incorporated principles derived from Jean Watson's Theory of Human Caring, with particular emphasis on the development of empathy, therapeutic communication, therapeutic relationships, and students' confidence in communicating with patients. Simulation activities provide students with opportunities to apply theoretical knowledge in practice, receive structured feedback, and reflect on their clinical performance through guided debriefing.
The study used a randomized controlled design to compare the simulation-based educational approach with the routine Mental Health Nursing curriculum. The study examine whether participation in standardized patient simulation results in greater improvements in therapeutic communication, empathy, and communication self-efficacy compared with conventional educational approaches.
The findings of this study may contribute to the evidence regarding the use of standardized patient simulation in undergraduate mental health nursing education and may help inform the development of educational strategies aimed at strengthening students' clinical and interpersonal competencies before and during their clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The simulation teaching is given to the students' participant group
| Arm | Type | Receives |
|---|---|---|
| Simulation based education | Experimental | Behavioral: Experimental Group and Control GroupIntervention: Simulation-Based Education Using Standardized Students Participants assigned to the experimental group received a structured simulation-based educational intervention using trained standardized patients (SPs) portraying individuals with bipolar disorder. The intervention was developed based on the principles of Jean Watson's Theory of Human Caring and will focus on developing students' therapeutic communication skills, empathy, and communication self-efficacy in mental health nursing. The intervention will consist of two simulation sessions per week, with each session lasting approximately 75 minutes. During each session, students will be divided into five groups of seven students. Trained standardized patients portray realistic clinical scenarios representing different presentations and challenges associated with bipolar disorder, including acute manic episodes, depressive episodes , emotional instability, and medication non adherence |
| Control group | No intervention | –the students participated on the regular semester lecture |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Were officially and early registered in the mental health nursing course
- Provided informed consent to participate
- Were available throughout the duration of the intervention
Key exclusion criteria (4 listed)
- Declined to participate
- Were absent during key phases of the intervention
- Did not complete the required data collection instruments.
- Late registration
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 |
|---|---|---|
| Experimental Group and Control GroupAn organized simulation-focused training initiative utilizing standardized patients and bipolar disorder case studies to enable mental health nursing students to enhance their therapeutic communication, Empathy Self efficacy and nurse-patient engagement skills. The Experimental group were provided a structure simulation training with standardize patient scenarios guided by Jean Watson's Theory of Human Caring and features systematic simulation activities, interaction with standardized patients, supported debriefing sessions. while Control group has no simulation training only traditional curriculum lecture was given. | Behavioural | Simulation based education |
Primary outcome
Therapeutic communication
Time frame: Baseline and week 4 (end of intervention)
Therapeutic communication, measured using the Therapeutic Communication Scale. The scale consists of 15 items, each rated on a 0-5 Likert-type scale. All items are scored in the same direction, with no reverse-scored items. Total scores range from 15 to 75, with higher scores indicating greater competence in therapeutic communication.
2 secondary outcomes
Empathy
Time frame: Baseline and week 4 (end of intervention)
Self Efficacy
Time frame: Baseline and week 4 (end of intervention)
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 18 Aug 2026.
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Irritability
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.
JOY J. AGBO, PhD Student principal investigator
Near East University, Nursing Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy Volunteers, run by Near East University, Turkey at 1 site in Cyprus.
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 4 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 18 Aug 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 Cyprus. 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?
Therapeutic communication (time frame: Baseline and week 4 (end of intervention)). 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 18 Aug 2026.