Educational ActivitiesNCT05547893
Clinical Learning Through Extended Immersion in Medical Simulation (CLEIMS)-A New Approach to Teaching Clinical Ethics
A study testing simulation in people with Educational Activities and Patient Simulation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Study objective: This study is planning to develop a new simulation-based ethics education model and evaluate the effectiveness of the model to develop medical students' knowledge, moral reasoning, communication skills, and problem-solving abilities. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Activities, Patient Simulation
- What is being tested?
- simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Sep 2020to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- medical students in Kaohsiung Medical University
- agree to participate the study
Who cannot join
- disagree to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
Yenko Lin, +886-7-3121101 ext. 7579, yenko@ms16.hinet.net
About this study
Study objective: This study is planning to develop a new simulation-based ethics education model and evaluate the effectiveness of the model to develop medical students' knowledge, moral reasoning, communication skills, and problem-solving abilities. Several strategies will be conducted to achieve this goal, including faculty development, ethics courses development, and case scenario development.
Methods: The transnational learning and workshops will be arranged for faculty to develop competence for simulation-based ethics education. The workshops will gather the interdisciplinary experts together to discuss and develop the core curriculum and case scenario. The students will be assigned randomly into the simulated clinical ethical situation with simulation patients for the intervention group, and into the workshop discussing clinical ethics case scenario for the control group. The instruments will be developed and the quantitative and qualitative analysis will be conducted.
- Conditions
- Educational Activities, Patient Simulation
- Being tested
- simulation
- Keywords
- medical ethics education, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulationOther
participating a simulated clinical ethical situation with simulation patients
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | workshop discussing the clinical ethical case scenario |
| Intervention group | Experimental | a simulated clinical ethical situation with simulation patients Receives: Other: simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defining Issues Test (DIT) and self-developed questionnaire
Defining Issues Test (DIT) and self-developed questionnaire for evaluation of moral reasoning
Measured: through study completion, an average of 2 years
ethical decision-making clinical examination
clinical scenario exam designed for testing participants' ability of making ethical decision
Measured: through study completion, an average of 2 years
Problem Identification Test (PIT) and self-developed questionnaire
Problem Identification Test (PIT) and self-developed questionnaire for evaluation of moral sensitivity
Measured: through study completion, an average of 2 years
knowledge test questionnaire
questionnaire for ethics knowledge test
Measured: through study completion, an average of 2 years
Secondary outcomes (2)
results of Objective Structured Clinical Examination
test score of Objective Structured Clinical Examination
Measured: through study completion, an average of 2 years
participant satisfaction questionnaire
satisfaction questionnaire for participating the educational activities
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start29 Sep 2020
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Educational ActivitiesStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547893
- Sponsor's protocol ID
- KMUHIRB-SV(II)-20200041
- Status last verified
- Feb 2026
- First submitted
- 4 Sep 2022
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin YK, Liu HL, Chang PC, Lin CJ, Chen CW, Yeh YS. Sequential simulation-based clinical ethics education for clerkship students: A mixed-methods pre-post study. Med Teach. 2026 Aug 5:1-17. doi: 10.1080/0142159X.2026.2708308. Online ahead of print.
PubMed 42554598
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Learning Through Extended Immersion in Medical Simulation (CLEIMS)-A New Approach to Teaching Clinical Ethics
- ClinicalTrials.gov ID
- NCT05547893
- Acronym / sponsor ID
- KMUHIRB-SV(II)-20200041
- Conditions
- Educational Activities, Patient Simulation
- Keywords
- medical ethics education, simulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 21 Sep 2022 (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.
Study objective: This study is planning to develop a new simulation-based ethics education model and evaluate the effectiveness of the model to develop medical students' knowledge, moral reasoning, communication skills, and problem-solving abilities. Several strategies will be conducted to achieve this goal, including faculty development, ethics courses development, and case scenario development.
Methods: The transnational learning and workshops will be arranged for faculty to develop competence for simulation-based ethics education. The workshops will gather the interdisciplinary experts together to discuss and develop the core curriculum and case scenario. The students will be assigned randomly into the simulated clinical ethical situation with simulation patients for the intervention group, and into the workshop discussing clinical ethics case scenario for the control group. The instruments will be developed and the quantitative and qualitative analysis will be conducted.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –workshop discussing the clinical ethical case scenario |
| Intervention group | Experimental | Other: simulationa simulated clinical ethical situation with simulation patients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- medical students in Kaohsiung Medical University
- agree to participate the study
Key exclusion criteria (1 listed)
- disagree to participate
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 |
|---|---|---|
| simulationparticipating a simulated clinical ethical situation with simulation patients | Other | Intervention group |
Primary outcome
Defining Issues Test (DIT) and self-developed questionnaire
Time frame: through study completion, an average of 2 years
Defining Issues Test (DIT) and self-developed questionnaire for evaluation of moral reasoning
ethical decision-making clinical examination
Time frame: through study completion, an average of 2 years
clinical scenario exam designed for testing participants' ability of making ethical decision
Problem Identification Test (PIT) and self-developed questionnaire
Time frame: through study completion, an average of 2 years
Problem Identification Test (PIT) and self-developed questionnaire for evaluation of moral sensitivity
knowledge test questionnaire
Time frame: through study completion, an average of 2 years
questionnaire for ethics knowledge test
2 secondary outcomes
results of Objective Structured Clinical Examination
Time frame: through study completion, an average of 2 years
participant satisfaction questionnaire
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Derived from this study: PubMed 42554598Lin YK, Liu HL, Chang PC, Lin CJ, Chen CW, Yeh YS. Sequential simulation-based clinical ethics education for clerkship students: A mixed-methods pre-post study. Med Teach. 2026 Aug 5:1-17. doi: 10.1080/0142159X.2026.2708308. Online ahead of print.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulation in people with Educational Activities and Patient Simulation, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 Feb 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yenko Lin (+886-7-3121101 ext. 7579, yenko@ms16.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defining Issues Test (DIT) and self-developed questionnaire (time frame: through study completion, an average of 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05547893, which also lists 1 linked publication.
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 11 Feb 2026.