Undergraduate Nursing StudentsNCT07811245
Effect of GenAI Patient Simulation on Clinical Preparedness and Clinical Competence in Nursing Students
A study testing GenAI Patient Simulation Platform in people with Undergraduate Nursing Students, run by The University of Hong Kong.
Trial summary
The transition from theoretical knowledge to clinical practice is a critical and challenging phase for nursing students. Limited opportunities for scenario-based learning before an clinical practicum impacts students' preparedness for practice and clinical competence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Undergraduate Nursing Students
- What is being tested?
- GenAI Patient Simulation Platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2026to 31 Mar 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Year 3 nursing students of a 5-year full-time Bachelor in Nursing programme,
- of any nationality including non-local and non-Chinese students, and
- able to read and understand English, and
- completed the introduction of clinical nursing practicum in year 2, and
- scheduled to undertake their first acute clinical practicum within the same academic year.
Who cannot join
- Year 3 nursing students of a 5-year full-time Bachelor in Nursing programme, who will not have their first acute clinical practicum within that academic year.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Generative Artificial Intelligence (GenAI) Patient Simulation on Preparedness for Clinical Practicum and Clinical Competence Among Undergraduate Nursing Students: A Waitlist Randomized Controlled Trial and Mixed-methods Study
The transition from theoretical knowledge to clinical practice is a critical and challenging phase for nursing students. Limited opportunities for scenario-based learning before an clinical practicum impacts students' preparedness for practice and clinical competence. Consequently, this lack of preparation directly fuels stress, creating a a negative feedback loop where this stress inhibits cognitive processing and effective learning. Generative artificial intelligence (GenAI) has emerged as a novel educational technology capable of providing interactive, flexible, and learner-centred simulation experiences.
This waitlist randomised controlled trial aims to examine the effectiveness of incorporating the GenAI patient simulation in preparing the undergraduate nursing students for clinical practicum and enhancing the clinical competence compared to the current practice. Hypotheses of this study include:
- Participants using the GenAI patient simulation will report higher preparedness for the first acute clinical practicum (CP) and higher clinical competence scores compared to the usual practice group at all time points.
- The frequency of using the GenAI patient simulation will be positively correlated with preparedness for the CP and clinical competence.
- Participants using the GenAI patient simulation will report lower perceived stress before and during the CP compared to the usual practice group.
- The frequency of using of the GenAI patient simulation will negatively correlate with the levels of perceived stress before and during the CP.
Read the detailed description
Clinical practicum represents a critical transition point in undergraduate nursing education. Although pre-practicum workshops are commonly provided, students continue to experience difficulties in applying theoretical knowledge during the clinical practicum in acute care settings. A substantial gap often exists between the workshop and the start of clinical practicum, during which opportunities for ongoing learning, reinforcement of knowledge, and practice through virtual clinical scenarios are limited. GenAI patient simulation provide additional opportunities for experiential learning, deliberate practice, and self-directed preparation before clinical exposure.
The intervention of this study is a GenAI Patient Simulation Platform.
Participants in the intervention group will receive the pre-practicum workshop as usual followed by a two-phase GenAI patient simulation intervention:
Phase 1 - a 2-hour facilitated face-to-face simulation exercise session using the scenarios in the GenAI platform.
Phase 2 - a self-initiated, wall-free GenAI patient simulation scenario package. Participants is allowed to access the platform and do the exercises before and during clinical practicum.
Participants in the waitlist control group will receive the same intervention after completion of the study.
A total of forty-four undergraduate nursing students will be recruited and randomly assigned to intervention group and waitlist control group with 1:1 allocation ratio. Participants will be fully informed about the interventions, benefits and risks of the study. Participation is entirely voluntary, and individuals may withdraw at any time without penalty.
Baseline data will be collected before randomisation (T0). All participants will complete the questionnaires immediately after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3). Participants in the intervention group will be invited to join a semi-structured interview by the end of the study.
- Conditions
- Undergraduate Nursing Students
- Being tested
- GenAI Patient Simulation Platform
- Keywords
- GenAI simulation, Readiness for clinical practicum, Clinical preparedness, Clinical competence, Perceived stress, Clinical practicum in acute settings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenAI Patient Simulation PlatformBehavioural
The intervention is a two-phase GenAI patient simulation platform.
Phase 1 - a 2-hour facilitated face-to-face simulation exercise session using the scenarios in the GenAI platform.
Phase 2 - a self-initiated, wall-free GenAI patient simulation scenario package. Participants is allowed to access the platform and do the exercises before and during clinical practicum.
GenAI Patient Simulation PlatformBehavioural
Same intervention after completion of the study.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Behavioral: GenAI Patient Simulation Platform |
| Arm 2 | Other | Waitlist control Receives: Behavioral: GenAI Patient Simulation Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preparedness for Clinical Practicum
Preparedness for clinical practicum will be measured using the Casey-Fink Readiness for Practice Survey, consists of 15 items in three domains: clinical problem solving (6 items), learning activities (5 items), and practice readiness (4 items).
The minimum and maximum mean scores for each subscale are 1 and 4, respectively. A higher mean score indicates a higher level of agreement with each subscale.
Measured: Baseline (T0), immediate after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3)
Clinical Competence
Measured by the Clinical Competency Questionnaire, consists of 47 items divided into four domains: nursing professional behaviour, general performance, core nursing skills and advanced nursing skills.
Total scores range from 47 to 235, with a higher score indicating a higher level of competence.
Measured: Baseline (T0), immediate after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3)
Secondary outcomes (1)
Perceived Stress
Measured by the Perceived Stress Scale-10.
Total scores range from 0 to 40. The higher total scores indicate higher perceived stress level.
Measured: Baseline (T0), immediate after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start28 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undergraduate Nursing StudentsStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LAM Choi Fung Mabel, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811245
- Sponsor's protocol ID
- EA260547
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Generative Artificial Intelligence (GenAI) Patient Simulation on Preparedness for Clinical Practicum and Clinical Competence Among Undergraduate Nursing Students: A Waitlist Randomized Controlled Trial and Mixed-methods Study
- ClinicalTrials.gov ID
- NCT07811245
- Acronym / sponsor ID
- EA260547
- Conditions
- Undergraduate Nursing Students
- Keywords
- GenAI simulation, Readiness for clinical practicum, Clinical preparedness, Clinical competence, Perceived stress, Clinical practicum in acute settings
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 10 Sep 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.
The transition from theoretical knowledge to clinical practice is a critical and challenging phase for nursing students. Limited opportunities for scenario-based learning before an clinical practicum impacts students' preparedness for practice and clinical competence. Consequently, this lack of preparation directly fuels stress, creating a a negative feedback loop where this stress inhibits cognitive processing and effective learning. Generative artificial intelligence (GenAI) has emerged as a novel educational technology capable of providing interactive, flexible, and learner-centred simulation experiences.
This waitlist randomised controlled trial aims to examine the effectiveness of incorporating the GenAI patient simulation in preparing the undergraduate nursing students for clinical practicum and enhancing the clinical competence compared to the current practice. Hypotheses of this study include:
- Participants using the GenAI patient simulation will report higher preparedness for the first acute clinical practicum (CP) and higher clinical competence scores compared to the usual practice group at all time points.
- The frequency of using the GenAI patient simulation will be positively correlated with preparedness for the CP and clinical competence.
- Participants using the GenAI patient simulation will report lower perceived stress before and during the CP compared to the usual practice group.
- The frequency of using of the GenAI patient simulation will negatively correlate with the levels of perceived stress before and during the CP.
Detailed description
Clinical practicum represents a critical transition point in undergraduate nursing education. Although pre-practicum workshops are commonly provided, students continue to experience difficulties in applying theoretical knowledge during the clinical practicum in acute care settings. A substantial gap often exists between the workshop and the start of clinical practicum, during which opportunities for ongoing learning, reinforcement of knowledge, and practice through virtual clinical scenarios are limited. GenAI patient simulation provide additional opportunities for experiential learning, deliberate practice, and self-directed preparation before clinical exposure.
The intervention of this study is a GenAI Patient Simulation Platform.
Participants in the intervention group will receive the pre-practicum workshop as usual followed by a two-phase GenAI patient simulation intervention:
Phase 1 - a 2-hour facilitated face-to-face simulation exercise session using the scenarios in the GenAI platform.
Phase 2 - a self-initiated, wall-free GenAI patient simulation scenario package. Participants is allowed to access the platform and do the exercises before and during clinical practicum.
Participants in the waitlist control group will receive the same intervention after completion of the study.
A total of forty-four undergraduate nursing students will be recruited and randomly assigned to intervention group and waitlist control group with 1:1 allocation ratio. Participants will be fully informed about the interventions, benefits and risks of the study. Participation is entirely voluntary, and individuals may withdraw at any time without penalty.
Baseline data will be collected before randomisation (T0). All participants will complete the questionnaires immediately after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3). Participants in the intervention group will be invited to join a semi-structured interview by the end of the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: GenAI Patient Simulation Platform |
| Arm 2 | Other | Behavioral: GenAI Patient Simulation PlatformWaitlist control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Year 3 nursing students of a 5-year full-time Bachelor in Nursing programme,
- of any nationality including non-local and non-Chinese students, and
- able to read and understand English, and
- completed the introduction of clinical nursing practicum in year 2, and
- scheduled to undertake their first acute clinical practicum within the same academic year.
Key exclusion criteria (1 listed)
- Year 3 nursing students of a 5-year full-time Bachelor in Nursing programme, who will not have their first acute clinical practicum within that academic year.
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 |
|---|---|---|
| GenAI Patient Simulation PlatformThe intervention is a two-phase GenAI patient simulation platform. Phase 1 - a 2-hour facilitated face-to-face simulation exercise session using the scenarios in the GenAI platform. Phase 2 - a self-initiated, wall-free GenAI patient simulation scenario package. Participants is allowed to access the platform and do the exercises before and during clinical practicum. | Behavioural | Arm 1 |
| GenAI Patient Simulation PlatformSame intervention after completion of the study. | Behavioural | Arm 2 |
Primary outcome
Preparedness for Clinical Practicum
Time frame: Baseline (T0), immediate after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3)
Preparedness for clinical practicum will be measured using the Casey-Fink Readiness for Practice Survey, consists of 15 items in three domains: clinical problem solving (6 items), learning activities (5 items), and practice readiness (4 items). The minimum and maximum mean scores for each subscale are 1 and 4, respectively. A higher mean score indicates a higher level of agreement with each subscale.
Clinical Competence
Time frame: Baseline (T0), immediate after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3)
Measured by the Clinical Competency Questionnaire, consists of 47 items divided into four domains: nursing professional behaviour, general performance, core nursing skills and advanced nursing skills. Total scores range from 47 to 235, with a higher score indicating a higher level of competence.
1 secondary outcome
Perceived Stress
Time frame: Baseline (T0), immediate after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3)
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 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing GenAI Patient Simulation Platform in people with Undergraduate Nursing Students, run by The University of Hong Kong.
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 5 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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Choi Fung Mabel LAM (39176694, lamcfm@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preparedness for Clinical Practicum (time frame: Baseline (T0), immediate after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3)). The study lists 2 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 21 Sep 2026.