UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062140 |
|---|---|
| Receipt number | R000071100 |
| Scientific Title | Development of an AI-Based Practicum Support Agent for Nursing Students: Feasibility Evaluation of Classroom Implementation |
| Date of disclosure of the study information | 2026/07/06 |
| Last modified on | 2026/07/05 09:10:32 |
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Basic information
Public title
Development of an AI-Based Practicum Support Agent for Nursing Students: Feasibility Evaluation of Classroom Implementation
Acronym
Classroom Feasibility NAIS Trial (Nursing-AI Support)
Scientific Title
Development of an AI-Based Practicum Support Agent for Nursing Students: Feasibility Evaluation of Classroom Implementation
Scientific Title:Acronym
Classroom Feasibility NAIS Trial (Nursing-AI Support)
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of implementing, in classroom settings, an AI agent based on generative artificial intelligence (AI) that provides autonomous guidance to support nursing students in resolving challenges and questions encountered during clinical practicums.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in self-efficacy for clinical practicum documentation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A web-based application utilizing generative AI was provided to deliver autonomous guidance to nursing students regarding questions and challenges encountered during clinical practice.
Interventions/Control_2
No-intervention group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
* Undergraduate nursing students enrolled at a nursing university.
* Students scheduled to take a course in the subject area for which the AI model was developed.
* Students who understood the purpose and procedures of the study and provided written informed consent.
Key exclusion criteria
* Individuals unable to use the required device (e.g., a personal computer or tablet).
* Individuals judged to be unable to provide continuous study data because of poor health or other reasons.
* Individuals who withdrew their consent to participate in the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Asahiko |
| Middle name | |
| Last name | Higashitusji |
Organization
Chiba prefectural university of health sciences
Division name
Faculty of Healthcare Sciences
Zip code
2610014
Address
2-10-1 Wakaba, Mihama-ku, Chiba City
TEL
0432722000
cpuhs1@mz.pref.chiba.lg.jp
Public contact
Name of contact person
| 1st name | Asahiko |
| Middle name | |
| Last name | Higashitsuji |
Organization
Chiba prefectural university of health sciences
Division name
Faculty of Healthcare Sciences
Zip code
2610014
Address
2-10-1 Wakaba, Mihama-ku, Chiba City
TEL
0432722000
Homepage URL
cpuhs1@mz.pref.chiba.lg.jp
Sponsor or person
Institute
Chiba prefectural university of health sciences
Institute
Department
Personal name
Funding Source
Organization
Chiba prefectural university of health sciences
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Chiba Prefectural University of Health Sciences
Address
2-10-1 Wakaba, Mihama-ku, Chiba City
Tel
0432722000
cpuhs1@mz.pref.chiba.lg.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 05 | Day |
Last modified on
| 2026 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071100
