UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059214 |
|---|---|
| Receipt number | R000067726 |
| Scientific Title | The Effect of Communication App Exercises Using AI-Simulated Individuals with Psychiatric Symptoms on Students' Anxiety and Confidence: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/09/29 |
| Last modified on | 2025/09/27 11:21:08 |
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Basic information
Public title
The effect of AI exercises on student anxiety and confidence
Acronym
Effect of AI Exercises
Scientific Title
The Effect of Communication App Exercises Using AI-Simulated Individuals with Psychiatric Symptoms on Students' Anxiety and Confidence: A Randomized Controlled Trial
Scientific Title:Acronym
Effect of AI Exercises
Region
| Japan |
Condition
Condition
Nursing students interacting with individuals with mental disorders
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this randomized controlled trial is to demonstrate that nursing students' anxiety about communicating with individuals exhibiting psychiatric symptoms decreases and their self-efficacy increases when they practice using a communication app that employs AI to simulate such individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
New Edition STAI: The intervention group is expected to show a significant reduction in anxiety levels compared to the control group.
Key secondary outcomes
Self-Efficacy Scale: The intervention group is expected to show a significant increase in self-efficacy compared to the control group.
Communication Skills from the Nursing Students' Clinical Practice Self-Efficacy Preliminary Scale: The intervention group is expected to show a significant improvement in communication with individuals exhibiting psychiatric symptoms compared to the control group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Exercise Using a Communication App Simulating Individuals with Psychiatric Symptoms via AI
Participants first attend a lecture on therapeutic communication in psychiatric nursing, then conduct communication exercises using an app that simulates individuals with psychiatric symptoms via AI. One scenario depicts a person with schizophrenia experiencing active positive symptoms. The scenario assumes the patient is undergoing inpatient treatment. Students begin by greeting the patient as their assigned caregiver for the day and then assess the patient's current condition. While no specific communication goal is set, the flow involves developing communication while considering appropriate responses to the patient's expressed concerns. Participants work in groups of three, taking turns using one device. The other two members observe, and the exercise is repeated while exchanging feedback.
Interventions/Control_2
Paper-based simulated patient exercises
Participants first attend a lecture on therapeutic communication in psychiatric nursing. They then engage in communication with a paper-based simulated patient (one case: a person with schizophrenia experiencing active positive symptoms) based on the same scenario as the intervention group. Participants form groups of three, taking turns playing the roles of patient, nurse, and observer in role-play scenarios. They reflect on their performance, exchange feedback, and repeat the role-play as needed.
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
1. Must be a student enrolled in the Department of Nursing at Hamamatsu University School of Medicine or the Department of Nursing at Miyazaki University School of Medicine.
2. Must have completed the foundational courses related to psychiatric nursing specified by each university's nursing department (e.g., lectures on the pathophysiology and treatment of psychiatric disorders, Introduction to Psychiatric Nursing, etc.), and must not have completed the psychiatric nursing clinical practicum. This ensures a homogeneous group in terms of knowledge and experience.
3. Be able to communicate effectively in Japanese both orally and in writing, and be able to respond appropriately to questionnaires in Japanese.
Key exclusion criteria
1.Individuals who have already completed clinical practice in psychiatric nursing, or transfer students who hold a nursing license and possess experience equivalent to clinical practice in the psychiatric field.
2.Individuals experiencing severe psychological distress to the extent that researchers judge the study intervention is likely to exacerbate it, or those who self-report such a risk.
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kido |
Organization
Hamamatsu University School of Medicine
Division name
Department of Nursing, Faculty of Medicine
Zip code
431-3192
Address
Department of Nursing, Faculty of Medicine
TEL
0534352111
ykido@hama-med.ad.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kido |
Organization
Hamamatsu University School of Medicine
Division name
Department of Nursing, Faculty of Medicine
Zip code
431-3192
Address
Department of Nursing, Faculty of Medicine
TEL
053-435-2823
Homepage URL
ykido@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu Medical University, Department of Life Sciences and Medicine, Research Ethics Committee
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
Tel
053-435-2823
rinri@hama-med.ac.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
| 2025 | Year | 09 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2025 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067726
