UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058430 |
|---|---|
| Receipt number | R000066810 |
| Scientific Title | A Study of the Impact of a Virtual Communication App Replicating Psychiatric Symptoms with AI on Nursing Students: A Feasibility Study |
| Date of disclosure of the study information | 2025/07/11 |
| Last modified on | 2025/07/11 12:26:04 |
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Basic information
Public title
A Study of the Impact of a Virtual Communication App Replicating Psychiatric Symptoms with AI on Nursing Students: A Feasibility Study
Acronym
A Study of the Impact of a Virtual Communication App Replicating Psychiatric Symptoms with AI on Nursing Students: A Feasibility Study
Scientific Title
A Study of the Impact of a Virtual Communication App Replicating Psychiatric Symptoms with AI on Nursing Students: A Feasibility Study
Scientific Title:Acronym
A Study of the Impact of a Virtual Communication App Replicating Psychiatric Symptoms with AI on Nursing Students: A Feasibility Study
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to confirm the psychological safety (anxiety level) of students by using a virtual communication application that reproduces psychiatric symptoms with AI, as well as the feasibility of a large-scale intervention study (RCT) by conducting a small-scale pre/post comparison study to examine the impact on self-efficacy for clinical practice. The purpose of this study is to confirm the feasibility of a large-scale intervention study (RCT) and to identify modifications (e.g., study design, intervention subject criteria and sample size, evaluation measures, timing of intervention, etc.).
Basic objectives2
Others
Basic objectives -Others
For the intervention group, impressions (subjective experience) of using a virtual communication application that reproduces psychiatric symptoms with AI will be collected through focus group interviews.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
<Safety endpoints>
-Adverse events (interruption of study due to complaints of mood discomfort, etc.)
-STAI Japanese version (for university students) (Shimizu and Imae,1981)
<Efficacy endpoints>
-Trait self-efficacy scale (Sherer et al.,1982; Narita et al.,1995)
-Self-efficacy of nursing students in clinical practice from preliminary scale [Communication skills] (Manabe et al., 2007)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
This is a 90-minute class similar to the "Therapeutic Communication" class offered in the second semester of the third year (around October). The target students are those who have not yet taken this class.
Communication exercise using a virtual communication application that reproduces mental symptoms by AI.
A communication exercise using a virtual communication application that reproduces mental symptoms by AI will be given for about 60 minutes. Two examples are set as the state of the communication partner: "a person with schizophrenia and active positive symptoms" and "a person with depression and strong feelings of hopelessness". Assuming that the patient is in inpatient treatment, this is the first visit to the room during that workday, and the student begins with a greeting to take charge of the patient's condition for the day. Although no communication goal is set, the flow of communication is developed by considering appropriate communication in response to the patient's complaints of distress.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Third-year students belonging to the Department of Nursing, Hamamatsu University School of Medicine
Key exclusion criteria
Third-year transfer students (because they have already completed their clinical training and hold a nursing license)
Target sample size
6
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 Clinical Nursing, School of Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2823
ykido@hama-med.ac.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 Clinical Nursing, School of Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
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
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
Tel
053-435-2680
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 | 07 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | 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 | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066810
