UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059981 |
|---|---|
| Receipt number | R000068593 |
| Scientific Title | Development and Evaluation of AI-Based Educational Materials to Enhance Students' Communication Skills in Pediatric Nursing Education |
| Date of disclosure of the study information | 2025/12/10 |
| Last modified on | 2025/12/04 19:13:49 |
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Basic information
Public title
Development and Evaluation of AI-Based Educational Materials to Enhance Students' Communication Skills in Pediatric Nursing Education
Acronym
Development and Evaluation of AI-Based Educational Materials to Enhance Students' Communication Skills in Pediatric Nursing Education
Scientific Title
Development and Evaluation of AI-Based Educational Materials to Enhance Students' Communication Skills in Pediatric Nursing Education
Scientific Title:Acronym
Development and Evaluation of AI-Based Educational Materials for Enhancing Students' Communication Skills
Region
| Japan |
Condition
Condition
student
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development and Evaluation of an AI-Based Educational Tool for Enhancing Students' Communication Skills in Pediatric Nursing Education (Title: Shabereru-n)
Basic objectives2
Others
Basic objectives -Others
We believe that the development of Shabereru-n will help improve learners' communication skills and build their confidence.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mastery of pediatric nursing skills
Student satisfaction and confidence in learning and evaluation of the practice
Communication skills
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 19 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals capable of the four language skills (reading, listening, writing, speaking) in Japanese
Key exclusion criteria
Individuals incapable of performing the four language skills (reading, listening, writing, speaking) in Japanese
Target sample size
278
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Maeda |
Organization
Gifu University
Division name
School of Nursing, Faculty of Medicine
Zip code
5011194
Address
1-1, Yanagido, Gifu-shi, Gifu-ken, 501-1193, Japan
TEL
0582933250
maeda.yuki.y0@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Maeda |
Organization
Gifu University
Division name
School of Nursing, Faculty of Medicine
Zip code
5011194
Address
1-1, Yanagido, Gifu-shi, Gifu-ken, 501-1193, Japan
TEL
0582933250
Homepage URL
maeda.yuki.y0@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Yuki Maeda
Funding Source
Organization
Gifu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University
Address
1-1, Yanagido, Gifu-shi, Gifu-ken, 501-1193, Japan
Tel
0582933250
maeda.yuki.y0@f.gifu-u.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
岐阜県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 10 | 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 | 12 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using the AI-based educational tool Shabereru-n, we will conduct a survey to determine the extent to which communication skills and proficiency in pediatric nursing techniques have improved.
Management information
Registered date
| 2025 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068593
