UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049037 |
|---|---|
| Receipt number | R000055866 |
| Scientific Title | Collaborative remote learning program through using virtual reality environment that enhances clinical reasoning about living at home |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2025/03/31 17:24:57 |
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Basic information
Public title
Collaborative remote learning program through using virtual reality environment that enhances clinical reasoning about living at home
Acronym
Collaborative remote learning program through using virtual reality environment that enhances clinical reasoning about living at home
Scientific Title
Collaborative remote learning program through using virtual reality environment that enhances clinical reasoning about living at home
Scientific Title:Acronym
Collaborative remote learning program through using virtual reality environment that enhances clinical reasoning about living at home
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will develop simulation learning programs in which students remotely visit a subject's house reproduced in VR and VTR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Nursing students' self-assessment of clinical reasoning skills
Key secondary outcomes
All participants: Student Satisfaction and Self-Confidence in Learning, Simulation Design Scale (Student Version), Educational Practices Questionnaire (Student Version), Free description.
Only intervention group: VR sickness, Usability metric for user experience (UMUX)-LITE, igroup presence questionnaire (iPQ).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
using VR (three types)
Interventions/Control_2
watching the video (three types)
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
For the pilot study: nursing students are in the third or fourth grades in 2022. (To be held at two universities in Tokyo)
For the main RCT: nursing students will be in the third grade of the university in 2023. (To be held at one university in Tokyo)
Key exclusion criteria
Persons other than the above.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Yoshioka-Maeda |
Organization
The University of Tokyo
Division name
Department of Community Health Nursing, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku
TEL
0358413597
kyokoy-tky@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Yoshioka-Maeda |
Organization
The University of Tokyo
Division name
Department of Community Health Nursing, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1, Hongo, Bunkyo-ku
TEL
0358413597
Homepage URL
kyokoy-tky@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Metropolitan University, Mejiro University, National Institute of Public Health, National Institute of Advanced Industrial Science and Technology.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学（東京都）、東京都立大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 01 | 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
79
Results
Seventy-nine third-year nursing students participated in the study; one student who did not agree to provide data. We excluded this data for analysis.
Results date posted
| 2024 | Year | 09 | Month | 28 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to the under review of the manuscript.
Date of the first journal publication of results
Baseline Characteristics
Third-year nursing students
Participant flow
The study was conducted at the co-researcher's university as part of a third-year home care nursing training class. Since the learning effectiveness of the material was unknown, all students were randomly allocated into two groups for comparison to guarantee the opportunity for students to learn. Data were obtained from students who agreed to participate in the study.
Adverse events
No
Outcome measures
Nursing Students' Self-Assessment of Clinical Reasoning Skills
Student Satisfaction and Self-Confidence in Learning
Simulation Design Scale (Student Version)
Educational Practices Questionnaire (Student Version)
Free description
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 14 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
A pilot study: conducted in FY2022.
The main study was conducted in June 2023.
We submitted the manuscript and underreview (March 2025).
Management information
Registered date
| 2022 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055866
