UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055453 |
|---|---|
| Receipt number | R000063363 |
| Scientific Title | Development of VR teaching materials to enhance awareness of disorders of consciousness and verification of effectiveness of educational intervention |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2026/03/10 09:06:31 |
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Basic information
Public title
Development of VR teaching materials to enhance awareness of disorders of consciousness and verification of effectiveness of educational intervention
Acronym
Development of VR teaching materials to enhance awareness of disorders of consciousness and verification of effectiveness of educational intervention
Scientific Title
Development of VR teaching materials to enhance awareness of disorders of consciousness and verification of effectiveness of educational intervention
Scientific Title:Acronym
Development of VR teaching materials to enhance awareness of disorders of consciousness and verification of effectiveness of educational intervention
Region
| Japan |
Condition
Condition
Nursing Students' Perceptions of Patients with Consciousness Disorders
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of VR educational materials to promote awareness of patients with disorders of consciousness in nursing education, we will conduct an educational intervention with fourth-year undergraduate nursing students prior to their integrated practice, using the VR teaching materials to be developed. Specifically, we will create a checklist of "awareness" skills based on the educational objectives obtained through qualitative research in the primary study, and verify its effectiveness in improving nursing students' awareness of the emergence of disorders of consciousness. Based on the results of surveys conducted by the intervention and waiting groups, we will examine the effectiveness of the VR teaching materials as an educational method to promote awareness of patients' disorders of consciousness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In a nursing practice simulation with simulated patients, the primary outcome is the students' ability to accurately recognize signs of consciousness disorders from the free description list immediately after the VR-based educational intervention.
Key secondary outcomes
Students' actions will be recorded with 360-degree and fixed cameras during the intervention and later analyzed for evaluation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group will undergo an educational intervention using VR materials aimed at improving awareness skills regarding disorders of consciousness. Specifically, a 10-minute lecture will first be given to provide basic knowledge about consciousness disorders. Following this, participants will watch a VR video (5-10 minutes) created based on scenarios developed from the findings of the primary study. The VR material is designed to enhance understanding by comparing signs of patients developing consciousness disorders.
Interventions/Control_2
As Intervention 2, a skills check test will be conducted using simulated patients in a nursing practice setting. Students will be evaluated on their ability to notice signs of consciousness disorders and perform appropriate nursing practices. After the practice, students will complete a free description list, and researchers will objectively evaluate their skills using a behavior evaluation sheet.
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Third- or fourth-year nursing students enrolled at a university in Aichi Prefecture.
2.Must have completed all specialized practicums.
3.Students must be before their integrated practice.
4.Must have provided consent to participate in the study.
Key exclusion criteria
1.Students who do not consent to participate in the study.
2.Students who have already started their integrated practice.
3.Students who are unable to watch the VR materials due to physical or mental limitations.
4.Students who have not completed the credits for all specialized practicums.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | AKIKO |
| Middle name | |
| Last name | ENOMOTO |
Organization
Graduate School of Human Environment
Division name
Graduate School of Nursing
Zip code
4740035
Address
3-220 Ebata-cho, Obu-shi, Aichi, Japan
TEL
0562430701
a-enomoto@uhe.ac.jp
Public contact
Name of contact person
| 1st name | AKIKO |
| Middle name | |
| Last name | ENOMOTO |
Organization
Graduate School of Nursing
Division name
Graduate School of Nursing
Zip code
4740035
Address
3-220 Ebata-cho, Obu-shi, Aichi, Japan
TEL
0562430701
Homepage URL
a-enomoto@uhe.ac.jp
Sponsor or person
Institute
Faculty of Nursing, University of Human Environment
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
College of Nursing Library, University of Human Environments
Address
3-220 Ebata-cho, Obu-shi, Aichi, Japan
Tel
0562430701
a-enomoto@uhe.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
| 2024 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
34
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
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 09 | Month | 07 | Day |
Last modified on
| 2026 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063363
