UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050166 |
|---|---|
| Receipt number | R000057141 |
| Scientific Title | Effectiveness of a dementia educational program using virtual reality technology on the attitude of nursing students toward people living with dementia: A randomized controlled trial |
| Date of disclosure of the study information | 2023/01/28 |
| Last modified on | 2023/01/28 19:25:02 |
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Basic information
Public title
Effects of the dementia educational program using virtual reality (VR) for nursing students
Acronym
Effects of the dementia educational program using virtual reality (VR)
Scientific Title
Effectiveness of a dementia educational program using virtual reality technology on the attitude of nursing students toward people living with dementia: A randomized controlled trial
Scientific Title:Acronym
Effectiveness of a dementia educational program using virtual reality technology on the attitude of nursing students toward people living with dementia
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a dementia educational program using virtual reality (VR) of nursing students on attitude toward people living with dementia, intention of helping behavior, and knowledge of dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The attitude measured by Attitude toward People with Dementia after intervention program
Key secondary outcomes
1) Intention of helping behavior for people living with dementia
2) Knowledge of dementia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The dementia educational program utilizing short films and videos with virtual reality (VR) technology will be delivered to nursing students in their classes. This program includes (1) short film about people with dementia and their families, (2) VR video that allows students to experience the perspective of a person with dementia, and (3) discussions about responses and impressions after watching the short film and VR. The lectures consist of 50 minutes.
Interventions/Control_2
The dementia educational program using the card game (N-impro) to discuss responses toward people living with dementia will be delivered to nursing students in their classes. The lectures consist of 50 minutes.
Interventions/Control_3
The educational program using the card game (Moshi-bana game) to discuss decision-making at the end of life will be delivered to nursing students in their classes. The lectures consist of 50 minutes.
Interventions/Control_4
The dementia educational program utilizing short films and videos with virtual reality (VR) technology will be delivered to nursing students in their classes. This program includes (1) short film about people with dementia and their families, (2) VR video that allows students to experience the perspective of a person with dementia, (3) discussions about responses and impressions after watching the short film and VR, and (4) card game (N-impro) to discuss responses toward people living with dementia. The lectures consist of 100 minutes.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Second-year nursing students from a university in Kanagawa Prefecture who wish to participate in this program
Key exclusion criteria
1) Those who do not agree with the purpose of this study
2) Those who are absent from the lecture on the day conducting this program
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Igarashi |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3507
aigarashi@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Haruno |
| Middle name | |
| Last name | Suzuki |
Organization
The University of Tokyo
Division name
Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3508
Homepage URL
haruno@m.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
MEXT
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
The University of Tokyo, Clinical Research Review Board
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 28 | 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
108
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
| 2022 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057141
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| Registered date | File name |
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