UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056096 |
|---|---|
| Receipt number | R000064091 |
| Scientific Title | Verification of the Effectiveness of an Oral Care Infection Control Program Using VR in Nursing home |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2024/11/08 09:55:30 |
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Basic information
Public title
Research on Infection Control in Nursing home
Acronym
Research on Infection Control in Nursing home
Scientific Title
Verification of the Effectiveness of an Oral Care Infection Control Program Using VR in Nursing home
Scientific Title:Acronym
Verification of the Effectiveness of an Oral Care Infection Control Program Using VR in Nursing home
Region
| Japan |
Condition
Condition
Nursing home staff
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct a program based on a VR experience that encourages nursing home staff to visualize bacteria and to determine the impact on infection prevention behavior during oral care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic attributes (age, gender, years of clinical experience, highest level of education)
Before implementing the program, participants will be asked to fill out an anonymous questionnaire.
This study aims to implement a program based on a VR experience that promotes the visualization of bacteria for elderly care facility staff, and to clarify the impact of this program on infection prevention behavior during oral care. Therefore, the following items will be collected before and after the intervention program.
Rate of wearing appropriate personal protective equipment during oral care, rate of hand hygiene during oral care, and rate of compliance with procedures
Remaining amount of portable hand sanitizer
The nursing facility manager will be interviewed before and after the intervention regarding the remaining amount of disinfectant carried by the subjects (provided individually each month by the nursing facility).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A group of infection control programs based on the VR experience. Each program is scheduled for 60 minutes.
Interventions/Control_2
A group of text-based lectures on infection control. Each program is scheduled for 60 minutes.
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
Staff providing oral care in nursing homes
Key exclusion criteria
Subjects with VR sickness
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Makiko |
| Middle name | |
| Last name | Yamamoto |
Organization
Kumamoto University
Division name
Faculty of Life Sciences Course of Nursing
Zip code
862-0976
Address
4-24-1,Kuhonji,Chuo-ku,Kumamoto
TEL
0963736123
mayamamoto@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Makiko |
| Middle name | |
| Last name | Yamamoto |
Organization
Kumamoto University
Division name
Faculty of Life Sciences Course of Nursing
Zip code
862-0976
Address
4-24-1,Kuhonji,Chuo-ku,Kumamoto
TEL
0963736123
Homepage URL
mayamamoto@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Socirty for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University
Address
4-24-1,Kuhonji,Chuo-ku,Kumamoto
Tel
0963736123
mayamamoto@kumamoto-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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2027 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064091
