UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057145 |
|---|---|
| Receipt number | R000065329 |
| Scientific Title | A non-blinded randomized controlled trial comparing the effectiveness of stoma self-care education using VR (Virtual Reality) content with conventional education methods for patients with stomas |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/02/27 11:39:07 |
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Basic information
Public title
A non-blinded randomized controlled trial comparing the effectiveness of stoma self-care education using VR (Virtual Reality) content with conventional education methods for patients with stomas
Acronym
A non-blinded randomized controlled trial comparing the effectiveness of stoma self-care education using VR (Virtual Reality) content with conventional education methods for patients with stomas
Scientific Title
A non-blinded randomized controlled trial comparing the effectiveness of stoma self-care education using VR (Virtual Reality) content with conventional education methods for patients with stomas
Scientific Title:Acronym
A non-blinded randomized controlled trial comparing the effectiveness of stoma self-care education using VR (Virtual Reality) content with conventional education methods for patients with stomas
Region
| Japan |
Condition
Condition
Stoma construction patient
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to create VR content for use in stoma self-care education for patients who have had a stoma constructed, and to compare the effectiveness of education using this content with the effectiveness of education using conventional pamphlets alone.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of days until stoma self-care is mastered
Key secondary outcomes
Stoma-QOL score
Hours spent by nurses on stoma self-care education
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Watching VR content
Interventions/Control_2
Receive smart self-care education using pamphlets that have been used in the past.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who have given their consent freely after being given an explanation about this research using an explanatory document
2. Those aged 18 years or over
3. Those who will have a gastrointestinal stoma created at the Department of Gastroenterological Surgery, Nippon Medical School Hospital
4. Those who are eligible for the pass
Key exclusion criteria
1. Those whose purpose is to create a temporary stoma (e.g. terminal patients)
2. Others who the principal investigator or sub-investigators deem unsuitable for participation in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Seiichi |
| Middle name | |
| Last name | Shinji |
Organization
Nippon Medical School Hospital
Division name
Department of Gastroenterological surgery
Zip code
1138603
Address
1-1-5, Sendagi, Bunkyoku, Tokyo
TEL
0338222131
s-shinji@nms.ac.jp
Public contact
Name of contact person
| 1st name | Seiichi |
| Middle name | |
| Last name | Shinji |
Organization
Nippon Medical School Hospital
Division name
Department of Gastroenterological surgery
Zip code
1138603
Address
1-1-5, Sendagi, Bunkyoku, Tokyo
TEL
0338222131
Homepage URL
s-shinji@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Central Ethics Committee of the Nippon Medical School Foundation
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
0338222131
chuorinri.group@nms.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 | 02 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065329
