UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053112 |
|---|---|
| Receipt number | R000060611 |
| Scientific Title | A crossover comparison study with tablet devices on the usefulness of a monitored VR system that can be used by bedridden patients |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2023/12/15 00:42:18 |
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Basic information
Public title
A crossover comparison study with tablet devices on the usefulness of a monitored VR system that can be used by bedridden patients
Acronym
A crossover comparative study on the usefulness of monitored VR systems
Scientific Title
A crossover comparison study with tablet devices on the usefulness of a monitored VR system that can be used by bedridden patients
Scientific Title:Acronym
A crossover comparative study on the usefulness of monitored VR systems
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the usefulness of our newly created monitored VR system through a crossover comparative study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in ESAS-J after the first and second video viewing from before viewing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The researcher will ask the subjects about the videos they wish to watch and select videos from YouTube. The videos will be searched and suggested on the spot according to the subject's wishes, and will not be conducted in a format in which the subject is asked to select only from a list prepared in advance by the researcher. Before subjects view the first video, their symptoms will be evaluated by ESAS-J. The subject will be presented with the video using a VR system or tablet for 10 minutes. After viewing the video, symptoms, satisfaction and adverse reactions ([headache, dizziness, enjoyment, satisfaction]) will be evaluated by ESAS-J and NRS. The immersive experience will also be evaluated by the IPQ, and the participants will provide their impressions to the researcher in an open-ended format. After a 1-hour washout period, subjects will be asked to rate their symptoms using the ESAS-J before viewing the second video. After viewing the video, the same evaluation as during the first viewing will be conducted.
Interventions/Control_2
After a 1-hour washout period, subjects will be evaluated by ESAS-J before viewing the second video, which will be the same as the first video but presented to them for 10 minutes using a different device (VR system or tablet). After viewing the video, the same evaluation as during the first viewing will be conducted.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are 20 years of age or older
Patients with cancer who are admitted to a palliative care unit
Patients who are under the care of a supportive care team.
Patients who can answer the questionnaire in writing or orally.
Patients who can communicate orally
Key exclusion criteria
Those who are under 20 years old.
Cognitive decline to the extent that they are unable to respond to the questionnaire.
Those who have difficulty in oral communication
Those with visual impairment
Those with hearing impairment
Those who self-report that they are prone to motion sickness.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Okamoto |
Organization
Ashiya Municipal Hospital
Division name
Pharmacy
Zip code
659-8502
Address
39-1, Asahigaoka-cho, Ashiya, Hyogo
TEL
0797-31-2156
okamoysh@phs.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Niki |
Organization
Ashiya Municipal Hospital
Division name
Pharmacy
Zip code
659-8502
Address
39-1, Asahigaoka-cho, Ashiya, Hyogo
TEL
0797-31-2156
Homepage URL
k-niki@phs.osaka-u.ac.jp
Sponsor or person
Institute
Ashiya Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ashiya Municipal Hospital
Address
39-1, Asahigaoka-cho, Ashiya, Hyogo
Tel
0797-31-2156
k-niki@phs.osaka-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
| 2023 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 12 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060611
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
