UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029893 |
|---|---|
| Receipt number | R000034148 |
| Scientific Title | The investigation for establishment of a new approach in palliative care using Virtual Reality |
| Date of disclosure of the study information | 2017/11/09 |
| Last modified on | 2020/11/11 09:14:18 |
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Basic information
Public title
The investigation for establishment of a new approach in palliative care using Virtual Reality
Acronym
The investigation for establishment of a new approach in palliative care using Virtual Reality
Scientific Title
The investigation for establishment of a new approach in palliative care using Virtual Reality
Scientific Title:Acronym
The investigation for establishment of a new approach in palliative care using Virtual Reality
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, I aim to verify whether the approach using VR in palliative care has the possibility to contribute to the improvement of quality of life of end-of-life patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change amount of Edmonton Symptom Assessment System score before and after VR experience
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Virtual Reality experience
Interventions/Control_2
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
Patients admitted to a palliative care unit and inpatient patients intervened by palliative care team
Key exclusion criteria
Visually impaired / hearing impaired patients, patients who can not evaluate mental symptoms, patients with high cognitive impairment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Niki |
Organization
Osaka University/Ashiya Municipal Hospital
Division name
Graduate School of Pharmaceutical Sciences/Department of Pharmacy
Zip code
Address
Osaka, Suita, Yamadaoka1-6/Hyogo, Ashiya, Asahigaokacho 39-1
TEL
06-6879-8250
k-niki@phs.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Niki |
Organization
Osaka University/Ashiya Municipal Hospital
Division name
Graduate School of Pharmaceutical Sciences/Department of Pharmacy
Zip code
Address
Osaka, Suita, Yamadaoka1-6/Hyogo, Ashiya, Asahigaokacho 39-1
TEL
06-6879-8250
Homepage URL
k-niki@phs.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
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
Address
Tel
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
| 2017 | Year | 11 | Month | 09 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 11 | Month | 09 | Day |
Last modified on
| 2020 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034148
