UMIN-CTR Clinical Trial

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
Email	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
Email	k-niki@phs.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034148