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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041067
Receipt No. R000046892
Scientific Title Evaluation of the effectiveness of VR as a method of reducing side effects in TC therapy
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/10

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Basic information
Public title Development of preventive procedures against side effects and stress during TC therapy using Virtual Reality
Acronym Evaluation of effectiveness of VR during TC therapy
Scientific Title Evaluation of the effectiveness of VR as a method of reducing side effects in TC therapy
Scientific Title:Acronym Evaluation of effectiveness of VR during TC therapy
Region
Japan

Condition
Condition Gynecologic Cancers
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of Virtual reality (VR) experience for decreasing side effects of TC chemotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of ESAS-r-J scores during the 1st course
Key secondary outcomes 1.ESAS-r-J nausea scores and IPOS nausea/vomiting scores just before the 2nd course
2.Change of NRS scores
3.Complete response rates of nausea/vomiting
4.Outpatient transition rate for the 2nd course
5.Change of [STAI]Y-1 scores
6.Change of STAI Y-2 scores during the 1st course
7.LF/HF ratio during VR experience
8.NRS scores for side effects of VR
9.Difference in average health care costs between the two groups
10.Impressions after the VR experience on day7

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 VR experience during TC therapy
Interventions/Control_2 control
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 Female
Key inclusion criteria 1. 20 years of age or older
2. Being admitted to the Obstetrics and Gynecology ward of our hospital
3. Undergoing TC therapy
4) Informed consent to participate in this study
Key exclusion criteria 1. Uunder 20 years of age.
2. Visual impairment.
3. Hearing impairment
4. Prone to motion sickness or visually-induced sickness
5. Difficulty in sitting
6. Cognitive impairment
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Ueda
Organization Gynecology and Obstetrics
Division name Graduate School of Medicine
Zip code 565-0871
Address 2-2 Yamadaoka Suitashi, Osaka
TEL 06-6879-3351
Email y.ueda@gyne.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Kazuyuki
Middle name
Last name Niki
Organization Medical and Pharmaceutical Sciences
Division name Graduate School of Pharmaceutical Sciences
Zip code 565-0871
Address 6-1 Yamadaoka Suitashi, Osaka
TEL 06-6879-8250
Homepage URL
Email k-niki@phs.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka University Clinical Research Review Committee
Address 2-2 Yamadaoka Suitashi, Osaka
Tel 06-6210-8296
Email rinri@hp-crc.med.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
2020 Year 08 Month 01 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
2020 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2023 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
2020 Year 07 Month 10 Day
Last modified on
2020 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046892

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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