UMIN-CTR Clinical Trial

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