UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041067
Receipt number 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 19:04:26

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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

Obstetrics 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 or person

Institute

Osaka University

Institute

Department

Personal name



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

Value
https://center6.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