Unique ID issued by UMIN | UMIN000041067 |
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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 |
Development of preventive procedures against side effects and stress during TC therapy using Virtual Reality
Evaluation of effectiveness of VR during TC therapy
Evaluation of the effectiveness of VR as a method of reducing side effects in TC therapy
Evaluation of effectiveness of VR during TC therapy
Japan |
Gynecologic Cancers
Obstetrics and Gynecology |
Malignancy
NO
To evaluate the effectiveness of Virtual reality (VR) experience for decreasing side effects of TC chemotherapy
Efficacy
Change of ESAS-r-J scores during the 1st course
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Other |
VR experience during TC therapy
control
20 | years-old | <= |
Not applicable |
Female
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
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
60
1st name | Yutaka |
Middle name | |
Last name | Ueda |
Gynecology and Obstetrics
Graduate School of Medicine
565-0871
2-2 Yamadaoka Suitashi, Osaka
06-6879-3351
y.ueda@gyne.med.osaka-u.ac.jp
1st name | Kazuyuki |
Middle name | |
Last name | Niki |
Medical and Pharmaceutical Sciences
Graduate School of Pharmaceutical Sciences
565-0871
6-1 Yamadaoka Suitashi, Osaka
06-6879-8250
k-niki@phs.osaka-u.ac.jp
Osaka University
self funding
Self funding
Osaka University Clinical Research Review Committee
2-2 Yamadaoka Suitashi, Osaka
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
NO
2020 | Year | 08 | Month | 01 | Day |
Unpublished
Preinitiation
2020 | Year | 05 | Month | 11 | Day |
2020 | Year | 08 | Month | 01 | Day |
2023 | Year | 03 | Month | 31 | Day |
2020 | Year | 07 | Month | 10 | Day |
2020 | Year | 07 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046892
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