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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000048018 |
Receipt No. | R000054730 |
Scientific Title | Exploring the impact of visualization technology on midwifery student learning of the third stage of labor |
Date of disclosure of the study information | 2022/06/15 |
Last modified on | 2022/06/09 |
Basic information | ||
Public title | Exploring the impact of visualization technology on midwifery student learning of the third stage of labor | |
Acronym | Exploring the impact of visualization technology on midwifery student learning of the third stage of labor | |
Scientific Title | Exploring the impact of visualization technology on midwifery student learning of the third stage of labor | |
Scientific Title:Acronym | Exploring the impact of visualization technology on midwifery student learning of the third stage of labor | |
Region |
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Condition | ||||
Condition | Not applicable | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | This study investigates whether VR helps to understand physiology of the third stage of labor |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Evaluate the difference in acquisition of knowledge between "VR education group" and "Standard teaching group." |
Key secondary outcomes | Evaluate the difference in knowledge retention between the "VR education followed by standard education group" and "standard education followed by VR education group." |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Educational,Counseling,Training | |
Type of intervention |
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Interventions/Control_1 | The participants experience the VR education (8 min x 1) followed by standard education (8 min x1). | |
Interventions/Control_2 | The participants experience the Standard education (8 min x 1) followed by VE education (8 min x 1) | |
Interventions/Control_3 | ||
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Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | Healthy midwifery Japanese students over twenty years old | |||
Key exclusion criteria | -Unable to provide individual consent
-Unable to read and write in Japanese -In poor health condition -with visual and hearing disabilities |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | The University of Tokyo | ||||||
Division name | Department of Midwifery and Women's Health | ||||||
Zip code | 113-0033 | ||||||
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo | ||||||
TEL | 0358413396 | ||||||
e-sasagawa@g.ecc.u-tokyo.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | The University of Tokyo | ||||||
Division name | Department of Midwifery and Wome's Health | ||||||
Zip code | 113-0033 | ||||||
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo | ||||||
TEL | 0358413396 | ||||||
Homepage URL | |||||||
e-sasagawa@g.ecc.u-tokyo.ac.jp |
Sponsor | |
Institute | The University of Tokyo |
Institute | |
Department |
Funding Source | |
Organization | Pfizer Health Research foundation |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | University of the Sunshine Coast (USC), Australia |
Name of secondary funder(s) | Waikato Institute of Technology (WINTEC), New Zealand |
IRB Contact (For public release) | |
Organization | The University of Tokyo, Clinical Research Review Board |
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo |
Tel | 03-5841-0818 |
ethics@m.u-tokyo.ac.jp |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | A211569 |
Org. issuing International ID_1 | University of the Sunshine Coast; Human Research Ethics Committee of the University of the Sunshine Coast. |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054730 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |