UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048018 |
|---|---|
| Receipt number | 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 | 2023/06/16 09:13:41 |
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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
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing | Not applicable | Adult |
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
| Behavior,custom |
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
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
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
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Emi |
| Middle name | |
| Last name | Tahara-Sasagawa |
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
| 1st name | Emi |
| Middle name | |
| Last name | Tahara-Sasagawa |
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 or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
| 2022 | Year | 06 | Month | 15 | 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
41
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 09 | Day |
Last modified on
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054730
