UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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
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	2021 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date	2022 Year 06 Month 15 Day
Last follow-up date	2022 Year 12 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	2022 Year 06 Month 09 Day
Last modified on	2022 Year 06 Month 09 Day

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

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