UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000052131
Receipt number R000059502
Scientific Title Development of an application to support education on multi-tasking for nurses using VR
Date of disclosure of the study information 2023/09/06
Last modified on 2023/09/06 17:07:59

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Basic information

Public title

Development of an application to support education on multi-tasking for nurses using VR

Acronym

Research on multi-tasking for nurses using VR

Scientific Title

Development of an application to support education on multi-tasking for nurses using VR

Scientific Title:Acronym

Research on multi-tasking for nurses using VR

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the characteristics of brain activity of experienced nurses and nursing students during multiple-task experiences in a virtual space through observational research.

Basic objectives2

Others

Basic objectives -Others

Biological characteristics

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

BOLD signal measured by fMRI

Key secondary outcomes

Total hemoglobin changes measured by NIRS


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

Male and Female

Key inclusion criteria

Nursing students and experienced nurses with at least five years of work experience in hospitals.

Key exclusion criteria

1) Those with metal in their bodies, are afraid of dark or claustrophobic places, and pregnant women. (because the experiment will be conducted under high magnetism and in a confined space)
2) Those who dropped out from the experiment due to unforeseen reasons.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Oyama

Organization

The University of Tokyo

Division name

Graduate School of Medicine, Department of Clinical Information Engineering

Zip code

113-0033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-5841-1893

Email

cie-office@umin.ac.jp


Public contact

Name of contact person

1st name Koki
Middle name
Last name Ono

Organization

The University of Tokyo

Division name

Graduate School of Medicine, Department of Clinical Information Engineering

Zip code

113-0033

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-5841-1893

Homepage URL

http://webpark1893.sakura.ne.jp/wp/researches/

Email

multitask.fmri@gmail.com


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Committee of the Faculty of Medicine of the University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

Tel

03-5841-0818

Email

ethics@m.u-tokyo.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

東京大学


Other administrative information

Date of disclosure of the study information

2023 Year 09 Month 06 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

Open public recruiting

Date of protocol fixation

2022 Year 10 Month 01 Day

Date of IRB

2023 Year 04 Month 25 Day

Anticipated trial start date

2023 Year 07 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2023 Year 09 Month 06 Day

Last modified on

2023 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059502