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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043507
Receipt No. R000049682
Scientific Title Usefulness of simulation training for medical students
Date of disclosure of the study information 2021/04/27
Last modified on 2021/03/03

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Basic information
Public title Usefulness of simulation training for medical students
Acronym Usefulness of simulation training for medical students
Scientific Title Usefulness of simulation training for medical students
Scientific Title:Acronym Usefulness of simulation training for medical students
Region
Japan

Condition
Condition Medical students
Classification by specialty
Neurosurgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Validating the usefulness of simulation training for medical students using 3D vascular models
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Evaluation of interest in and understanding of neurosurgery through a questionnaire

Key secondary outcomes (2) Percentage of correct answers in a written test
(3) Level of achievement in the simulation training

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment Maneuver Other
Interventions/Control_1 Lecture on Neurological surgery
Interventions/Control_2 (1) Lecture on Neurological surgery
(2) Hands-on training by using 3D models
Interventions/Control_3 (1) Hands-on training by using 3D models
(2) Lecture on Neurological surgery
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Medical students who have completed clinical training at the Department of Neurological surgery, Okayama University Hospital during the period from the approval by the Ethics Committee to December 31, 2022 are eligible.
Key exclusion criteria Those that were unable to participate in all of the scheduled training or refused the survey
Target sample size 30

Research contact person
Name of lead principal investigator
1st name KENJI
Middle name
Last name SUGIU
Organization Okayama University Hospital

Division name IVR Center, Neurological Surgery
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-7336
Email ksugiu@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name YUKI
Middle name
Last name EBISUDANI
Organization Okayama University Hospital
Division name Neurological Surgery
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-7336
Homepage URL
Email yebis.0927@gmail.com

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
Tel 086-235-6503
Email mae6605@adm.okayama-u.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

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 27 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 04 Month 27 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 27 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
2021 Year 03 Month 03 Day
Last modified on
2021 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049682

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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