UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043507
Receipt number R000049682
Scientific Title Usefulness of simulation training for medical students
Date of disclosure of the study information 2021/04/27
Last modified on 2023/04/24 12:59:08

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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 or person

Institute

Okayama University Hospital

Institute

Department

Personal name



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

No longer recruiting

Date of protocol fixation

2021 Year 04 Month 27 Day

Date of IRB

2021 Year 04 Month 27 Day

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

2023 Year 03 Month 31 Day

Date analysis concluded

2023 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 03 Month 03 Day

Last modified on

2023 Year 04 Month 24 Day



Link to view the page

Value
https://center6.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