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 | 2025/03/06 23:31:32 |
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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
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
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
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
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
39
Results
Simulation training on vascular interventions significantly enhanced knowledge acquisition among medical students compared to the group without simulation. In a comparative study between two groups, those who underwent lecture followed by simulation training demonstrated early knowledge acquisition and increased interest in vascular interventions.
Results date posted
| 2025 | Year | 03 | Month | 06 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Currently being submitted to an academic journal
Date of the first journal publication of results
Baseline Characteristics
Medical students who trained in our department between February 2021 and August 2022 were included in this study.
Participant flow
The study period targeted medical students who participated in a four-week rotation in the Department of Neurological Surgery at our hospital between February 2021 and August 2022. Participants were randomly assigned to three groups (1:1:1): the Lecture (LEC)-only group, the LEC-first group, and the Simulation (SIM)-first group (Figure 1).
Adverse events
None
Outcome measures
Changes before and after the training were compared between each group in terms of self-evaluation of motivation to learn, knowledge test, skill evaluation, evaluation of the simulation training, and interest in endovascular neurointervention.
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
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049682
