UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043485 |
|---|---|
| Receipt number | R000049648 |
| Scientific Title | Development of otolaryngologic simulation training curriculum for medical students |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/04/06 17:45:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of otolaryngologic simulation training curriculum for medical students
Acronym
Development of otolaryngologic simulation training curriculum for medical students
Scientific Title
Development of otolaryngologic simulation training curriculum for medical students
Scientific Title:Acronym
Development of otolaryngologic simulation training curriculum for medical students
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy of an otolaryngologic simulation training curriculum for medical students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A questionnaire before and after completing the otolaryngologic simulation training curriculum.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Training based on an otolaryngologic simulation training curriculum.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
5th and 6th grade medical students in Ehime University School of Medicine participating clinical clerkship in otolaryngology department.
Key exclusion criteria
None
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Sato |
Organization
Ehime University
Division name
Otolaryngology
Zip code
7910295
Address
Shitukawa, Toon-city, Ehime
TEL
0899605366
jibika@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Sato |
Organization
Ehime University
Division name
Otolaryngology
Zip code
7910295
Address
Shitukawa, Toon-city, Ehime
TEL
0899605366
Homepage URL
jibika@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
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
Ehime University Research Ethics Committee
Address
Shitukawa, Toon-city, Ehime
Tel
0899645111
rinri@m.ehime-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 | 03 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 03 | 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
Management information
Registered date
| 2021 | Year | 03 | Month | 01 | Day |
Last modified on
| 2021 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049648
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
