UMIN-CTR Clinical Trial

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
Email	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
Email	jibika@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University
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	Ehime University Research Ethics Committee
Address	Shitukawa, Toon-city, Ehime
Tel	0899645111
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049648