UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Application, evaluation and psychological effects of computer-assisted education materials
Title of the study (Brief title)	Application, evaluation and psychological effects of computer-assisted education materials
Region	Japan

Condition
Condition	healthy subject
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clarify the educational and psychological effects of Computer-assisted education materials.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Conduct a psychological test before learning, and conduct a psychological test, a quiz for measuring the leaning effects and a survey for evaluating the materials after learning with the materials.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Interactive type material group: Before learning with an interactive type material, a psychological test will be performed, and after learning, a quiz for evaluating learning effects, and a questionnaire for evaluation of the materials will be performed. These will be used to compare the student performances and learning history, and to analyze their educational and psychological effects.
Interventions/Control_2	Display type material group (control): Before learning with a display type material, a psychological test will be performed, and after learning, a quiz for evaluating learning effects, and a questionnaire for evaluation of the materials will be performed. These will be used to compare the student performances and learning history, and to analyze their educational and psychological effects.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Students and faculty members at educational or medical institutes that carry out computer simulation material practice who agree with this study.
Key exclusion criteria	Those who didn't agree with the study.
Target sample size	150

Research contact person
Name of lead principal investigator	Atsuhiro Kinoshita
Organization	Tokyo Medical and Dental University
Division name	Department of Educational Media Development
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-4643
Email	kinoshita.emdv@tmd.ac.jp

Public contact
Name of contact person	Atsuhiro Kinoshita
Organization	Tokyo Medical and Dental University
Division name	Department of Educational Media Development
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-4643
Homepage URL
Email	kinoshita.emdv@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2016 Year 08 Month 08 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 08 Day
Last modified on	2018 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027121