UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Creation and evaluation of a skills program for correcting the way to hold an instrument.
Title of the study (Brief title)	Creation and evaluation of a skills program for correcting the way to hold an instrument.
Region	Japan

Condition
Condition	adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Relationship between the way to hold the instrument and the work efficiency.
Basic objectives2	Others
Basic objectives -Others	Evaluation of feedback education
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Differences of the working time caused by the way if holding the instrument. ( 5 minutes)
Key secondary outcomes	Figure of holding the instrument properly and improperly.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	Comparison of work efficiency between proper and improper way to hold the instrument.
Interventions/Control_2	Comparison of educational effects between instruction with and without the textbook.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	19 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Student holding the instrument improperly
Key exclusion criteria	Student holding the instrument properly
Target sample size	14

Research contact person
Name of lead principal investigator	Suzuki Tetsuya
Organization	Tokyo medical and dental university
Division name	Oral Prosthetic Engineering
Address	5-45 Yushima 1-chome, Bunkyo-ku Tokyo, 113-8549, JAPAN
TEL	03-5803-5780
Email	suzuki.peoe@tmd.ac.jp

Public contact
Name of contact person	fukawa kouichi
Organization	Tokyo medical and dental university
Division name	Oral Prosthetic Engineering
Address	5-45 Yushima 1-chome, Bunkyo-ku Tokyo, 113-8549, JAPAN
TEL	03-5803-5455
Homepage URL
Email	fukawa.peoe@tmd.ac.jp

Sponsor
Institute	Tokyo medical and dental university, Life Science and Bioethics Research Center, 5-45 Yushima 1-chome, Bunkyo-ku Tokyo, 113-8549 JAPAN 03-5803-4724
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Tokyo medical and dental university Oral Prosthetic Engineering
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 07 Month 08 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 08 Day
Anticipated trial start date	2016 Year 07 Month 08 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

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

Management information
Registered date	2016 Year 07 Month 08 Day
Last modified on	2016 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026599