UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023077
Receipt number R000026599
Scientific Title Creation and evaluation of a skills program for correcting the way to hold an instrument.
Date of disclosure of the study information 2016/07/08
Last modified on 2016/07/08 13:26:04

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Basic information

Public title

Creation and evaluation of a skills program for correcting the way to hold an instrument.

Acronym

Creation and evaluation of a skills program for correcting the way to hold an instrument.

Scientific Title

Creation and evaluation of a skills program for correcting the way to hold an instrument.

Scientific Title:Acronym

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.


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



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

1st name
Middle name
Last name Suzuki Tetsuya

Organization

Tokyo medical and dental university

Division name

Oral Prosthetic Engineering

Zip code


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

1st name
Middle name
Last name fukawa kouichi

Organization

Tokyo medical and dental university

Division name

Oral Prosthetic Engineering

Zip code


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 or person

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

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Preinitiation

Date of protocol fixation

2016 Year 07 Month 08 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026599


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name