UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011043
Receipt number R000012926
Scientific Title A health survey of fatigue due to VDT work
Date of disclosure of the study information 2013/06/25
Last modified on 2019/01/19 16:14:54

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Basic information

Public title

A health survey of fatigue due to VDT work

Acronym

A health survey of fatigue due to VDT work

Scientific Title

A health survey of fatigue due to VDT work

Scientific Title:Acronym

A health survey of fatigue due to VDT work

Region

Japan


Condition

Condition

none

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Recently, VDT work is diversified.
We will analyze mode of fatigue, when different types of VDT work are conducted.

Basic objectives2

Others

Basic objectives -Others

Recently, VDT work is diversified.
We will analyze mode of fatigue, when different types of VDT work are conducted.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

questionnaire examining fatigue

Key secondary outcomes

non-invasive physiological examination


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

surveillance work

Interventions/Control_2

key in work

Interventions/Control_3

dialogue type work

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

20 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

healthy male and female volunteers whose age is from 20 to 65 years old

Key exclusion criteria

hisstory of lasik operation and a person who has an inappropriate history of eye diseases

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masashi Tsunoda

Organization

National Defense Medical College

Division name

Department of Preventive Medicine and Public Health

Zip code


Address

Namiki 3-2, Tokorozawa, Saitama, Japan

TEL

04-2995-1563

Email

mtsunoda@ndmc.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Nakashima

Organization

National Defense Medical College

Division name

Department of Preventive Medicine and Public Health

Zip code


Address

Namiki 3-2, Tokorozawa, Saitama, Japan

TEL

04-2995-1563

Homepage URL


Email

hnakashi@ndmc.ac.jp


Sponsor or person

Institute

National Defense Medical College

Institute

Department

Personal name



Funding Source

Organization

National Defense Medical College

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2013 Year 06 Month 25 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

Completed

Date of protocol fixation

2013 Year 04 Month 11 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 27 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 06 Month 25 Day

Last modified on

2019 Year 01 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012926


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name