UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000054253
Receipt number R000061954
Scientific Title Investigating Fatigue in Online Classes Among University Students
Date of disclosure of the study information 2024/04/25
Last modified on 2024/04/25 01:06:42

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Basic information

Public title

Investigating Fatigue in Online Classes Among University Students

Acronym

Investigating Fatigue in Online Classes Among University Students

Scientific Title

Investigating Fatigue in Online Classes Among University Students

Scientific Title:Acronym

Fatigue in Online Classes

Region

Japan


Condition

Condition

fatigue syndrome

Classification by specialty

Ophthalmology Orthopedics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluating the relationship between the duration of digital device use and online classes, and physical and eye fatigue.

Basic objectives2

Others

Basic objectives -Others

Creating a Manual for Watching Online Classes

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Respondent Attributes
Digital Device Usage
Physical Fatigue from Online Classes
Eye Fatigue from Online Classes
Use of Glasses and Contact Lenses

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

Other

Interventions/Control_1

survey

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

18 years-old <

Age-upper limit

26 years-old >=

Gender

Male and Female

Key inclusion criteria

university students enrolled in online courses

Key exclusion criteria

"No exclusion criteria

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name MASAKO
Middle name
Last name ISHII

Organization

Niigata University of Health and Welfare

Division name

Social Collaboration Promotion Organization

Zip code

950-3198

Address

1398 Shimamicho, Kita Ward, Niigata City, Niigata Prefecture, Japan

TEL

+819030943531

Email

ishii@nuhw.ac.jp


Public contact

Name of contact person

1st name MASAKO
Middle name
Last name ISHII

Organization

Niigata University of Health and Welfare

Division name

Social Collaboration Promotion Organization

Zip code

950-3198

Address

1398 Shimami-cho, Kita-ku, Niigata-shi

TEL

+819030943531

Homepage URL


Email

ishii@nuhw.ac.jp


Sponsor or person

Institute

1398 Shimami-cho, Kita-ku, Niigata-shi

Institute

Department

Personal name



Funding Source

Organization

Niigata University of Health and Welfare

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

Niigata University of Health and Welfare

Address

1398 Shimami-cho, Kita-ku, Niigata-shi

Tel

+819030943531

Email

ishii@nuhw.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

2024 Year 04 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

Preinitiation

Date of protocol fixation

2021 Year 11 Month 30 Day

Date of IRB

2021 Year 07 Month 30 Day

Anticipated trial start date

2024 Year 05 Month 30 Day

Last follow-up date

2027 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

2024 Year 04 Month 25 Day

Last modified on

2024 Year 04 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061954


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name