UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023948
Receipt number R000027304
Scientific Title Evaluation of educational effects of Chronobiological assessment on medical students
Date of disclosure of the study information 2016/09/06
Last modified on 2016/09/06 11:32:39

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Basic information

Public title

Evaluation of educational effects of Chronobiological assessment on medical students

Acronym

Chronobiological assessment in medical education

Scientific Title

Evaluation of educational effects of Chronobiological assessment on medical students

Scientific Title:Acronym

Chronobiological assessment in medical education

Region

Japan


Condition

Condition

Sleep Disorder

Classification by specialty

Psychiatry Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Prevention of repeating a year,dropping out is acute problem in medical education. This research aims to reveal as follow: (1)to examine relation between academic performance and by measuring the trait of circadian rhythm and the quality of sleep of medical student, (2)to evaluate of educational and mental effects of Chronobiological advice for student who have problems in the trait of circadian rhythm. We try to describe the methodology new aspect in medical student and the application for Chronobiological development.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Academic Record
(The end of the year)

Key secondary outcomes

University Personality Inventory
Munich ChronoType Questionnaire
Sleep Diary


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment Behavior,custom

Interventions/Control_1

sleep management and psychological counseling
once every two weeks

Interventions/Control_2

actiwatch and sleep scope
a week

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

Sex: No object

Key exclusion criteria

1.Students who participated in other clinical trials within four months
2.At the time of obtaining informed consent, students who have received the medication on sleep
3.students principal investigator has determined to be inappropriate as a research subject

Target sample size

75


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi ABE

Organization

University of Fukui

Division name

Division of Psychology,Faculty of Medical Sciences

Zip code


Address

23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan

TEL

0776613111

Email

hiroabe@u-fukui.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi ABE

Organization

University of Fukui

Division name

Matsuoka Campus, Student Support and Counseling Office

Zip code


Address

23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan

TEL

0776613111

Homepage URL


Email

nmaegawa@u-fukui.ac.jp


Sponsor or person

Institute

University of Fukui

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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

2016 Year 09 Month 06 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

No longer recruiting

Date of protocol fixation

2016 Year 08 Month 20 Day

Date of IRB


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



Other

Other related information



Management information

Registered date

2016 Year 09 Month 06 Day

Last modified on

2016 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027304


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name