UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023365 |
|---|---|
| Receipt number | R000026918 |
| Scientific Title | Investigation of the influences of sleep and exercise on the mental health of medical students and junior residents |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2019/05/01 09:51:27 |
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Basic information
Public title
Investigation of the influences of sleep and exercise on the mental health of medical students and junior residents
Acronym
Investigation of the influences of sleep and exercise on the mental health of medical students and junior residents
Scientific Title
Investigation of the influences of sleep and exercise on the mental health of medical students and junior residents
Scientific Title:Acronym
Investigation of the influences of sleep and exercise on the mental health of medical students and junior residents
Region
| Japan |
Condition
Condition
Medical students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the influences of daily life such as sleep and exercise on the mental health of medical students and junior residents
Basic objectives2
Others
Basic objectives -Others
Influences
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Sleep and exercise estimated by wearable device and mental health questionnaire responses during two and half years
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
Prevention
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Wearable device
Mental health questionnaire
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Final-year medical students at Tokyo Medical and Dental University
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhide Hirai |
Organization
Tokyo Medical and Dental University
Division name
Student Support and Health Administration Organization
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5079
hokencenter.hsc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhide Hirai |
Organization
Tokyo Medical and Dental University
Division name
Student Support and Health Administration Organization
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5803-5079
Homepage URL
hokencenter.hsc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
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
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 | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2016 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | 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
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 27 | Day |
Last modified on
| 2019 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026918
