UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038158 |
|---|---|
| Receipt number | R000043482 |
| Scientific Title | Effect on overwork time by the intervention using music |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2022/04/03 16:07:12 |
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Basic information
Public title
Effect on overwork time by the intervention using music
Acronym
Backgroud music on overwork time
Scientific Title
Effect on overwork time by the intervention using music
Scientific Title:Acronym
Backgroud music on overwork time
Region
| Japan |
Condition
Condition
overwork time
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to reduce working hours, it is necessary to change the consciousness of the individual, starting with improving the environment. As part of measures to improve the environment, music is an extremely gradual intervention, but it can also be conditioned on humans. The hypothesis was set that it would contribute to the reduction of overwork time if conditions such as the close of work depending on the type of music, encouraging home return, and enjoying life after returning home could be achieved. The purpose of this study is to prove the effect scientifically.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average overowrk hours with and without music, year-on-year comparison
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
Historical
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
Observe for the first two months, play background music at the office after 15:00 for the next two months, stop the music for two months, and then play the music for the next two months.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Be able to understand overtime hours
No noticeable increase or decrease in seasonal working hours
An office that can provide basic information about the office
Key exclusion criteria
Non
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | MASAYUKI |
| Middle name | |
| Last name | TATEMICHI |
Organization
Tokai University School of Medicine
Division name
Preventive Medicine
Zip code
259-1193
Address
143 shimokasuya isehara, Kanagawa, Japan
TEL
0493931121
tatemichi@tokai-u.jp
Public contact
Name of contact person
| 1st name | MASAYUKI |
| Middle name | |
| Last name | TATEMICHI |
Organization
Tokai University School of Medicine
Division name
Preventive Medicine
Zip code
259-1193
Address
143 shimokasuya isehara, Kanagawa, Japan
TEL
0493931121
Homepage URL
tatemichi@tokai-u.jp
Sponsor or person
Institute
USEN Corporation
Institute
Department
Personal name
Funding Source
Organization
USEN Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board for clinical research, Tokai University
Address
143 shimokasuya isehara, Kanagawa, Japan
Tel
0463941121
tokai-rinsho@ml.tokai-u.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
| 2019 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/eohp/3/1/3_2021-0005-OA/_article/-char/en?msclkid=27a1cf47b3191
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/eohp/3/1/3_2021-0005-OA/_article/-char/en?msclkid=27a1cf47b3191
Number of participants that the trial has enrolled
15
Results
The trend of overtime between the observation year and the previous year significantly changed in one (1/5), one (1/5), and three (3/5) offices, in patterns A, B, and C, respectively.
Results date posted
| 2022 | Year | 04 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Now manuscript is under review.
Date of the first journal publication of results
| 2021 | Year | 05 | Month | 01 | Day |
Baseline Characteristics
Free participation from IT companies
Participant flow
Free participation
Adverse events
None
Outcome measures
None
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 30 | Day |
Last modified on
| 2022 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043482
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
