UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028691 |
|---|---|
| Receipt number | R000032766 |
| Scientific Title | Effectiveness of occupational sleep health guidance on work engagement of workers aware of difficulty sleeping: non-randomized, single arm and time series trial |
| Date of disclosure of the study information | 2017/08/21 |
| Last modified on | 2020/11/07 00:24:38 |
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Basic information
Public title
Effectiveness of occupational sleep health guidance on work engagement of workers aware of difficulty sleeping: non-randomized, single arm and time series trial
Acronym
Effectiveness of occupational sleep health guidance on work engagement
Scientific Title
Effectiveness of occupational sleep health guidance on work engagement of workers aware of difficulty sleeping: non-randomized, single arm and time series trial
Scientific Title:Acronym
Effectiveness of occupational sleep health guidance on work engagement
Region
| Japan |
Condition
Condition
Healthy industrial population aware of sleep difficulty
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of occupational sleep health guidance for workers aware of sleep difficulty in work engagement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Work engagement will be measured by the Japanese short version of the Utrecht work engagement scale (Two months after the start of intervention)
Key secondary outcomes
1) Quality of sleep by using Pittsburgh sleep quality index, Japanese Version (Two months after the start of intervention)
2) Work performance by WHO health and work performance questionnaire (short form) Japanese edition (Two months after the start of intervention)
3) Depression by the center for epidemiologic studies depression scale (Two months after the start of intervention)
4) Support resources by analyzing usage status of support resources related to sleep (Two months after the start of intervention)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We conduct occupational sleep guidance based on cognitive behavioral therapy for insomnia, and we added the two points: assessment of symptom occurrence or exacerbation factors and viewpoint of psychosocial problem solving.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Employees of companies in Japan
2) Those who do not plan to retire within six months
3) Those who are aware of at least one insomnia symptom (difficulty falling asleep, arousal during sleep, early-morning awakening, the lack of a deep sleep feeling )
4) Those who can participate in the trial for four months including two months non-intervention period and two months intervention period, and twice 30 minutes personal interview (the first time and one month after starting)
5) Those who can consent about the study by documents.
Key exclusion criteria
1) Those who are presumed to be unable to understand and complete the purpose of this study because of their physical and mental disabilities
2) Those who the research staff judges that he/she is inappropriate for participation in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kana |
| Middle name | |
| Last name | Kazawa |
Organization
Hiroshima University
Division name
Graduate School of Biomedical & Health Sciences
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL
+81-82-257-5365
morimich@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Toyoshima |
Organization
Hiroshima University
Division name
Graduate School of Biomedical & Health Sciences
Zip code
7348553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL
+81-82-257-5367
Homepage URL
d161682@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
University Grants
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
Hiroshima University
Address
Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
Tel
+81822575367
d161682@hiroshima-u.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
| 2017 | Year | 08 | Month | 21 | 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
100
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Currently, preparing a result paper.
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
| 2017 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 16 | Day |
Last modified on
| 2020 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032766
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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