UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039836 |
|---|---|
| Receipt number | R000045436 |
| Scientific Title | Effects of participatory workplace improvement program on stress-related biomarkers and self-reported stress among university hospital nurses |
| Date of disclosure of the study information | 2020/03/20 |
| Last modified on | 2020/03/16 21:11:53 |
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Basic information
Public title
Effects of participatory workplace improvement program on stress-related biomarkers and self-reported stress among university hospital nurses
Acronym
Effects of participatory workplace improvement program on stress-related biomarkers and self-reported stress among university hospital nurses
Scientific Title
Effects of participatory workplace improvement program on stress-related biomarkers and self-reported stress among university hospital nurses
Scientific Title:Acronym
Effects of participatory workplace improvement program on stress-related biomarkers and self-reported stress among university hospital nurses
Region
| Japan |
Condition
Condition
Occupational stress
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of a participatory workplace improvement program on stress-related biomarkers and self-reported stress among hospital nurses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pro- and anti-inflammatory markers
Key secondary outcomes
Autonomic nervous activity, perceived occupational stress
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
| Behavior,custom |
Interventions/Control_1
Participatory workplace improvement program: identification of problems at the workplace, focus group interviews (two times), action plans and implementation (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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Working at the hospital as a nurse
Key exclusion criteria
1) Being pregnant
2) Having severe illness
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Nakata |
Organization
International University of Health and Welfare
Division name
School of Medicine
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo
TEL
03-5574-3962
nakataa@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tsukumi |
| Middle name | |
| Last name | Tondokoro |
Organization
International University of Health and Welfare
Division name
School of Medicine
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo
TEL
03-5574-3962
Homepage URL
18M3013@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
International University of Health and Welfare
Address
4-1-26 Akasaka, Minato-ku, Tokyo, Japan
Tel
03-5574-3962
18M3013@g.iuhw.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
| 2020 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.dropbox.com/s/adrbwmnvn4bhqml/Final%E7%A0%94%E7%A9%B6%E8%A8%88%E7%94%BB%E6%9B%B8_%E7%9C%
Publication of results
Unpublished
Result
URL related to results and publications
https://www.dropbox.com/s/wic9fvf2k29tkbd/APA_Abstract_Tondokoro%20final.docx?dl=0
Number of participants that the trial has enrolled
36
Results
Blood inflammatory markers were significantly reduced after the intervention.
Results date posted
| 2020 | Year | 03 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Nurses working at a hospital
Participant flow
Evaluation at before, immediately after, and three months after the intervention
Adverse events
None
Outcome measures
Blood inflammatory markers, autonomic nervous activity, perceived occupational stress
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 16 | Day |
Last modified on
| 2020 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045436
