UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028725 |
|---|---|
| Receipt number | R000032811 |
| Scientific Title | Application and validation of restorative yoga for occupational stress in night-shift female nurse by randomized crossover trial |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2018/02/19 08:59:52 |
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Basic information
Public title
Application and validation of restorative yoga for occupational stress in night-shift female nurse by randomized crossover trial
Acronym
Application and validation of restorative yoga for occupational stress in night-shift female nurse by randomized crossover trial
Scientific Title
Application and validation of restorative yoga for occupational stress in night-shift female nurse by randomized crossover trial
Scientific Title:Acronym
Application and validation of restorative yoga for occupational stress in night-shift female nurse by randomized crossover trial
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify application and validation of restorative yoga for occupational stress in night-shift female nurse by randomized crossover trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Brief Job Stress Questionnaire of Ministry of Health, Labor and Welfare
Survey time
1)Before restorative Yoga lesson
2)After restorative Yoga lesson
3)After restorative yoga for 4 weeks
4)Before conventional stress coping method
5)After conventional stress coping method for 4 week
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Restorative Yoga therapy for 4 weeks
Interventions/Control_2
Conventional stress coping method for 4 weeks
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Nurse with night shift at least 16 hours a month
2)Tottori University hospital nursing department Clinical ladder level is over "Competent"
3)Women who is 20s and 30s at the time of consent acquisition
Key exclusion criteria
1)Who with bone movement disease or psychiatric disorder
2)Someone trying new relaxation methods
3)Offered who is pregnant or may get pregnant
4)Whose research director judged inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Miyoshi |
Organization
Tottori University
Division name
Faculty of Medicine
Zip code
Address
86, Nishi-cho,Yonago,Tottori,Japan
TEL
0859-38-6317
miyoc.45@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Miyoshi |
Organization
Tottori University
Division name
Faculty of Medicine
Zip code
Address
86, Nishi-cho,Yonago,Tottori,Japan
TEL
0859-38-6317
Homepage URL
miyoc.45@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
Tottori University
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
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
| 2017 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 30 | 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
| 2017 | Year | 08 | Month | 18 | Day |
Last modified on
| 2018 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032811
| 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 |
