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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028725
Receipt No. 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

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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
Email 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
Email miyoc.45@med.tottori-u.ac.jp

Sponsor
Institute Tottori University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032811

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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