UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Application and validation of restorative yoga for occupational stress in night-shift female nurse by randomized crossover trial
Title of the study (Brief title)	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	Yoko Miyoshi
Organization	Tottori University
Division name	Faculty of Medicine
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	Yoko Miyoshi
Organization	Tottori University
Division name	Faculty of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000032811