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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019772
Receipt No. R000022833
Scientific Title Effects of self-relaxation by "Dohsa-hou" bring to mind and body of adolescents
Date of disclosure of the study information 2015/11/13
Last modified on 2020/10/21

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Basic information
Public title Effects of self-relaxation by "Dohsa-hou" bring to mind and body of adolescents
Acronym Effects of self-relaxation by "Dohsa-hou"
Scientific Title Effects of self-relaxation by "Dohsa-hou" bring to mind and body of adolescents
Scientific Title:Acronym Effects of self-relaxation by "Dohsa-hou"
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To discuss the effectiveness of the psychological method named "Dohsa-hou" for mind and body relaxation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes State-Trait Anxiety Inventory before and after the experience of "Dohsa-hou"
Key secondary outcomes

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 1.Individual practice Plan:
Experience of "Dohsa-hou" including shoulder- relaxation task & Bending -down- forward-task
Once a week
Ten times in total

2.Group practice plan :
Experience of "Dohsa-hou"
Once a week
Two or three times in total
(1) Self-relaxation: Participants perform the task on their own.
(2) Pair-relaxation: They do it in pairs while assisting each other.
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 Physically unimpaired person
Key exclusion criteria Person with a physical disability
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Shoko
Middle name
Last name Yoshikawa
Organization Nakamura Gakuen University
Division name Faculty of Education
Zip code 814-0198
Address 5-7-1,Befu,Jonan-ku,Fukuoka, 814-0198, Japan
TEL 092-851-2531
Email yoshi@nakamura-u.ac.jp

Public contact
Name of contact person
1st name Shoko
Middle name
Last name Yoshikawa
Organization Nakamura Gakuen University
Division name Faculty of Education
Zip code 814-0198
Address 5-7-1,Befu,Jonan-ku,Fukuoka, 814-0198, Japan
TEL 092-851-2531
Homepage URL
Email yoshi@nakamura-u.ac.jp

Sponsor
Institute Shoko Yoshikawa
Institute
Department

Funding Source
Organization Nakamura Gakuen University
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nakamura Gakuen University
Address 5-7-1,Befu,Jonan-ku,Fukuoka,814-0198
Tel 092-851-2531
Email kks@nakamura-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 中村学園大学

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 13 Day

Related information
URL releasing protocol Nothing
Publication of results Unpublished

Result
URL related to results and publications ICP2016 at Yokohama Japan Poster Presentation
Number of participants that the trial has enrolled 20
Results
Dohsa-hou is the method to control their bodily movements and to improve psychological health. The STAI scale in High A-Trait group was higher than the Low group. After the Dohsa-hou sessions, the State-Anxiety score was decreased in both groups. High group showed higher scores in the sense of Difficulty of movement control and Nervous than low group. It is suggested that Dohsa-hou expected as a program for the stress management in interpersonal relations. 
Results date posted
2020 Year 10 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Students ( 20-21 years old /  7 males & 13 females 
Participant flow
?
Adverse events
Nothing
Outcome measures
 State Trait Anxiety Inventory Form JYZ consisting of two subscales.
 Questionnaire about awareness of movement
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 11 Month 13 Day
Date of IRB
2015 Year 10 Month 16 Day
Anticipated trial start date
2015 Year 11 Month 13 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 10 Month 21 Day
Date trial data considered complete
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 13 Day
Last modified on
2020 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022833

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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