UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019772
Receipt number 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 03:20:56

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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 or person

Institute

Shoko Yoshikawa

Institute

Department

Personal name



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

Value
https://center6.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