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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011398
Receipt No. R000013345
Scientific Title Empirical study of the horticultural therapy as a means of the local community reproduction support in a disaster area
Date of disclosure of the study information 2013/08/07
Last modified on 2018/09/30

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Basic information
Public title Empirical study of the horticultural therapy as a means of the local community reproduction support in a disaster area
Acronym Local community horticulture intervention
Scientific Title Empirical study of the horticultural therapy as a means of the local community reproduction support in a disaster area
Scientific Title:Acronym Local community horticulture intervention
Region
Japan

Condition
Condition normal
Classification by specialty
Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effect of the horticultural therapy as a means of local community reproduction support of a disaster area.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of the psychological index before and behind intervention and a saliva stress marker
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control No treatment
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 The intervention group participate in horticultural intervention program in 3 months.
Interventions/Control_2 The control group does not participate in the intervention in 3 months.
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
6 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria -Right handed
-Healthy
-Those who live in an area along the shore at the time of the occurrence of an East Japan great earthquake, and live in the makeshift house location region and the disaster public housing location region including the present deemed temporary construction
Key exclusion criteria -Those who do not live in an area along the shore in case of the East Japan great earthquake
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuta Kawashima
Organization IDAC, Tohoku University
Division name Advanced Brain Science
Zip code
Address 4-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7988
Email fbi@idac.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuka Kotozaki
Organization IDAC, Tohoku university
Division name Advanced Brain Science
Zip code
Address 4-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7988
Homepage URL
Email kotoyuka@idac.tohoku.ac.jp

Sponsor
Institute IDAC, Tohoku university
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization
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
2013 Year 08 Month 07 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
2013 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 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
2013 Year 08 Month 07 Day
Last modified on
2018 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013345

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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