UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011398 |
|---|---|
| Receipt number | 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 11:21:11 |
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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
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
kotoyuka@idac.tohoku.ac.jp
Sponsor or person
Institute
IDAC, Tohoku university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013345
