UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Empirical study of the horticultural therapy as a means of the local community reproduction support in a disaster area
Title of the study (Brief title)	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	Ryuta Kawashima
Organization	IDAC, Tohoku University
Division name	Advanced Brain Science
Address	4-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7988
Email	fbi@idac.tohoku.ac.jp

Public contact
Name of contact person	Yuka Kotozaki
Organization	IDAC, Tohoku university
Division name	Advanced Brain Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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