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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028234
Receipt No. R000032316
Scientific Title Effect of horticultural therapy on patients with depression
Date of disclosure of the study information 2017/07/14
Last modified on 2018/01/18

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Basic information
Public title Effect of horticultural therapy on patients with depression
Acronym Effect of horticultural therapy on patients with depression
Scientific Title Effect of horticultural therapy on patients with depression
Scientific Title:Acronym Effect of horticultural therapy on patients with depression
Region
Japan

Condition
Condition Depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to clarify the effect of horticultural therapy on outpatients with depression using psychological and physiological indicators.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Heart rate variability (during 4 minutes of visual stimulation)
Key secondary outcomes 1) Profile of Mood State
2) Modified semantic differential method
3) Zung Self-rating Depression Scale
4) Kwansei Gakuin (KG) daily life questionnaire
5) Trait Anxiety of State-Trait Anxiety Inventory

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Visual stimulation through a roadside plant
Time: 4 min
Interventions/Control_2 Visual stimulation through a roadside building
Time: 4 min
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
60 years-old >=
Gender Male
Key inclusion criteria Outpatients with depression
Key exclusion criteria 1. Subjects who are in poor physical condition
2. Subjects who do not have respiratory illnesses
3. Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshifumi Miyazaki
Organization Center for Environment, Health and Field Sciences, Chiba University
Division name Nature Therapy Laboratory
Zip code
Address 6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL 04-7137-8113
Email ymiyazaki@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshifumi Miyazaki
Organization Center for Environment, Health and Field Sciences, Chiba University
Division name Nature Therapy Laboratory
Zip code
Address 6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL 04-7137-8113
Homepage URL http://www.fc.chiba-u.jp/research/miyazaki/index.html
Email ymiyazaki@faculty.chiba-u.jp

Sponsor
Institute Center for Environment, Health and Field Sciences, Chiba University
Institute
Department

Funding Source
Organization The Vehicle Racing Commemorative Foundation
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
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
2017 Year 07 Month 14 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 No longer recruiting
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 23 Day
Last follow-up date
2017 Year 07 Month 30 Day
Date of closure to data entry
2017 Year 08 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 14 Day
Last modified on
2018 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032316

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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