UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028234 |
|---|---|
| Receipt number | R000032316 |
| Scientific Title | Effect of horticultural therapy on patients with depression |
| Date of disclosure of the study information | 2017/07/14 |
| Last modified on | 2025/11/04 14:39:50 |
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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 | Yoshifumi |
| Middle name | |
| Last name | Miyazaki |
Organization
Center for Environment, Health and Field Sciences, Chiba University
Division name
Nature Therapy Laboratory
Zip code
277-0882
Address
6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL
04-7137-8113
ymiyazaki@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Miyazaki |
Organization
Center for Environment, Health and Field Sciences, Chiba University
Division name
Nature Therapy Laboratory
Zip code
277-0882
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
ymiyazaki@faculty.chiba-u.jp
Sponsor or person
Institute
Center for Environment, Health and Field Sciences, Chiba University
Institute
Department
Personal name
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
The Ethics Committee of the Center for Environment, Health and Field Sciences, Chiba University
Address
6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
Tel
04-7137-8010
field-rinri@chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
https://doi.org/10.3389/fenvh.2025.1601838
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3389/fenvh.2025.1601838
Number of participants that the trial has enrolled
28
Results
Results indicated that biotope viewing significantly increased parasympathetic nervous activity while decreasing sympathetic nervous activity. Subjectively, participants reported increased comfort, relaxation, and naturalness. POMS 2 assessments further revealed a significant reduction in negative affect scores and an increase in positive affect scores.
Results date posted
| 2025 | Year | 11 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Conducted in an urban clinical setting, this crossover study involved 28 adult male outpatients with major depressive disorder.
Participant flow
This study included adult male patients with depression who were treated at the Nozaki Clinic. The inclusion criteria were as follows: individuals without chronic rhinitis or asthma, those without irregular heartbeats, and those who did not smoke.
The number of expected participants was set at 32. In total, 32 participants were initially recruited. However, four who were absent or returned home during the measurement due to illness or other reasons were excluded. Ultimately, 28 participants joined the study.
Adverse events
None
Outcome measures
Primary outcomes: Heart rate variability
Key secondary outcomes: Modified semantic differential method, Profile of Mood State
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
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
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032316
