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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000034899 |
Receipt No. | R000039787 |
Scientific Title | The effects of auditory stimulation by a forest environment: A crossover test |
Date of disclosure of the study information | 2018/11/15 |
Last modified on | 2020/09/08 |
Basic information | ||
Public title | The effects of auditory stimulation by a forest environment: A crossover test | |
Acronym | The effects of auditory stimulation by a forest environment | |
Scientific Title | The effects of auditory stimulation by a forest environment: A crossover test | |
Scientific Title:Acronym | The effects of auditory stimulation by a forest environment | |
Region |
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Condition | ||
Condition | Healthy person | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | We aimed to evaluate the physiological and psychological effects of auditory stimulation by a forest environment on 20 female university students. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 1) Prefrontal activity using near-infrared spectroscopy
2) Sympathetic and parasympathetic nervous system activity as indicated by heart rate variability 3) Heart rate |
Key secondary outcomes | 1) Profile of Mood State
2) Modified semantic differential method 3) Kwansei Gakuin (KG) daily life questionnaire 4) 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 | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Auditory stimulation by a forest environment with high-resolution sound source (60 s) -> Rest time (180 s) -> No auditory stimulation condition as a control (60 s) | |
Interventions/Control_2 | No auditory stimulation condition as a control (60 s) -> Rest time (180 s) -> Auditory stimulation by a forest environment with high-resolution sound source (60 s) | |
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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | Healthy person | |||
Key exclusion criteria | 1) Subjects who are in a poor physical condition
2) Subjects who have a respiratory illness 3) Subjects who are deemed by the principle investigator as inappropriate participants for this study 4) Subjects who were menstruating on the day of the experiment 5) Subjects who had hearing impairment |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | JVCKENWOOD Victor Entertainment Corporation
Forestry and Forest Products Research Institute |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | The Ethics Committees of the Center for Environment, Health and Field Sciences, Chiba University, Japan |
Address | 6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan |
Tel | 04-7137-8010 |
field-jinji@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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 29 |
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 | Terminated | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039787 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |