UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034823 |
|---|---|
| Receipt number | R000039713 |
| Scientific Title | The effects of high-resolution sound source: A crossover test |
| Date of disclosure of the study information | 2018/11/08 |
| Last modified on | 2022/07/08 23:24:18 |
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Basic information
Public title
The effects of high-resolution sound source: A crossover test
Acronym
The effects of high-resolution sound source
Scientific Title
The effects of high-resolution sound source: A crossover test
Scientific Title:Acronym
The effects of high-resolution sound source
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate the physiological and psychological effects of a high-resolution sound source 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
| Other |
Interventions/Control_1
Auditory stimulation of forest with high-resolution sound source (60 s) -> Rest time (180 s) -> Auditory stimulation of forest sound with MP3 as a dummy stimulation (60 s) - > Rest time (180 s) -> Auditory stimulation of forest sound with MP3 (60 s)
Interventions/Control_2
Auditory stimulation of forest sound with MP3 (60 s) -> Rest time (180 s) -> Auditory stimulation of forest sound with MP3 as a dummy stimulation (60 s) -> Rest time (180 s) -> Auditory stimulation of forest sound 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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
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
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
Natural 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
Natural 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
JVCKENWOOD Victor Entertainment Corporation
Forestry and Forest Products Research Institute
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
| 2018 | Year | 11 | Month | 08 | 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
| 2018 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 08 | Day |
Last modified on
| 2022 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039713
