UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045402 |
|---|---|
| Receipt number | R000051807 |
| Scientific Title | The effect of an environmental sound with inaudible high-frequency band on acute social stress responses: A psychophysiological examination |
| Date of disclosure of the study information | 2021/09/11 |
| Last modified on | 2021/09/07 13:48:51 |
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Basic information
Public title
The effect of an environmental sound with inaudible high-frequency band on acute social stress responses: A psychophysiological examination
Acronym
The effect of an environmental sound with inaudible high-frequency band on acute social stress responses: A psychophysiological examination
Scientific Title
The effect of an environmental sound with inaudible high-frequency band on acute social stress responses: A psychophysiological examination
Scientific Title:Acronym
The effect of an environmental sound with inaudible high-frequency band on acute social stress responses: A psychophysiological examination
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine whether an environmental sound with high frequency band improves tolerance and enhances efficiency of recovery from social stress that experimentally induced.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
State-Trait Anxiety Inventory
Stress level by visual analogue scale
Heart rate(HR)
Heart rate variability(HRV)
Alpha-amylase in saliva
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
playing an environmental sound with high frequency band.
Interventions/Control_2
playing an environmental sound without high frequency band.
Interventions/Control_3
playing no sound
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
Male
Key inclusion criteria
Those who reports intact auditory and visual acuity could participate in this study. They are all 20's males and female is not supposed to be included in this study because cortisol would vary with menstrual cycle and it is difficult to control it.
Key exclusion criteria
We set exclusion criteria as follows.
1. Those who would not follow our infection prevention.
2. Those who have been COVID positive or have COVID positive housemate within 2 weeks.
3. Those who go to the hospital or take medication for the purpose of treating illnesses and injuries other than allergies.
4. Those who have or have a history of mental illness or cranial nerve illness.
5. Those who have heart / circulatory system (myocardial infarction, angina, aortic aneurysm, etc.), hyperglycemia, hypertension (or similar, upper blood pressure is 140 mmHg or higher, lower blood pressure is 90 mmHg or higher) or have a history of those.
6. Those who have or have a history of respiratory system (asthma, etc.)
7. Those who have or have f a history of digestive system (hepatitis, etc.)
8. Those who have been pointed out to have depression, hypertension, hyperglycemia, or abnormal electrocardiogram in a medical examination or a hospital examination.
9. Those who smoke habitually.
10. Those who take drugs habitually.
11. Those who consume excessive alcohol.
12. Those who are taking excessive caffeine.
13. Those who are claustrophobic or who may experience strong anxiety or fear in tight or dark spaces.
14. Those who have bleeding wounds / inflammation, blisters, or blisters on the chest or abdomen.
15. Those who are excessively obese or lean.
16. Those with diabetes, coronary heart disease, cancer, or chronic obstructive pulmonary disease.
17. Those who have a profession that involves night shifts.
18. Those who are in poor health, those who are physically unhealthy.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Moriya |
Organization
Centan Inc.
Division name
Research and Development
Zip code
108-0075
Address
11F, Shinagawa East One Tower, 2-16-1, Konan, Minato city, Tokyo
TEL
03-6670-6722
moriya@centan.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Moriya |
Organization
Centan Inc.
Division name
Research and Development
Zip code
108-0075
Address
11F, Shinagawa East One Tower, 2-16-1, Konan, Minato city, Tokyo
TEL
03-6670-6722
Homepage URL
moriya@centan.jp
Sponsor or person
Institute
Centan Inc.
Institute
Department
Personal name
Funding Source
Organization
MIRISE Technologies
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Public Health Research Foundation
Address
1-1-7, Nishi-Waseda, Shinjyuku city, Tokyo
Tel
03-5287-5070
rinri@phrf.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
| 2021 | Year | 09 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2021 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051807
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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