UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054340 |
|---|---|
| Receipt number | R000062079 |
| Scientific Title | Comparison of the Effect of Nature Sound and City Sound Exposure from the Speakers on Stress Reaction: A Crossover Study |
| Date of disclosure of the study information | 2024/05/09 |
| Last modified on | 2024/05/08 21:07:08 |
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Basic information
Public title
Comparison of the Effect of Nature Sound and City Sound Exposure from the Speakers on Stress Reaction: A Crossover Study
Acronym
Comparison of the Effect of Nature Sound and City Sound Exposure from the Speakers on Stress Reaction: A Crossover Study
Scientific Title
Comparison of the Effect of Nature Sound and City Sound Exposure from the Speakers on Stress Reaction: A Crossover Study
Scientific Title:Acronym
Comparison of the Effect of Nature Sound and City Sound Exposure from the Speakers on Stress Reaction: A Crossover Study
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this crossover study is to compare the effect of nature sound and city sound exposure from the speakers on stress reaction and working efficiency.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary cortisol
Key secondary outcomes
Pulse
Profile of Mood States 2nd Edition
Uchida-Kraepelin performance test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
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
| Behavior,custom |
Interventions/Control_1
Taking the Uchida-Kraepelin performance test hearing the nature sound from the speakers.
Interventions/Control_2
Taking the Uchida-Kraepelin performance test hearing the city sound from the speakers.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 20 to below 75 years at the time of consent acquisition.
2. Subjects who can do addition.
3. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who are taking psychotropic drugs and/or anti-anxiety drugs (exception: sleeping pills are allowed except the day before the test).
2. Subjects with mental and/or heart diseases which may get worse by getting stress.
3. Subjects who cannot follow the restrictions of diets or medicines.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Koya |
| Middle name | |
| Last name | Nakashima |
Organization
Nakashima Koya Clinic
Division name
Director
Zip code
8111213
Address
2-127 Nakabaru, Nakagawa-shi, Fukuoka, 811-1213, Japan
TEL
092-954-1611
nakashimako@k9.dion.ne.jp
Public contact
Name of contact person
| 1st name | Koya |
| Middle name | |
| Last name | Nakashima |
Organization
Nakashima Koya Clinic
Division name
Director
Zip code
8111213
Address
2-127 Nakabaru, Nakagawa-shi, Fukuoka, 811-1213, Japan
TEL
092-954-1611
Homepage URL
nakashimako@k9.dion.ne.jp
Sponsor or person
Institute
Nakashima Koya Clinic
Institute
Department
Personal name
Koya Nakashima
Funding Source
Organization
Nakashima Koya Ckinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Society for Harmonic Science
Name of secondary funder(s)
Joy Fundation Co. Ltd
IRB Contact (For public release)
Organization
Tanaka Gastrointestinal Clinic Institutional Review Board
Address
8-3 Otowa-machi, Aoi-ku, Shizuoka-shi, Shizuoka, 420-0844, Japan
Tel
054-247-5522
nakashimako@k9.dion.ne.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2023-001
Org. issuing International ID_1
Tanaka Gastrointestinal Clinic Institutional Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 09 | 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
| 2023 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 05 | Month | 08 | Day |
Last modified on
| 2024 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062079
