UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025562 |
|---|---|
| Receipt number | R000029419 |
| Scientific Title | A cross over trial regarding stress management effects with high resolution sound in healthy subjects. |
| Date of disclosure of the study information | 2017/01/30 |
| Last modified on | 2017/10/30 10:37:52 |
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Basic information
Public title
A cross over trial regarding stress management effects with high resolution sound in healthy subjects.
Acronym
Evaluation of the stress management effects with high resolution sound.
Scientific Title
A cross over trial regarding stress management effects with high resolution sound in healthy subjects.
Scientific Title:Acronym
Evaluation of the stress management effects with high resolution sound.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the stress relieving effects of natural environmental sound using the audio supported high resolution sound.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Salivary amylase, cortisol, chromogranin A, IgA
Transepidermal water loss (TWEL)
Key secondary outcomes
Grade of Uchida-Kraepelin psychodiagnostic test
Questionnaire (Profile of Mood status; POMS, Japanese UWIST mood adjective checklist; JUMACL)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention 1
After informed consent, evaluations were performed. Then, subjects were required to perform Uchida-Kraepelin psychodiagnostic test for 30 min. while listening natural sound.
After intervention, evaluations were performed again.
Interventions/Control_2
Intervention 2
Before intervention, evaluations were performed. Then, subjects were required to perform Uchida-Kraepelin psychodiagnostic test for 30 min. while listening natural sound using audio supported high resolution sound.
After intervention, evaluations were performed again.
Interventions/Control_3
Intervention 3
Before intervention, evaluations were performed. Then, subjects were required to perform Uchida-Kraepelin psychodiagnostic test for 30 min.in silent space.
After intervention, evaluations were performed again.
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Subjects more than 18 years old and less than 50 years old.
2.Subjects without receiving medication.
3.Subjects who has hearing ability which everyday lives are not affected seriously.
4) Non smokers
5) Subjects without oral disease
6) Subjects who has the ability to read, wright and easy calculation.
7) subjects who have no medical history of mental illness
8) Subjects without food allergies
9) Subjects who are obtained with the prior written consent.
Key exclusion criteria
Subjects who does not fall under the inclusion criteria.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ohno |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Integrative Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
0668793498
ohno@cam.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asuka Yasueda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Integrative Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
0668793498
Homepage URL
a-yasueda@cam.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Department of Integrative Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Senri Kinran University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 01 | Month | 30 | 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
| 2017 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 06 | Day |
Last modified on
| 2017 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029419
