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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025562
Receipt No. 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

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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
Email 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
Email a-yasueda@cam.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine, Department of Integrative Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029419

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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