UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A cross over trial regarding stress management effects with high resolution sound in healthy subjects.
Title of the study (Brief title)	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	Satoshi Ohno
Organization	Osaka University Graduate School of Medicine
Division name	Department of Integrative Medicine
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	0668793498
Email	ohno@cam.med.osaka-u.ac.jp

Public contact
Name of contact person	Asuka Yasueda
Organization	Osaka University Graduate School of Medicine
Division name	Department of Integrative Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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