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

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 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


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

Value
https://center6.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