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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023686
Receipt No. R000027280
Scientific Title The Anti-fatigue Effect of Environmental Music Evaluated by Subjective Feeling and Autonomic Nerve Activity
Date of disclosure of the study information 2016/12/01
Last modified on 2016/08/19

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Basic information
Public title The Anti-fatigue Effect of Environmental Music Evaluated by Subjective Feeling and Autonomic Nerve Activity
Acronym The Anti-fatigue Effect of Environmental Music
Scientific Title The Anti-fatigue Effect of Environmental Music Evaluated by Subjective Feeling and Autonomic Nerve Activity
Scientific Title:Acronym The Anti-fatigue Effect of Environmental Music
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the anti-fatigue effect on environmental music.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective feelings measured by the KOKORO scale.
Key secondary outcomes Autonomic function

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 No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Listening to environmental music for 30 minutes.
Interventions/Control_2 Listening to silence for 30 minutes.
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
25 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria 1. Healthy persons who are aged from 25 to 49 years.
2. Persons who want to relieve daily fatigue.
3. Persons who want to add relaxation music in daily life.
4. Persons who can participate in this trial after daily working six times.
Key exclusion criteria 1. Persons who have no experience and no interested in music.
2. Persons who have hearing disorder.
3. Persons who have medical history of neurological disease such as unconsciousness, coma, convulsion, etc.
4. Persons who are judged not suitable to participate in this trial by investigators.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyoshi Watanabe
Organization Osaka City University
Division name Center for Health Science Innovation
Zip code
Address 9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL +81-6-6485-0288
Email chsi-b@ado.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosky Kataoka
Organization Osaka City University
Division name Center for Health Science Innovation
Zip code
Address 9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL +81-6-6485-0288
Homepage URL
Email chsi-b@ado.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Center for Health Science Innovation
Institute
Department

Funding Source
Organization Della Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 大阪市立大学健康科学イノベーションセンター(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 01 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
2014 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 28 Day
Last follow-up date
2015 Year 01 Month 22 Day
Date of closure to data entry
2015 Year 01 Month 27 Day
Date trial data considered complete
2015 Year 01 Month 27 Day
Date analysis concluded
2016 Year 08 Month 15 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 19 Day
Last modified on
2016 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027280

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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