UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023686 |
|---|---|
| Receipt number | 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 12:11:45 |
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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
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
chsi-b@ado.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Center for Health Science Innovation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027280
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
