UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028247 |
|---|---|
| Receipt number | R000032323 |
| Scientific Title | The effect of autonomic nerve activity and cardiovascular system on Mozart's music |
| Date of disclosure of the study information | 2017/07/15 |
| Last modified on | 2017/07/14 19:01:03 |
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Basic information
Public title
The effect of autonomic nerve activity and cardiovascular system on Mozart's music
Acronym
The effect of autonomic nerve activity and cardiovascular system on Mozart's music
Scientific Title
The effect of autonomic nerve activity and cardiovascular system on Mozart's music
Scientific Title:Acronym
The effect of autonomic nerve activity and cardiovascular system on Mozart's music
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effect of cardiovascular system,
respiratory rate, and autonomic nerve activity on Mozart's music.
Basic objectives2
Others
Basic objectives -Others
We compare cardiovascular system, respiratory rate, and autonomic nerve system between before listening music and after listening music.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We investigate all participants' heart rate, respiratory rate, blood pressure, and heart rate variability in a resting state, when taking loading test, and when listening to the music.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
All participants take the reading-span-test in Japanese for ten minutes before listening to music. They take it each three times.
All participants listen to two music for about 8 minutes each.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All participants are non-smokers without any history of respiratory or cardiovascular disease. None of the participants routinely take medicine that affect on autonomic nervous regulation. All participants has no auditory disorder.
Key exclusion criteria
Participants who smoke or have any history of respiratory or cardiovascular disease. participants who take medicine that affect on autonomic nervous regulation. Participants has any auditory disorder.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoko Maruyama |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Health Sciences
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan.
TEL
022-717-7484
maruyama@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoko Maruyama |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Health Sciences
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan.
TEL
022-717-7484
Homepage URL
maruyama@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
We have no funding source
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 14 | Day |
Last modified on
| 2017 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032323
