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

Email

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


Email

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


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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name