UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048068 |
|---|---|
| Receipt number | R000054785 |
| Scientific Title | Examination of the relationship between music relaxation effects and music preferences |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/12/24 14:51:46 |
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Basic information
Public title
Examination of the relationship between music relaxation effects and music preferences
Acronym
Examination of the relationship between music relaxation effects and music preferences
Scientific Title
Examination of the relationship between music relaxation effects and music preferences
Scientific Title:Acronym
Examination of the relationship between music relaxation effects and music preferences
Region
| Japan |
Condition
Condition
Healthy female college student
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure how different musical tempos affect participants' relaxation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in high frequency components before and after intervention in heart rate variability analysis
Key secondary outcomes
The score of the Stress Response Scale (SRS) -18 before and after the intervention
Changes in other autonomic indicators before and after the intervention
LF / HF (sympathetic activity index)
CVRR (R-R interval fluctuation coefficient)
HR (heart rate)
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
To listen to music at different tempos
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Female college students between the ages of 18 and 25
Key exclusion criteria
Those who go to the hospital or receive treatment for mental illness
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Tani |
Organization
Tokushima University Hospital
Division name
General Medicine and Primary Care
Zip code
770-8503
Address
50 Kuramoto-cho 2, Tokushima
TEL
088-633-9656
taniken@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Harutaka |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of General Medicine
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9656
Homepage URL
yharutaka@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board of Tokushima University
Address
50 Kuramoto-cho 2, Tokushima
Tel
088-633-7958
brinshoshienk@tokushima-u.ac.jp
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
| 2022 | Year | 07 | 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
| 2022 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 10 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 15 | Day |
Last modified on
| 2022 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054785
| 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 |
