UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040078 |
|---|---|
| Receipt number | R000045702 |
| Scientific Title | Enhanced relaxation effect of music therapy with Artificial Reality: a study of reliability and validity |
| Date of disclosure of the study information | 2020/04/06 |
| Last modified on | 2020/06/10 18:45:47 |
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Basic information
Public title
Enhanced relaxation effect of music therapy with Artificial Reality: a study of reliability and validity
Acronym
Enhanced relaxation effect of music therapy with Artificial Reality
Scientific Title
Enhanced relaxation effect of music therapy with Artificial Reality: a study of reliability and validity
Scientific Title:Acronym
Enhanced relaxation effect of music therapy with Artificial Reality
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Demonstrate healing effects by providing medical students with artificial reality and music
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
State Trait Anxiety Inventory STAI
Key secondary outcomes
level of cortisol in saliva
level of amylase in saliva
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Mindfulness program
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. healthy adults
2. Anyone with a medical condition needs permission from your doctor
Key exclusion criteria
1. Being treated for a psychiatric disorder
2. Those who were judged inappropriate by a researcher in this study for some other reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Aitsush |
| Middle name | |
| Last name | Ohashi |
Organization
Fujita Health University
Division name
School of Medical Sciences Department of Clinical Engineering Technology
Zip code
470-1192
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake, Aichi 470-1192,JAPAN
TEL
0562-93-9250
aohashi@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Aitsush |
| Middle name | |
| Last name | Ohashi |
Organization
Fujita Health University
Division name
School of Medical Sciences Department of Clinical Engineering Technology
Zip code
470-1192
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake, Aichi 470-1192,JAPAN
TEL
0562-93-2614
Homepage URL
aohashi@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
The ethics committee of Fujita Health University.
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake, Aichi 470-1192,JAPAN
Tel
0562-93-2865
r-irb@fujita-hu.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
藤田医科大学
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 06 | 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
| 2020 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 06 | Day |
Last modified on
| 2020 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045702
