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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040078
Receipt No. 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

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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
Email 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
Email aohashi@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045702

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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