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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025074
Receipt No. R000028634
Scientific Title Efficacy assessment for care burden of remote music therapy
Date of disclosure of the study information 2016/12/10
Last modified on 2016/11/30

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Basic information
Public title Efficacy assessment for care burden of remote music therapy
Acronym Efficacy assessment of remote music therapy
Scientific Title Efficacy assessment for care burden of remote music therapy
Scientific Title:Acronym Efficacy assessment of remote music therapy
Region
Japan

Condition
Condition none
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Remote music therapy will be provided for a patient of congenital cytomegalovirus infection. The influence to the care burden of the families who are taking care of the patient will be examined.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Zarit caregiver burden scale (Japanese version)
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Patients have a music therapy session of 45 to 60 minutes for one or two times per two weeks. Intervention will last for about two months. In music therapy sessions, clients will do ensembles with small and light instruments with his/her main caregiver.
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
60 years-old >
Gender Male and Female
Key inclusion criteria applicants
Key exclusion criteria an individual who does not want to have music therapy sessions
Target sample size 2

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoko Kosugi
Organization Takasaki University of Health and Welfare
Division name Faculty of Health and Welfare, Department of Healthcare Informatics
Zip code
Address 37-1, Nakaorui-machi, Takasaki-shi, Gunma
TEL 027-352-1290
Email kosugi@takasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Kosugi
Organization Takasaki University of Health and Welfare
Division name Faculty of Health and Welfare, Department of Healthcare Informatics
Zip code
Address 37-1, Nakaorui-machi, Takasaki-shi, Gunma
TEL 027-352-1290
Homepage URL
Email kosugi@takasaki-u.ac.jp

Sponsor
Institute Takasaki University of Health and Welfare
Institute
Department

Funding Source
Organization Takasaki University of Health and Welfare
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
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
2016 Year 12 Month 10 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 No longer recruiting
Date of protocol fixation
2016 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 30 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
2016 Year 11 Month 30 Day
Last modified on
2016 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028634

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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