UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025074 |
|---|---|
| Receipt number | 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 12:27:20 |
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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
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
kosugi@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028634
