UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy assessment for care burden of remote music therapy
Title of the study (Brief title)	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	Naoko Kosugi
Organization	Takasaki University of Health and Welfare
Division name	Faculty of Health and Welfare, Department of Healthcare Informatics
Address	37-1, Nakaorui-machi, Takasaki-shi, Gunma
TEL	027-352-1290
Email	kosugi@takasaki-u.ac.jp

Public contact
Name of contact person	Naoko Kosugi
Organization	Takasaki University of Health and Welfare
Division name	Faculty of Health and Welfare, Department of Healthcare Informatics
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 07 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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