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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032603
Receipt No. R000037141
Scientific Title the effect of music therapy on serum IL-6 levels in patient with rheumatoid arthritis.
Date of disclosure of the study information 2018/05/16
Last modified on 2018/05/15

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Basic information
Public title the effect of music therapy on serum IL-6 levels in patient with rheumatoid arthritis.
Acronym the effect of music therapy on serum IL-6 levels in patient with rheumatoid arthritis.
Scientific Title the effect of music therapy on serum IL-6 levels in patient with rheumatoid arthritis.
Scientific Title:Acronym the effect of music therapy on serum IL-6 levels in patient with rheumatoid arthritis.
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the effect of music therapy by measuring serum cytokines before and after the music therapy in patients with rheumatoid arthritis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Various cytokines including serum IL-6 measured before and after music therapy
Key secondary outcomes CRP, RF, MMP 3, DAS 28 - CRP, questionnaire (pain VAS, general health VAS, doctor VAS, HADS, HAQ, SF - 8) before and after music therapy

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 music therapy
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
60 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patient with rheumatoid arthritis
Key exclusion criteria Patient without rheumatoid arthritis
Target sample size 17

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujita Shinichiro
Organization Kurashiki sweet hospital
Division name Department of rihabiritation
Zip code
Address 3542-1 Nakasho Kurashiki Okayama Japan
TEL 086-463-7111
Email sfujita@wakokai.com

Public contact
Name of contact person
1st name
Middle name
Last name Fujita shinichiro
Organization Kurashiki sweet hospital
Division name Department of rihabiritation
Zip code
Address Nakasho Kurashiki Okayma japan
TEL 086-463-7111
Homepage URL
Email sfujita@wakokai.com

Sponsor
Institute Kurashiki sweet hospital
Institute
Department

Funding Source
Organization Okayama 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
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
2018 Year 05 Month 16 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
2018 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 03 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
2018 Year 05 Month 15 Day
Last modified on
2018 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037141

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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