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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024754
Receipt No. R000028473
Scientific Title A pilot study into the effects of music therapy on hemodialysis patients
Date of disclosure of the study information 2016/11/08
Last modified on 2017/05/22

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Basic information
Public title A pilot study into the effects of music therapy on hemodialysis patients
Acronym A pilot study into the effects of music therapy on hemodialysis patients
Scientific Title A pilot study into the effects of music therapy on hemodialysis patients
Scientific Title:Acronym A pilot study into the effects of music therapy on hemodialysis patients
Region
Japan

Condition
Condition patients on maintenance hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Testing the effect of music therapy on puncture pain in hemodialysis patients
Basic objectives2 Others
Basic objectives -Others Testing the effect of music therapy on anxiety in hemodialysis patients
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes puncuture pain (VAS score)
Key secondary outcomes blood pressure, heart rate before and after puncture
anxiety (VAS score, STAI)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Mozart musical pieces/ radio NEWS
Interventions/Control_2 Duration: One Week three times
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 VAS score of puncture pain is more than 30mm
Key exclusion criteria patients with psychiatric disorder, visual disturbance, hearing disorder
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mineaki Kitamura
Organization Nagasaki University Hospital
Division name Division of blood purification
Zip code
Address 1-7-1 Sakamoto Nagasaki Japan
TEL 095-819-7358
Email minekitamura@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mineaki Kitamura
Organization Nagasaki University Hospital
Division name Division of blood purification
Zip code
Address 1-7-1 Sakamoto Nagasaki Japan
TEL 095-819-7358
Homepage URL
Email minekitamura@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Nagasaki University Hospital
Organization
Division
Category of Funding Organization Self funding
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 11 Month 08 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
The difference of mean visual analogue scal in puncture pain was 4.9 mm between the music group and NEWS group. And standard deviation was 12.4 mm. From these results, the participants of the next trial will be needed 95 patients. alpha=0.05 1-beta=0.80.
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 Completed
Date of protocol fixation
2016 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 15 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 08 Day
Last modified on
2017 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028473

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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