UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024754 |
|---|---|
| Receipt number | 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 11:47:00 |
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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
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
minekitamura@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028473
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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