UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032850 |
|---|---|
| Receipt number | R000037447 |
| Scientific Title | The Effectiveness of Sound Distraction for Alleviation of Pain during Cannulation of Hemodialysis patients |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2019/12/04 16:12:19 |
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Basic information
Public title
The Effectiveness of Sound Distraction for Alleviation of Pain during Cannulation of Hemodialysis patients
Acronym
A study for sounds and pain during cannulation of hemodialysis patients
Scientific Title
The Effectiveness of Sound Distraction for Alleviation of Pain during Cannulation of Hemodialysis patients
Scientific Title:Acronym
A study for sounds and pain during cannulation of hemodialysis patients
Region
| Japan |
Condition
Condition
Pain during cannulation of blood access
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Several methods mitigate pains during cannulation of blood access in hemodialysis patients, however, repeated pains are still one of the most relevant problems in hemodialysis patients. Generally, music therapy improves various pains and anxieties, however, its effects on pain associated with blood access cannulation in hemodialysis patients remains unknown. Therefore, we investigate the effect of music therapy in hemodialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain visual analog scale score of the pains during cannulation of blood access
Key secondary outcomes
Blood pressure, heart rate, anxiety visual analog scale score, State-Trait Anxiety Inventory, and salivary amylase activity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Mozart Sonata for two pianos in D major K 448
Interventions/Control_2
White noise
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
Outpatients on maintenance hemodialysis
Duration of dialysis is more than six months
Patients with urgent pain during cannulation
Key exclusion criteria
Patients whose frequency of hemodialysis therapy per week is not three times
Patients whose blood access is indwelling catheter
Patients who participate in the pilot study of this study.
Patients who are not able to agree acquisition, listen to sound, input self-assessment by mobile PC, have visual impairment and paralysis, communicating difficulty, psychiatric disorder, dementia.
Target sample size
120
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
http://www.kicks-studygroup.com/
minekitamura@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Terumo Foundation for Life Sciences and ARTs
, Shinshu Public Utility Foundation for Promotion of Medical Sciences
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Healthcare epidemiology, Kyoto University, Graduate School of Medicine and Faculty of Medicine
Department of Medical Statistics, Osaka City University Graduate School of Medicine and Faculty of Medicine
Development and role of the music therapy program in Rakuwakai Healthcare System
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
長崎腎病院（長崎県）、みはま成田クリニック（千葉県）、上田腎臓クリニック（長野県）、藤井寺敬任会クリニック（大阪府）、柏友千代田クリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.kicks-studygroup.com/
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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 03 | Day |
Last modified on
| 2019 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037447
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| Registered date | File name |
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| Registered date | File name |
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