UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032850
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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 http://www.kicks-studygroup.com/
Email minekitamura@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037447

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.