UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000037447