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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037447