UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study into the effects of music therapy on hemodialysis patients
Title of the study (Brief title)	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	Mineaki Kitamura
Organization	Nagasaki University Hospital
Division name	Division of blood purification
Address	1-7-1 Sakamoto Nagasaki Japan
TEL	095-819-7358
Email	minekitamura@nagasaki-u.ac.jp

Public contact
Name of contact person	Mineaki Kitamura
Organization	Nagasaki University Hospital
Division name	Division of blood purification
Address	1-7-1 Sakamoto Nagasaki Japan
TEL	095-819-7358
Homepage URL
Email	minekitamura@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028473