UMIN-CTR Clinical Trial

Basic information
Public title	Biological effects of health method with traditional wooden brass didgeridoo playing
Acronym	Biological effects of didgeridoo playing health method
Scientific Title	Biological effects of health method with traditional wooden brass didgeridoo playing
Scientific Title:Acronym	Biological effects of didgeridoo playing health method
Region	Japan

Condition
Condition	health adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Biological effects of didgeridoo playing health method
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood pressure, the pulse, investigation into feeling, saliva stress marker (amylase), autonomic nerve index by the pulse wave measurement
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Didgeridoo playing and before and after exercise
Interventions/Control_2
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	18 years-old <
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	Male and female adults have spent a normal daily life. Also including visits and regular medication due to mild lifestyle-related diseases.
Key exclusion criteria	Severe diseases such as hospitalization is required (both mentally and physically)
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takemi Otsuki
Organization	Kawasaki Medical School
Division name	Department of Hygiene
Zip code
Address	577 Matsushima, Kurashiki
TEL	086-462-1111
Email	takemi@med.kawasaki-m.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Takemi Otsuki
Organization	Kawasaki Medical School
Division name	Department of Hygiene
Zip code
Address	577 Matsushima, Kurashiki
TEL	086-462-1111
Homepage URL
Email	takemi@med.kawasaki-m.ac.jp

Sponsor
Institute	Department of Hygiene, Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 01 Day

Related information
URL releasing protocol
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	2016 Year 05 Month 25 Day
Date of IRB	2016 Year 06 Month 13 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2019 Year 06 Month 01 Day
Date of closure to data entry	2019 Year 06 Month 01 Day
Date trial data considered complete	2019 Year 06 Month 01 Day
Date analysis concluded	2020 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date	2016 Year 04 Month 14 Day
Last modified on	2019 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025261