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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005364
Receipt No. R000004022
Scientific Title Reduction of stress and prevention of metabolic syndrome through music and laugh: randomized-controlled trial
Date of disclosure of the study information 2011/04/01
Last modified on 2012/04/02

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Basic information
Public title Reduction of stress and prevention of metabolic syndrome through music and laugh: randomized-controlled trial
Acronym Reduction of stress and prevention of metabolic syndrome through music and laugh: randomized-controlled trial
Scientific Title Reduction of stress and prevention of metabolic syndrome through music and laugh: randomized-controlled trial
Scientific Title:Acronym Reduction of stress and prevention of metabolic syndrome through music and laugh: randomized-controlled trial
Region
Japan

Condition
Condition normal to high blood pressure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of music and laughter on blood pressure and reduction of stress.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes blood pressure, heart rate, and coltisol
Key secondary outcomes perceived stress, lifestyle behaviors (diet, exercize, alcohol intake, sleep duration etc.) hours of listening music and laughter at home, Augmentation index, biochemical examination, peripheral blood examination, hemoglobin A1c and immunological test

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Health Education and Music Intervention
Music Intervention: Conducted mainly by two music therapists. The sessions were
composed of listening to, singing and stretching with music. Participants were also encouraged to listen to music at home.

Interventions/Control_2 Health Ecucation and Laughter Intervention
Laughter Intervention: Conducted by trained laughter yoga leaders.The sessions were composed of breathing exercises with laughter that's stimulated through playful eye contact, and watched Rakugo, Japanese traditional sit-down comedy. Participants were also encouraged to do laughter yoga at home.
Interventions/Control_3 Healhty Education Only
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria no critical disease and possible to participate intervention.
Key exclusion criteria have critical disease and impossible to participate in intervention.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Iso
Organization Osaka University Graduate School of Medicine
Division name Public Health
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3911
Email

Public contact
Name of contact person
1st name
Middle name
Last name Eri Eguchi
Organization Osaka University Graduate School of Medicine
Division name Public Health
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3911
Homepage URL
Email

Sponsor
Institute Public Health, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
2011 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 04 Month 01 Day
Last modified on
2012 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004022

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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