UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005364 |
|---|---|
| Receipt number | 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 20:14:41 |
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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
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
Sponsor or person
Institute
Public Health, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004022
