UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025987 |
|---|---|
| Receipt number | R000029868 |
| Scientific Title | Effect of laughter for prevention of development or exacerbation of lifestyle diseases: Intervention study |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2017/02/03 13:38:39 |
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Basic information
Public title
Effect of laughter for prevention of development or exacerbation of lifestyle diseases: Intervention study
Acronym
Effect of laughter for prevention of lifestyle diseases: randomized controlled trial
Scientific Title
Effect of laughter for prevention of development or exacerbation of lifestyle diseases: Intervention study
Scientific Title:Acronym
Effect of laughter for prevention of lifestyle diseases: randomized controlled trial
Region
| Japan |
Condition
Condition
Lifestyle disease (metabolic syndrome, diabetes mellitus, hypertension)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of laughter on HbA1c, blood pressure, and stress markers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c (rapid determination)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Same intervention program is conducted on 0-3 month for early intervention group and 4-6 month for later intervention group. Intervention program is 90 minutes each, once a week, 10 times and the contents are as follows.
1. Small lecture about laughter and health and diabetes
2. Increasing the chance of laughter in the program of Laughter yoga and sit-down comedy
3. Increasing the chance of laughter trough communication with other participants in the program
4. Increasing the chance of laughter through introducing the event, movie, books regarding laughter.
*Laughter yoga is the combination health management methods of laughter as an exercise and breathing of yoga. People are able to experience laughter without laughable emotion. We applied laughter yoga since it is easy to practice for public.
Interventions/Control_2
Participants live as usual for another half of the research period.
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Those who live around Okayama city and able to participate in the program
2. Those who have metabolic syndrome or suspicious to have it.
3. Those who are able to do light physical activity
4. Those who understand and consent with participation to the study after the enough explanation of the study purpose and contents.
Key exclusion criteria
Those who have history of stroke or coronary heart disease (They are able to participate if primary doctor allow the participation)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eri Eguchi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Public health
Zip code
Address
Shikata cho 2-5-1
TEL
086-235-7184
eri_eguchi@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eri Eguchi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Public health
Zip code
Address
Shikata cho 2-5-1
TEL
086-235-7184
Homepage URL
eri_eguchi@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development : AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 03 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | 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
| 2017 | Year | 02 | Month | 03 | Day |
Last modified on
| 2017 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029868
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
