UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049062 |
|---|---|
| Receipt number | R000055898 |
| Scientific Title | The effects of Laughter Yoga on mental and social aspects of college students |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2023/03/31 09:50:40 |
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Basic information
Public title
The effects of Laughter Yoga on mental and social aspects of college students
Acronym
The effects of Laughter Yoga on mental and social aspects of college students
Scientific Title
The effects of Laughter Yoga on mental and social aspects of college students
Scientific Title:Acronym
The effects of Laughter Yoga on mental and social aspects of college students
Region
| Japan |
Condition
Condition
Healthy college students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of Laughter Yoga on the mental and social aspects of college students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcomes are a questionnaire on the implementation of Laughter Yoga, POMS2, and observation records during the implementation of Laughter Yoga.
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Laughter Yoga
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
| 20 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy college students
Key exclusion criteria
Excluding those who have conducted Laughter Yoga before.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Maeda |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
0338191211
k-maeda@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Maeda |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
0338191211
Homepage URL
k-maeda@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokyo Metropolitan University
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
Tel
0338191211
k-maeda@tmu.ac.jp
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
| 2022 | Year | 09 | Month | 30 | 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
10
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
| 2022 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 12 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 29 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055898
| Research Plan | |
|---|---|
| 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 |
