UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052083 |
|---|---|
| Receipt number | R000058775 |
| Scientific Title | Effects of Laughter Yoga on Mind and Body under Mental Work Stress ~ Comparison with Behavior Without Laughing |
| Date of disclosure of the study information | 2023/09/05 |
| Last modified on | 2025/03/03 09:50:59 |
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Basic information
Public title
Effects of Laughter Yoga on Mind and Body under Mental Work Stress ~ Comparison with Behavior Without Laughing
Acronym
Effects of Laughter Yoga on Mind and Body under Mental Work Stress ~ Comparison with Behavior Without Laughing
Scientific Title
Effects of Laughter Yoga on Mind and Body under Mental Work Stress ~ Comparison with Behavior Without Laughing
Scientific Title:Acronym
Effects of Laughter Yoga on Mind and Body under Mental Work Stress ~ Comparison with Behavior Without Laughing
Region
| Japan |
Condition
Condition
Healthy university students and equivalents
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of one session laughter yoga under mental stress are compared with only non-laughing movements based on psychological, physiological, and endocrine indicators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Baseline, then laughter yoga or non-laughing movements only;POMS, heart rate variability, cortisol
Key secondary outcomes
Fatigue VAS, Resilience
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Laughter yoga and non-laughing movements under mental work stress (Kraepelin test)
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy subject
Key exclusion criteria
Healthy people without regular medication without risk of falling
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Watanabe |
Organization
Nagoya Women's University
Division name
Department of Physical Therapy Faculty of Medical Science
Zip code
467-8610
Address
3-40 Shioji-cho, Mizuho-ku, Nagoya,Aichi
TEL
+81528521111
zae00426@nifty.com
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Watanabe |
Organization
Nagoya women's University
Division name
Department of Physical Therapy Faculty of Medical Science
Zip code
467-8610
Address
3-40 Shioji-cho, Mizuho-ku, Nagoya,Aich
TEL
+81528521111
Homepage URL
zae00426@nifty.com
Sponsor or person
Institute
Nagoya women's University
Institute
Department
Personal name
Junko Watanabe
Funding Source
Organization
Nagoya women's University
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
Nagoya women's University
Address
3-40
Tel
0528521111
zae00426@nifty.com
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
名古屋女子大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 05 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 01 | Day |
Last modified on
| 2025 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058775
