UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019409 |
|---|---|
| Receipt number | R000022448 |
| Scientific Title | Relationship of laughter with mood/emotion and cortisol and dehydroepiandrosterone (DHEA) secretion: intervention study |
| Date of disclosure of the study information | 2015/10/28 |
| Last modified on | 2018/04/21 10:15:45 |
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Basic information
Public title
Relationship of laughter with mood/emotion and cortisol and dehydroepiandrosterone (DHEA) secretion: intervention study
Acronym
Laughter, mood/emotion, and cortisol/DHEA
Scientific Title
Relationship of laughter with mood/emotion and cortisol and dehydroepiandrosterone (DHEA) secretion: intervention study
Scientific Title:Acronym
Laughter, mood/emotion, and cortisol/DHEA
Region
| Japan |
Condition
Condition
N/A (healthy people)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether spontaneous and simulated laughter alters mood/emotion and secretion of cortisol and DHEA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mood/emotion (tension, depression, anger, vitality, fatigue, and confusion) and salivary cortisol and DHEA right before, right after, and 30 minutes after the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Spontaneous laughter: watching a comedy movie "The Dictator" for the first 40 minutes, a single-time exposure in a day, not repetitive.
Interventions/Control_2
Simulated laughter: laughter yoga, a 40-minute practice, a single-time exposure in a day, not repetitive.
Interventions/Control_3
Reading books on food safety an English language (control group): for consective 40 minutes, a single-time exposure in a day, not repetitive.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
3rd-year medical student of Fujita Health University School of Medicine
Key exclusion criteria
1. Pregnancy
2. Taking medicine that could affects cortisol/DHEA secretion, such as estrogen, oral contraceptive, antipsychotic, and antidepressant
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuhiko Ota |
Organization
Fujita Health University School of Medicine
Division name
Department of Public Health
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2453
ohtaa@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuhiko Ota |
Organization
Fujita Health University School of Medicine
Division name
Department of Public Healt
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2453
Homepage URL
ohtaa@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Public Health, Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
藤田保健衛生大学医学部（愛知県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.ctcp.2018.04.005
Number of participants that the trial has enrolled
Results
Fujisawa A, Ota A, Matsunaga M, Li Y, Kakizaki M, Naito H, Yatsuya H. Effect of laughter yoga on salivary cortisol and dehydroepiandrosterone among healthy university students: A randomized controlled trial. Complementary Therapies in Clinical Practice 2018 (in press)
Objective: To examine whether laughter yoga (LY), i.e., simulated laughter, alters cortisol and dehydroepiandrosterone (DHEA) levels and cortisol/DHEA (C/D) ratios.
Methods: In a randomized controlled trial, 120 healthy university students were allocated to experiencing LY, watching a comedy movie (spontaneous laughter), or reading a book. Salivary cortisol and DHEA levels were measured immediately before, immediately after, and 30？min after the intervention.
Results: Cortisol levels and C/D ratios significantly decreased by time in the LY and comedy movie groups. Significant group*time interactions were found between these two groups for cortisol levels and C/D ratios. DHEA levels did not change by time in the LY group.
Conclusions: LY decreased cortisol levels and C/D ratios but did not affect DHEA levels. Simulated and spontaneous laughter differently affected the dynamics of cortisol levels and C/D ratios. Effect of spontaneous laughter on the cortisol dynamics lasted longer than that of simulated laughter.
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
Main results already published
Date of protocol fixation
| 2015 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 17 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 17 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 19 | Day |
Last modified on
| 2018 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022448
