UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship of laughter with mood/emotion and cortisol and dehydroepiandrosterone (DHEA) secretion: intervention study
Title of the study (Brief title)	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	Atsuhiko Ota
Organization	Fujita Health University School of Medicine
Division name	Department of Public Health
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL	0562-93-2453
Email	ohtaa@fujita-hu.ac.jp

Public contact
Name of contact person	Atsuhiko Ota
Organization	Fujita Health University School of Medicine
Division name	Department of Public Healt
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan
TEL	0562-93-2453
Homepage URL
Email	ohtaa@fujita-hu.ac.jp

Sponsor
Institute	Department of Public Health, Fujita Health University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 10 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://doi.org/10.1016/j.ctcp.2018.04.005
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022448