UMIN-CTR Clinical Trial

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

N/A (healthy people)

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

ohtaa@fujita-hu.ac.jp

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

Email

ohtaa@fujita-hu.ac.jp

Institute

Department of Public Health, Fujita Health University School of Medicine

Institute

Department

Personal name

Organization

Fujita Health University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

藤田保健衛生大学医学部（愛知県）

Date of disclosure of the study information

2015

Year

10

Month

28

Day

URL releasing protocol

Publication of results

Published

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

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 related 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