UMIN-CTR Clinical Trial

Public title

Effects of laughter therapy on prevention of life-style diseases incident and its complication: a randomized intervention study

Acronym

Effects of laughter therapy on life-style diseases: a randomized intervention study

Scientific Title

Effects of laughter therapy on prevention of life-style diseases incident and its complication: a randomized intervention study

Scientific Title:Acronym

Effects of laughter therapy on life-style diseases: a randomized intervention study

Region

Japan

Condition

Metabolic syndrome, hypertension, diabetes mellitus, dyslipidemia, obesity

Classification by specialty

Endocrinology and Metabolism	Psychosomatic Internal Medicine	Geriatrics
Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effects of laughter therapy on lifestyle-related diseases and thier control in this randomized intervention study

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Metabolis syndrome (Body weight, waist circumference, blood pressure, HbA1c) after 12-week intervension.

Key secondary outcomes

Autonomic nervus function, Depressive symptom, QOL, physical function, dyslipidemia, physical activity, psychological health after 12-week intervension.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Laughter Yoga (1hour, 8 times/12 weeks)

Interventions/Control_2

Lecture about laughter and health (30min, 8 times/12 weeks)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

BMI >=25kg/m2 or
Weist circumference >=85cm for men >=90cm for women or
SBP >=130mmHg or DBP >=85mmHg or
HbA1c >=5.6% or
TG >=150mg/dL or HDL cholesterol<40mg/dL
or Medication use (hypertension, diabetes mellitus, or dyslipidemia)

Key exclusion criteria

acute myocardial infarction
acute stroke

Target sample size

300

Name of lead principal investigator

1st name	Tetsuya
Middle name
Last name	Ohira

Organization

University of Fukushima School of Medicine

Division name

Department of Epidemiology

Zip code

960-1295

Address

Hikarigaoka 1, Fukushima-shi, Fukushima-ken, 960-1295 Japan

TEL

024-547-1343

Email

teoohira@fmu.ac.jp

Name of contact person

1st name	Tetsuya
Middle name
Last name	Ohira

Organization

University of Fukushima School of Medicine

Division name

Department of Epidemiology

Zip code

960-1295

Address

Hikarigaoka 1, Fukushima-shi, Fukushima-ken, 960-1295 Japan

TEL

024-547-1343

Homepage URL

Email

teoohira@fmu.ac.jp

Institute

Fukushima Medical University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Osaka University, Okayama University, Ryukyu University, Chiba University,National Hospital Organizastion Kyoto Medical Center

Name of secondary funder(s)

Organization

Ethics Review Committee, Fukushima Medical University

Address

Hikarigaoka 1, Fukushima-shi, Fukushima -ken, 960-1295 Japan

Tel

024-547-1825

Email

rs@fmu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福島県立医科大学（福島県）、岡山大学（岡山県）、大阪大学（大阪府）、琉球大学（沖縄県）

Date of disclosure of the study information

2017

Year

04

Month

27

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/icdr/ctr_menu_form_reg.cgi?recptno=R000030171

Publication of results

Partially published

URL related to results and publications

https://upload.umin.ac.jp/cgi-bin/icdr/ctr_menu_form_reg.cgi?recptno=R000030171

Number of participants that the trial has enrolled

300

Results

The comprehensive laughter program significantly improved the mean body weight (p = 0.008), BMI (p = 0.006), subjective stress (p = 0.004), subjective well-being (p = 0.002), optimism (p = 0.03), and physical component summary (PCS) scores of HRQOL (p = 0.04). A similar tendency was observed for the mean changes in BMI and subjective stress score by area, sex, and age. Moreover, there was a significant and negative correlation between the change in BMI and the change in PCS (p = 0.03).

Results date posted

2021

Year

12

Month

28

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Two hundred thirty-five participants (37 men and 198 women) aged 43 to 79 years were eligible for inclusion. These 235 participants were randomized into the laughter and control groups (n = 117 and n = 118, respectively). Additionally, 9 women and one man dropped out before the 12-week follow-up examination, because of scheduling conflicts (n = 113 and n = 112, respectively). Participants were recruited in Fukushima between 2017 and 2018, and in Osaka and Okayama in 2017, through flyers and newspaper advertisements. Participants were predominantly female (84.3%) and older than 60 years old (83.1%). There were no differences between the laughter and control groups at baseline. Of the 235 participants, 95 were in Fukushima, 62 were in Osaka, and 78 were in Okayama, and the average attendance rate was more than 88.6%.

Participant flow

Men and women ages 40 to 79 who had one or more risk factors of metabolic syndrome such as higher obesity grade, hypertension, dyslipidemia, or were taking medication for hypertension, diabetes, or cholesterol, and who lived in or near Fukushima, Fukushima Prefecture; Osaka, Osaka Prefecture; or Okayama, Okayama Prefecture, Japan, were eligible for inclusion in this study. Participants were excluded if they were under treatment for a severe cardiovascular disease or severe stroke. The studies were conducted at Fukushima Medical University in Fukushima, Osaka University in Osaka, and Okayama University in Okayama, Japan.
The studies were conducted at Fukushima Medical University in Fukushima, Osaka University in Osaka, and Okayama University in Okayama, Japan.
The laughter program was composed of an approximately 30-minute lecture, which was about laughter, health, and diseases, or an approximately 30-minute appreciation of rakugo by a professional performer of rakugo, which is a traditional form of Japanese comic storytelling, and an approximately 60-minute laughter yoga class by the laughter yoga teachers in the Japan Laughter Yoga Association. Rakugo was regarded as a part of the lecture on laughter, and two lectures were given in such a way as to make the participants laugh while teaching about laughter and health. The intervention classes with the laughter groups were conducted between June and September 2017 and between May and July 2018 in Fukushima, November 2017 and February 2018 in Osaka, and May and July 2017 in Okayama. During the waiting period, the control group went about their daily lives as usual. For the control group, the intervention classes were conducted after the control period for the same period. In addition, we asked the participants to keep a laughter diary during the intervention period to check their frequency of laughter outside the program.

Adverse events

None in particular

Outcome measures

Primary endpoints
Change in the following metabolic syndrome factors after 3 months of intervention: abdominal circumference, body weight, body fat percentage, HbA1c, blood pressure, and percentage of people with metabolic syndrome or suspected metabolic syndrome.

Secondary endpoints
Change in the following items after 3 months of intervention
Stress-related indicators (depressive symptoms, frequency of laughter, sense of well-being, subjective stress, quality of life (QOL), autonomic nervous system function)

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2016

Year

04

Month

01

Day

Date of IRB

2016

Year

05

Month

17

Day

Anticipated trial start date

2016

Year

06

Month

14

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

04

Month

26

Day

Last modified on

2022

Year

08

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030171