UMIN-CTR Clinical Trial

Basic information
Public title	The effects of laughter and other positive psychological interventions on the prevention of the onset and severity of lifestyle-related diseases.
Acronym	The effects of laughter interventions on the prevention of the onset and severity of lifestyle-related diseases.
Scientific Title	The effects of laughter and other positive psychological interventions on the prevention of the onset and severity of lifestyle-related diseases.
Scientific Title:Acronym	The effects of laughter interventions on the prevention of the onset and severity of lifestyle-related diseases.
Region	Japan

Condition
Condition	Diabetes Mellitus
Classification by specialty	Medicine in general Endocrinology and Metabolism Psychosomatic Internal Medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether laughter is useful in controlling blood glucose levels and preventing future complications by improving cardiovascular risk factors such as high blood pressure by having people with diabetes laugh regularly and increasing opportunities to laugh in their daily lives.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hemoglobin A1c level by blood test after 12-weeks intervention
Key secondary outcomes	After 12-weeks intervention (1) frequency of laughter, psychological health such as depressive symptoms and subjective stress, and lifestyle habits such as sleep time (2) Blood pressure, pulse rate, body weight, body mass index, and waist circumstance (3) Autonomic nervous system function

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
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

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes with HbA1c (NGSP criteria) of 6.1% to 7.9% within the past 3 months, and with a 3-month fluctuation of 1.0 or less.
Key exclusion criteria	Those with a history of stroke or ischemic heart disease in the past (but may participate if symptoms are stable and doctor's approval is given for light exercise).
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Tetsuya Middle name Last name Ohria
Organization	Fukushima Medical University School of Medicine
Division name	Department of Epidemiology
Zip code	960-1295
Address	Hikarigaoka 1, Fukushima-shi 960-1295
TEL	024-547-1343
Email	teoohira@fmu.ac.jp

Public contact
Name of contact person	1st name Tetsuya Middle name Last name Ohira
Organization	Fukushima Medical University School of Medicine
Division name	Department of Epidemiology
Zip code	960-1295
Address	Hikarigaoka 1, Fukushima-shi 960-1295
TEL	024-547-1343
Homepage URL
Email	teoohira@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 20 Day

Related information
URL releasing protocol	https://www.fmu.ac.jp/home/epi/report/index.html
Publication of results	Partially published

Result
URL related to results and publications	https://www.fmu.ac.jp/home/epi/report/index.html
Number of participants that the trial has enrolled	42
Results	Among 42 participants, 40 participants were included in the analysis (laughter yoga group; n=20, control group; n=20). The mean HbA1c level changed from 7.12% to 6.86% in the laughter yoga group and from 7.20% to 7.27% in the control group (mean between-group difference for change of -0.33%, P= 0.008). Positive affect increased significantly only in the laughter yoga group. Sleep duration also increased, however statistically insignificant (P = 0.074), only in the laughter yoga group.
Results date posted	2022 Year 03 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The majority of the participants were women (66.7%). There were no significant differences in baseline characteristics between the two groups.
Participant flow	42 were received baseline measurements and accepted to participate the study. Of these, 21 participants were allocated to the laughter yoga group and 21 participants to the control group. One person in the laughter yoga group and one person in the control group dropped out because of personal reasons. Finally, 40 participants were included in the analysis (20 in the laughter yoga group and 20 in the control group). Participants in both groups showed adherence rates of 95%.
Adverse events	None
Outcome measures	The mean HbA1c level changed from 7.12% to 6.86% in the laughter yoga group (P=0.004) and from 7.20% to 7.27% in the control group (P=0.410). The unadjusted difference between the two groups was statistically significant (-0.33%, 95%CI: -0.57% to -0.09%, P=0.008). Age and BMI adjusted difference was also significant (P = 0.004). The score in positive affect significantly increased only in the laughter yoga group (P = 0.018), although the between-group difference was not statistically significant. Although the statistical significance was borderline (P=0.074), there was an increase in sleep duration in the laughter yoga group, and the unadjusted and adjusted statistical significance between the laughter yoga group and the control group was also borderline (P=0.080 and 0.053, respectively).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 04 Month 01 Day
Date of IRB	2014 Year 06 Month 17 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 13 Day
Last modified on	2022 Year 03 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053800