UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047164 |
|---|---|
| Receipt number | R000053800 |
| Scientific Title | The effects of laughter and other positive psychological interventions on the prevention of the onset and severity of lifestyle-related diseases. |
| Date of disclosure of the study information | 2022/03/20 |
| Last modified on | 2022/03/13 22:50:09 |
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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
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
teoohira@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053800
