UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059970 |
|---|---|
| Receipt number | R000068592 |
| Scientific Title | The effects of gamification-based psychosocial prevention overseas programs on Japanese |
| Date of disclosure of the study information | 2025/12/04 |
| Last modified on | 2025/12/04 13:04:17 |
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Basic information
Public title
The effects of gamification-based psychosocial prevention overseas programs on Japanese
Acronym
The effects of gamification-based psychosocial prevention overseas programs on Japanese
Scientific Title
The effects of gamification-based psychosocial prevention overseas programs on Japanese
Scientific Title:Acronym
The effects of gamification-based psychosocial prevention overseas programs on Japanese
Region
| Japan |
Condition
Condition
Mental Health
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the individual effects of a new French-made health solution that uses gamification to improve work engagement on Japanese people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Main Outcome: Work Engagement; Work-Related Survey (UWES).
Assessment Period: 1, 3, 6, and 12 months later.
Analysis and Statistical Methods: t-test, analysis of variance (ANOVA), Kendall's Tau Correlation Test.
Key secondary outcomes
Secondary Outcome: Presenteeism, Absenteeism
Instead of the Brief Job Stress Questionnaire (BJSQ) and the Job Crafting questionnaire used in the paper, the HPQ short form was used to assess presenteeism and absenteeism.
Demographic variables: age, gender (0 = male, 1 = female), marital status (0 = married, 1 = not married + whether or not you have children and their ages), educational attainment (0 = university or higher, 1 = high school or some college), and working hours per week.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 71 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Able to fully understand Japanese.
(2) Able to fully understand and respond to the online questionnaire.
(3) Willing to complete the two-hour protocol.
Key exclusion criteria
(1) Employees on long-term leave from a collaborating institution
(2) Individuals who the researcher determines are unable to complete the two-hour program.
Target sample size
108
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Morimatsu |
Organization
Kurume University School of Medicine
Division name
Department of Environmental Medicine
Zip code
830-0011
Address
67, Asahi-machi, Kurume
TEL
0942-31-7552
yoshitaka_morimatsu@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Morimatsu |
Organization
Kurume University School of Medicine
Division name
Department of Environmental Medicine
Zip code
830-0011
Address
67, Asahi-machi, Kurume
TEL
0942-31-7552
Homepage URL
yoshitaka_morimatsu@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Kurume University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center
Address
67, Asahi-machi, Kurume
Tel
0942-65-3749
i_rinri@kurume-u.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
| 2025 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
One, three, six, and 12 months after the program, participants will complete a questionnaire, the Brief Job Stress Questionnaire, the HPQ Short Form, and a work-related survey (UWES). Once all participants from a facility have completed the program, the results of Science Decision's analysis will be fed back to the facility. Participants will also be asked to submit the results of their stress checks for the relevant year, which will also be compared before and after participation in the program.
Management information
Registered date
| 2025 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068592
