UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056368 |
|---|---|
| Receipt number | R000064406 |
| Scientific Title | Optimization of Flow Experience during eSports Using Functional Brain Measurements |
| Date of disclosure of the study information | 2024/12/05 |
| Last modified on | 2025/06/06 09:39:42 |
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Basic information
Public title
Optimization of Flow Experience during eSports Using Functional Brain Measurements
Acronym
OFEES
Scientific Title
Optimization of Flow Experience during eSports Using Functional Brain Measurements
Scientific Title:Acronym
OFEES
Region
| Japan |
Condition
Condition
Normal Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To propose a fNIRS testing protocol that can objectively quantify flow experience from the perspective of developing healthy e-sports and countermeasures against gaming disorders, and to attempt to optimize the playing time during which flow experience is sustained.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain activity, Subjective flow experience, Subjective fatigue
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Six game plays during a one-day examination to measure brain function and subjective psychological state
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Approximately 60 healthy adults between the ages of 20 and 60
Key exclusion criteria
Those who cannot give consent to participate in the research, those who have severe mental fatigue and have difficulty completing the tasks, and those who have been restricted from playing video games by a physician for reasons such as reflex epilepsy or gaming disorders.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Senichiro |
| Middle name | |
| Last name | Kikuchi |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Rehabilitation Sciences
Zip code
371-8514
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-7111
senichiro@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Senichiro |
| Middle name | |
| Last name | Kikuchi |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Rehabilitation Sciences
Zip code
371-8514
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-7111
Homepage URL
senichiro@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Health Sciences
Institute
Department
Personal name
Senichiro Kikuchi
Funding Source
Organization
Japan Society for the Promotion of Science
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
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-15 Showa, Maebashi, Gunma
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
| 2024 | Year | 12 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | 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
| 2024 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064406
