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Clinical observation study of the game user panel survey

Status Approved

  • First Submitted Date

    2018/10/01

  • Registered Date

    2018/12/21

  • Last Updated Date

    2018/11/13

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003398
    Unique Protocol ID C2014149
    Public/Brief Title Clinical observation study of the game user panel survey
    Scientific Title Clinical observation study of the game user panel survey
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number C2014149
    Approval Date 2014-09-12
    Institutional Review Board Name Chung-ang university hospital Institutional Review Board
    Institutional Review Board Address 102, Heukseok-ro, Dongjak-gu, Seoul
    Institutional Review Board Telephone 02-6299-2738
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Doug Hyun Han
    Title Professor
    Telephone +82-2-6299-1508
    Affiliation Chung-Ang Univerisity Hospital
    Address 102, Heukseok-ro, Dongjak-gu, Seoul
    Contact Person for Public Queries
    Name Doug Hyun Han
    Title Professor
    Telephone +82-2-6299-1508
    Affiliation Chung-Ang Univerisity Hospital
    Address 102, Heukseok-ro, Dongjak-gu, Seoul
    Contact Person for Updating Information
    Name Wonshik Seong
    Title Resident
    Telephone +82-2-6299-1508
    Affiliation Chung-Ang Univerisity Hospital
    Address 102, Heukseok-ro, Dongjak-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2014-09-12 Actual
    Target Number of Participant 100
    Primary Completion Date
    Study Completion Date 2019-03-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Chung-Ang Univerisity Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2014-09-12 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korea Creative Content Agency
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chung-Ang Univerisity Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    1) Purpose of the study
    The purpose of this study is to compare and analyze the results of clinical and normal controls through various social and brain medical tests to identify the overall causal relationship of excessive game use for teenagers who are the main targets for game use. 
    2) Background and necessity of research
    In order to discuss whether game addiction should be defined as a disease and to prepare a diagnostic standard for the disease, one needs to pay attention to the diverse characteristics of game players. Recent research suggests that problem use of games, along with individual development problems, should be considered in combination with both demographic and individual characteristics, which requires a distinct approach to general game users and problem users. The lack of reliable data necessary for game research, which is currently a problem, is due to the fragmentation of game research in various fields, such as medical, clinical psychology and social science, and thus is an integrated study that can support diverse groups. 
    Therefore, research on the factors necessary to define the use behavior of game users and the environment and psychological variables is required, including simultaneous study of physical and environmental factors such as neuropsychiatry, clinical psychology, and social science and media. In addition, it is important to analyze brain magnetic resonance imaging (fMRI) results to verify the impact of games on brain function and to identify the relationship between them by examining their neurological status and factors such as physiological examination, home environment, social capital and stress. 
    This study will buid the comparative data between excessive game use group and normal use group, identify causal attributes of clinical, environmental, and psychological variables that determine the nature of game use behavior and suggest the social science and medical convergence with a comprehensive causal connection through fMRI, clinical psychology, and social science.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 100
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    excessive game use group

    Cohort/Group Description

    In excessive game use group, middle and high school students scoring higher than 60 in Young internet addiction scale, having problems in home and school, spending 35 hours a week playing game, visiting the department of psychiatry, Chung-Ang University Hospital are targeted.
    excessive game use group every years will be conducted psychological scale test and fMRI at 1 year intervals.
    Cohort/
    Group 2

    Cohort/Group Label

    normal group

    Cohort/Group Description

    In normal group, middle and high school students who are not included in excessive game use group are targeted.
    Normal group will be conducted psyhological scale test and fMRI at 1 year intervals
    Biospecimen
    Collection & Archiving
    : DNA Collect & Archive: Sample with DNA
    Biospecimen Description
    blood
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    middle and high school
    Sampling Method
    In excessive game use group, middle and high school students scoring higher than 60 in Young internet addiction scale, having problems in home and school, spending 35 hours a week playing game, visiting the department of psychiatry, Chung-Ang University Hospital are targeted.
    In normal control group, middle and high school students visiting to the departmemt of pediatrics, Chung-Ang University Hospital and recruited through other advertisements are targeted.
    The study participants are extracted using non-probablity sampling method.
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F63.0)Pathological gambling 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    13Year~18Year

    Description

    In excessive game use group, middle and high school students scoring higher than 60 in Young internet addiction scale, having problems in home and school, spending 35 hours a week playing game, visiting the department of psychiatry, Chung-Ang University Hospital are targeted.
    Exclusion Criteria
    ①	Those who have had a history of psychologically diagnosed or are on drugs other than game addiction.
    ②	Those who are currently suffering from 1 axis and 2 axis mental illness, as a result of the structured interview
    ③	Those who are the intellectually challenged
    ④	Those who are diagnosed with congenital genetic disorder
    ⑤	Person with a history of acquired brain damage, such as cerebral palsy and head trauma
    ⑥     Person with developmental disabilities, including autism
    ⑦	Person with speech or learning difficulties
    ⑧	Those who don't use online (Internet) games or mobile (Mobile) games
    ⑨	Those who have family members related in the medical profession (intention, doctor, etc.), game company related position, newspaper/ broadcast/media/PR related field, consulting company, market and opinion survey company
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    Neurocognitive test (K-WISC-IV/K-WAIS-IV)
    Timepoint
    When participants agree the participate in the study, Neurocognitive test is conducted.
    Primary Outcome(s) 2
    Outcome
    psychological scale test(Comprehensive Scale for Assessing Game Behavior, CSG)
    Timepoint
    When participants agree the participate in the study, CSG is conducted. Follow-up test is conducted at one-year intervals.
    Primary Outcome(s) 3
    Outcome
    psychological scale test(Young's Internet Addiction Test, YIAS)
    Timepoint
    When participants agree the participate in the study, YIAS is conducted. Follow-up test is conducted at one-year intervals.
    Primary Outcome(s) 4
    Outcome
    fMRI
    Timepoint
    When participants agree the participate in the study, fMRI is conducted. Follow-up test is conducted at one-year intervals.
    Primary Outcome(s) 5
    Outcome
    genetic test
    Timepoint
    When participants agree the participate in the study, Neurocognitive test is conducted.
    Secondary Outcome(s) 1
    Outcome
    questions about personal game use, epidemiological survey
    Timepoint
    When participants agree the participate in the study, question and survey are conducted. Follow-up is conducted at one-year intervals
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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