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Effect of participation in occupational activities for mental health and well being in COVID-19 patient.

Status Approved

  • First Submitted Date

    2021/10/27

  • Registered Date

    2021/11/08

  • Last Updated Date

    2023/12/11

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
    KCT0006714
    Unique Protocol ID B-2111-719-302
    Public/Brief Title Effect of occupation therapy for mental health and well being in COVID-19 patient.
    Scientific Title Effect of participation in occupational activities for mental health and well being in COVID-19 patient.
    Acronym EPOAMHWBCP
    MFDS Regulated Study No
    IND/IDE Protocol No
    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 B-2111-719-302
    Approval Date 2021-10-25
    Institutional Review Board Name Seoul National University Bundang Hospital Institutional Review Board
    Institutional Review Board Address 82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
    Institutional Review Board Telephone 031-787-8801
    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 Jin Young Ko
    Title Rehabilitation Physician
    Telephone +82-31-8046-5381
    Affiliation Seoul National University Bundang Hospital
    Address 82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
    Contact Person for Public Queries
    Name Jae Hyu Jung
    Title Occupational therapist
    Telephone +82-31-8046-5380
    Affiliation Gyeonggi Provincial Medical Center Ansung Hospital
    Address 95, Nampa-ro, Anseong-si, Gyeonggi-do, Republic of Korea
    Contact Person for Updating Information
    Name Jae Hyu Jung
    Title Occupational therapist
    Telephone +82-31-8046-5380
    Affiliation Gyeonggi Provincial Medical Center Ansung Hospital
    Address 95, Nampa-ro, Anseong-si, Gyeonggi-do, Republic of Korea
  • 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 Not yet recruiting
    Date of First Enrollment 2021-11-08 Anticipated
    Target Number of Participant 200
    Primary Completion Date 2022-11-07 , Anticipated
    Study Completion Date 2022-11-07 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Gyeonggi Provincial Medical Center Ansung Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-11-08 ,
  • 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 Seoul National University Bundang Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Seoul National University Bundang Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Patients undergoing isolation treatment following COVID-19 are known to report symptoms such as boredom, anxiety, depression and insomnia due to changes in their daily lives. In addition, previous research suggests that these mental health problems will intensify due to limitations in daily living and inefficient use of time during isolation. Accordingly, we expect that when patients with COVID-19 participated in occupational activities during the isolation period, it would have a positive effect on the quality of life and psychological on patients. Most hospitals dedicated to COVID-19do not practice work-based interventions on patients. So, the results of this study would be able to provide evidence-based interventions for positive isolation experiences of COVID-19 patients.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
     Supportive Care
    Phase Not applicable
    Intervention Model Factorial  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Behavioral  
    Intervention Description
    1. Face-to-face intervention(Participation in occupational activities)
    - Conduct on the experimental group.
    - Participate in occupational activities with an occupational therapist (face to face)
    - A list(knitting, curling books, figure making, and masterpiece puzzles etc) in which the occupations that can be performed in the isolation room are listed are provided so that the patients can select the desired occupation through face to face interview with the therapist. 
    - Occupational therapist visits the isolation ward once a day (20 minutes).
    - Conduct 5 times (DAY2~6)
    
    2. Tele-consultation(Participation in occupational activities)
    - Conduct on the control group.
    - Participate in occupational activities through telephone interviews with occupational therapists.
    - A list(knitting, curling books, figure making, and masterpiece puzzles etc) in which the occupations that can be performed in the isolation room are listed are provided so that the patients can select the desired occupation through tele-interview with the therapist. 
    - Educate patient and check over the phone.
    - Therapist visits the room to provide the relevant product.
    - Conduct 5 times (DAY2~6).
    
    3. Medical and conservative treatment
    - Isolation and conservative treatment according to COVID-19 response guidelines
    - Implemented according to the patient's condition by medical staff
    Number of Arms 2
    Arm 1

    Arm Label

    Experimental Group

    Target Number of Participant

    100

    Arm Type

    Experimental

    Arm Description

    1. Face to fact intervention(Participation in occupational activities)
    - A total of 5 sessions, once a day 
    
    2. Medical and conservative treatment
    - Isolation and conservative treatment according to COVID-19 response guidelines
    - Implemented according to the patient's condition by medical staff
    Arm 2

    Arm Label

    Control Group

    Target Number of Participant

    100

    Arm Type

    No intervention

    Arm Description

    1. Tele-consultation(Participation in occupational activities)
    - A total of 5 sessions, once a day 
    
    2. Medical and conservative treatment
    - Isolation and conservative treatment according to COVID-19 response guidelines
    - Implemented according to the patient's condition by medical staff
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (U00-U99)Codes for special purposes 
       (U07.1)Coronavirus disease 2019, virus identified [COVID-19, virus identified] 

    COVID19
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    1. Diagnosed with COVID 19 due to positive in the PCR test
    2. Classified as mild by medical staff
      : Oxygen saturation is upper than 95%
    3. isolated in facility
    4. No history of diagnosis of psychiatric disorders 
    5. No communication problems 
    6. Adults 18 years of age or older
    7. Understands the purpose of the research and voluntarily agrees. 
    Exclusion Criteria
    1. Not medically stable
    2. Have difficulty of using Korean or communication problems
    3. Have history of diagnosis of psychiatric disorders 
    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
    WHOQOL(World Health Organization Quality of Life Assessment Instrument-BRIEF)
    Timepoint
    Before intervention once, after intervention once. 
    Secondary Outcome(s) 1
    Outcome
    VAS(Visual Analogue Scale)
    Timepoint
    Before intervention once, after intervention once. 
    Secondary Outcome(s) 2
    Outcome
    SAS(self rating anxiety scale)
    Timepoint
    Before intervention once, after intervention once. 
    Secondary Outcome(s) 3
    Outcome
    VAS(Visual Analogue Scale)
    Timepoint
    Before intervention once, after intervention once. 
    Secondary Outcome(s) 4
    Outcome
    PHQ-9(Patient Health Questionnaire-9)
    Timepoint
    Before intervention once, after intervention once. 
    Secondary Outcome(s) 5
    Outcome
    MSBS-8(Multidimensional State Boredom Scale-8)
    Timepoint
    Before intervention once, after intervention once. 
    Secondary Outcome(s) 6
    Outcome
    ISI(Insomnia severity index)
    Timepoint
    Before intervention once, after intervention once. 
  • 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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