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
CRIS Registration Number |
KCT0006714 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Seoul National University Bundang Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Seoul National University Bundang Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (U00-U99)Codes for special purposes (U07.1)Coronavirus disease 2019, virus identified [COVID-19, virus identified] COVID19 |
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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)
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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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