Status Approved
First Submitted Date
2018/11/05
Registered Date
2019/03/25
Last Updated Date
2021/07/15
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003660 |
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Unique Protocol ID | WMCSB 201802-10 |
Public/Brief Title | A survey on the posttraumatic stress disorder and aute stress disorder in traffic injuries |
Scientific Title | A survey on the prevalence and validity of screening test for acute stress disorder and posttraumatic stress disorder in traffic injuries |
Acronym | TA_PTSD_ASD |
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 | WMCSB 201809-72-180647 |
Approval Date | 2018-09-11 |
Institutional Review Board Name | Institutional Review Board of Wonkwang University Sanbon Hospital |
Institutional Review Board Address | Wonkwang University Sanbon Hospital, 321 Sanbon-ro Gunpo city Gyeonggi-Do |
Institutional Review Board Telephone | 031-390-2586 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Hyung Won Kang |
Title | professor |
Telephone | +82-31-390-2762 |
Affiliation | Wonkwang University Sanbon Hospital |
Address | 321, Sanbon-ro Gunpo City, Gyeonggi-do |
Contact Person for Public Queries | |
Name | Hyung Won Kang |
Title | Professor |
Telephone | +82-31-390-2762 |
Affiliation | Wonkwang University Sanbon Hospital |
Address | 321, Sanbon-ro Gunpo City, Gyeonggi-do |
Contact Person for Updating Information | |
Name | Moon Joo Cheong |
Title | Ph.D |
Telephone | +82-31-390-2763 |
Affiliation | Hanyang University |
Address | 222, Wangsimni-ro, Seongdong-gu, Seoul, 04763, Korea |
4. Status
Study Site | Multi-center Number of center : 2 | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2018-12-11 Actual | |
Target Number of Participant | 300 | |
Primary Completion Date | 2019-12-11 , Actual | |
Study Completion Date | 2020-07-29 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Wonkwang University Sanbon Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2018-12-11 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Pusan National University Korean Medicine Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2019-12-11 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Pusan National University Korean Medicine Hospital |
Organization Type | Medical Institute |
Project ID | HB16C0013 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Wonkwang University Sanbon Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Although there is a high incidence of acute stress disorder(ASD) and post traumatic stress disorder(PTSD) caused by traffic accidents, patients who suffer from ASD and PTSD after traffic accidents don't usually get psychological intervention in the beginning of the accident. The purpose of this study is to make the rationale for Korean medicine clinical practice guidelines recommendation for ASD and PTSD in primary care and to verify the usefulness of existing testing tools to screen the ASD and PTSD. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-only |
Time Perspective | Cross-sectional |
Target Number of Participant | 300 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label The Group of patient who experienced a traffic accident |
Cohort/Group Description A person who has experienced a traffic accident and who is between the ages of 20 and 70 years old and who has voluntarily agreed to the written consent of the patient or the legal representative in the clinical trial agreement will be researched about the Acute Stress Disorder and Post Traumatic Stress Diorder. This study will confirm the prevalence of Acute Stress Disorder and Post Traumatic Stress Disorder in traffic accident victims. |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Among the residents of Seoul, Gyeonggi (Gunpo, Incheon), Gwangju, and Yangsan, who have experienced traffic accidents, those who going to university hospitals and Oriental hospitals are between 20 and 70 years of age and have voluntarily agreed to the written consent of the patient or legal representative to be. There is no restriction on gender. |
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Sampling Method | Quota sample variant form of the subjective judgment sampling method among the non-probabilistic sampling methods, will be used to carry out involving the subjective judgment of the experts in order to obtain a representative sampling. |
Condition(s)/Problem(s) |
* (F00-F99)Mental and behavioural disorders (F43.1)Post-traumatic stress disorder Posttraumatic Stress Disorders Acute Stress Disorders |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~70Year |
|
Description 1) Age: 20 to 70 years male, female adult 2) The patient who experienced a traffic accident 3) The patient who has been more than 3 days and less than 1 year since a traffic accident 4) The patient who voluntarily agrees in writing to the clinical trial agreement |
|
Exclusion Criteria |
1) The patient with a history of major psychiatric disorders such as schizophrenia, delusional disorder, bipolar disorder, alcohol or substance abuse disorder diagnosed by The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-IV)before a traffic accident. 2) The patient who had cervical spine or lumbar surgery before a traffic accident 3) The patient with chronic disease that may affect the outcome of the clinical study 4) The patient with congenital spinal disease 5) The patient who participated in other clinical studies within a month 6) The patient who can not communicate normally due to dementia or mild cognitive impairment. 7) Pregnant woman |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | Basic information |
|
Timepoint | At the time of survey |
|
Secondary Outcome(s) 1 | ||
Outcome | PC-PTSD-5(The Primary Care PTSD Screen for DSM-5) |
|
Timepoint | At the time of survey |
|
Secondary Outcome(s) 2 | ||
Outcome | PCL-5-K(Korean version of PTSD Checklist-5) |
|
Timepoint | At the time of survey |
|
Secondary Outcome(s) 3 | ||
Outcome | HADS(Hospital anxiety and depression scale) |
|
Timepoint | At the time of survey |
|
Secondary Outcome(s) 4 | ||
Outcome | CSEI-S(The Core Seven-Emotions Inventory Short Form) |
|
Timepoint | At the time of survey |
|
Secondary Outcome(s) 5 | ||
Outcome | NRS((Numeric Rating Scale) |
|
Timepoint | At the time of survey |
|
Secondary Outcome(s) 6 | ||
Outcome | The instrument of pattern identification for jing ji and zheng chong |
|
Timepoint | At the time of survey |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2020. 12 |
Way of Sharing | Available on Request
(onp21@hanmail.net) |
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