Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Numeric Rating Scale(NRS) of post-accident syndromes |
The severity of post-accident syndrome will be assessed using NRS. NRS is a scale in which the patient indicates their subjective severity of symptoms as a whole number from 0 to 10. The participant is asked to report their severity of post-accident syndrome using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'. |
Change from baseline to 4 months |
|
Secondary |
Numeric Rating Scale(NRS) of musculoskeletal complaints of post-accident syndromes |
The severity of musculoskeletal complaints of post-accident syndrome will be assessed using NRS. The participant is asked to report their severity of musculoskeletal complaints(post neck pain, lower back pain, shoulder pain, knee pain, etc) using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain or discomfort imaginable'. |
Baseline(week 1-1), week 3-1, week 5, week 9, week 17 |
|
Secondary |
Numeric Rating Scale(NRS) of neurological complaints of post-accident syndromes |
The severity of neurological complaints of post-accident syndrome will be assessed using NRS. The participant is asked to report their severity of neurological complaints(headache, dizziness, etc) using NRS, where 0 indicates 'no discomfort' and 10 indicates 'the most severe discomfort imaginable'. |
Baseline(week 1-1), week 3-1, week 5, week 9, week 17 |
|
Secondary |
Numeric Rating Scale(NRS) of psychiatric complaints of post-accident syndromes |
The severity of psychiatric complaints of post-accident syndrome will be assessed using NRS. The participant is asked to report their severity of psychiatric complaints(anxiety, depression, anger, insomnia etc) using NRS, where 0 indicates 'no discomfort' and 10 indicates 'the most severe discomfort imaginable'. |
Baseline(week 1-1), week 3-1, week 5, week 9, week 17 |
|
Secondary |
Numeric Rating Scale(NRS) of digestive systemic complaints of post-accident syndromes |
The severity of digestive systemic complaints of post-accident syndrome will be assessed using NRS. The participant is asked to report their severity of digestive systemic complaints(indigestion, loss of appetite, etc) using NRS, where 0 indicates 'no discomfort' and 10 indicates 'the most severe discomfort imaginable'. |
Baseline(week 1-1), week 3-1, week 5, week 9, week 17 |
|
Secondary |
Numeric Rating Scale(NRS) of general symptoms of post-accident syndromes |
The severity of general symptoms of post-accident syndrome will be assessed using NRS. The participant is asked to report their severity of general symptoms(fatigue, powerlessness, etc) using NRS, where 0 indicates 'no discomfort' and 10 indicates 'the most severe discomfort imaginable'. |
Baseline(week 1-1), week 3-1, week 5, week 9, week 17 |
|
Secondary |
Impact of Event Scale-Revised-Korean (IES-R-K) |
The IES-R-K is a 22-item self-report scale that evaluates subjective stress caused by traumatic events. Each item is rated on a scale of 0 (not at all) to 4 (extremely) of the severity of symptoms based on the past week, with a total score ranging from 0 to 88. Although it is not generally recommended for the diagnosis of PTSD, it is an evaluation scale widely used in trauma-related clinical studies. |
Baseline(week 1-1), week 3-1, week 5, week 9, week 17 |
|
Secondary |
5-level EuroQol 5-dimension (EQ-5D-5L) |
The EQ-5D is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, the investigators will use the Korean version of the EQ-5D, which has been demonstrated to be valid. |
Baseline(week 1-1), week 3-1, week 5, week 9, week 17 |
|
Secondary |
Short-Form-12 Health Survey version2 (SF-12 v2) |
SF-12 version 2 is a questionnaire that evaluates health-related quality of life (HRQoL). It consists of 12 items in 8 areas (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health). |
Baseline(week 1-1), week 3-1, week 5, week 9, week 17 |
|
Secondary |
Patient Global Impression of Change (PGIC) |
The PGIC is an index that assesses improvements in post-accident syndromes caused by traffic accident. Participants rate the improvement in post-accident syndromes after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse) |
week 5, week 9, week 17 |
|
Secondary |
Economic evaluation question |
In order to measure cost items, a questionnaire with questions measuring medical expenses, non-medical expenses, time costs, productivity loss costs, etc. is used. |
Through study completion, an average of 4 months |
|
Secondary |
Drug Consumption |
Check the type and dose of drugs taken during the study period every visit |
Through study completion, an average of 4 months |
|
Secondary |
Adverse events |
Check adverse events every visit |
Through study completion, an average of 4 months |
|