- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06410586
Integrative Korean Medicine Treatment for Pediatrics After Traffic Accident: Retrospective Chart Review Study and Survey
May 10, 2024 updated by: Jaseng Medical Foundation
Safety and Efficacy of Integrative Korean Medicine Treatment for Children After Traffic Accident : Retrospective Chart Review Study and Survey Research
A retrospective chart review study and survey research to verify the efficacy and safety of integrative Korean medicine treatment for pediatric traffic accident patients.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This study is a long-term follow-up observational study targeting patients aged 0 to 6 years who visited any of the seven branches of Jaseng Hospital of Korean Medicine for outpatient and inpatient treatments after traffic accident injuries.
After obtaining consent from the guardians, retrospective collection of medical records and computer data for traffic accident patients aged 0-6 will be conducted, followed by prospective surveys through Google Forms or phone interviews with the guardians.
This data will be used for causal and factor analysis.
Study Type
Observational
Enrollment (Estimated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: In-Hyuk Ha, Dr
- Phone Number: 1577-0007
- Email: hanihata@gmail.com
Study Contact Backup
- Name: Yoon-Jung Lee, Dr
- Phone Number: 10-4509-0090
- Email: yoonjung3453@jaseng.org
Study Locations
-
-
Gyeonggi-do
-
Seongnam, Gyeonggi-do, Korea, Republic of, 13590
- Recruiting
- Bundang Jaseng Hospital of Korean Medicine
-
Contact:
- Yoon-Jung Lee, Dr
- Phone Number: 1577-0007
- Email: yoonjung3453@jaseng.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients aged 0 to 6 years who visited one of the seven branches of Jaseng Hospital of Korean Medicine for outpatient and inpatient treatments following traffic accident injuries, from January 1, 2019, to June 30, 2023, and who meet the inclusion criteria.
Description
Inclusion Criteria:
- Patients aged 0 to 6 years who have visited the institution for symptoms caused by a traffic accident and have received at least one session of integrative Korean medicine treatment as inpatient or outpatient care.
- Among the patients described in 1, those whose guardians understand the purpose and content of the research and consent to participate in the study.
- Among the patients described in 1, those whose guardians have the communicative ability, as well as the mental and physical capacity to respond appropriately to surveys.
Exclusion Criteria:
- Cases where only consultation was provided or only Western medical treatment was administered at our institution.
- Other cases deemed unsuitable for study participation by the researcher.
- Patients with a history related to the chief complaint.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric rating scale (NRS)
Time Frame: Finish survey by October 2024
|
NRS uses an 11-point scale to evaluate current neck pain and radiating pain where no pain is indicated by '0', and the worst pain imaginable by '10'.
NRS was assessed long term follow up.
|
Finish survey by October 2024
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oswestry Disability Index(ODI)
Time Frame: Finish survey by October 2024
|
ODI is a 10-item questionnaire developed to evaluate the degree of disability for lower back pain.
Each item is divided into 6 levels, and 0 to 5 points are awarded.
The higher the score, the greater the degree of disability.
We will conduct an validated Korean NDI questionnaire ODI was assessed long term follow up.
|
Finish survey by October 2024
|
NDI
Time Frame: Finish survey by October 2024
|
Functional disability questionnaire.
The possible range of each item score is 0 to 5. Total score range: 0 (better outcome) to 50 (worse outcome) In this study, the validated Korean version questionnaire will be used.
NDI was assessed long term follow up.
|
Finish survey by October 2024
|
The five level version of EuroQol-5 Dimension (EQ-5D)
Time Frame: Finish survey by October 2024
|
EQ-5D is most widely used as a method of indirectly calculating the quality of life from various aspects.
The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert.
(1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about) In this study, the validated Korean version questionnaire will be used.
EQ-5D was assessed long term follow up.
|
Finish survey by October 2024
|
PedsQL™ Generic Core Scales
Time Frame: Finish survey by October 2024
|
PedsQL™ Generic Core Scales is a 21(2-4 years old), 23(5-6 years old)-item questionnaire developed to evaluate the degree of quality of life.
Each item is divided into 5 levels, and 0 to 4 points are awarded.
The lesser the score, the greater the quality of life.
Questionnaire was assessed long term follow up.
|
Finish survey by October 2024
|
PedsQL™ Infant Scales
Time Frame: Finish survey by October 2024
|
PedsQL™ Generic Core Scales is a 36(0-12 months old), 45(13-24 months old)-item questionnaire developed to evaluate the degree of quality of life.
Each item is divided into 5 levels, and 0 to 4 points are awarded.
The lesser the score, the greater the quality of life.
Questionnaire was assessed long term follow up.
|
Finish survey by October 2024
|
Satisfaction with integrative Korean medicine survey
Time Frame: Finish survey by October 2024
|
For patient satisfaction questionnaire, a self-developed questionnaire will be used, including which treatment was satisfied or unsatisfaide, and why.
Questionnaire was assessed long term follow up.
|
Finish survey by October 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: In-Hyuk Ha, Dr, Bucheon Jaseng Hospital of Korean Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2024
Primary Completion (Estimated)
July 30, 2024
Study Completion (Estimated)
October 30, 2024
Study Registration Dates
First Submitted
April 2, 2024
First Submitted That Met QC Criteria
May 10, 2024
First Posted (Actual)
May 13, 2024
Study Record Updates
Last Update Posted (Actual)
May 13, 2024
Last Update Submitted That Met QC Criteria
May 10, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- JS-CT-2023-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric ALL
-
University of BirminghamCompletedCancer | Pediatric ALL | Pediatric Solid Tumor | Pediatric AMLUnited Kingdom, Australia, Netherlands
-
Samsung Medical CenterMinistry of Health, Republic of KoreaRecruitingRelapsed Pediatric AML | Refractory Pediatric AML | Relapsed Pediatric Solid Tumor | Refractory Pediatric Solid TumorKorea, Republic of
-
National Institute of Allergy and Infectious Diseases...Clinical Trials in Organ Transplantation in ChildrenCompletedPediatric Heart Transplantation | Pediatric Heart Transplant Recipients | Pediatric Cardiac TransplantationUnited States
-
University Hospital, Strasbourg, FranceTerminatedPediatric Lung Ultrasound | Pediatric Chest Radiography | Pediatric Lung DiagnosisFrance
-
TC Erciyes UniversityCompletedPediatric Cancer | Pediatric Brain Tumor | Pediatric Solid TumorTurkey
-
National Institute of Allergy and Infectious Diseases...National Heart, Lung, and Blood Institute (NHLBI)TerminatedPediatric Heart Transplantation | Pediatric Heart Transplant RecipientsUnited States, Canada
-
University of CalgaryCanadian Institutes of Health Research (CIHR); Alberta Children's Hospital; Stollery... and other collaboratorsNot yet recruitingPediatric Cancer | Pediatric Hematology
-
Hospital Moinhos de VentoNot yet recruitingAdolescent | Telemedicine | Critical Care | Pediatric | Intensive Care Units, Pediatric
-
Samsung Medical CenterMinistry of Health, Republic of KoreaNot yet recruitingRelapsed Pediatric Solid Tumor | Refractory Pediatric Solid TumorKorea, Republic of
-
Children's Healthcare of AtlantaEmory UniversityCompletedPediatric Preoperative Anxiety, Pediatric CopingUnited States