Pediatric ALLNCT06410586
Integrative Korean Medicine Treatment for Pediatrics After Traffic Accident: Retrospective Chart Review Study and Survey
An observational study of Pediatric ALL and Traffic Accident, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
A retrospective chart review study and survey research to verify the efficacy and safety of integrative Korean medicine treatment for pediatric traffic accident patients. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Pediatric ALL, Traffic Accident
- How many people
- 57 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Feb 2024to 12 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bundang Jaseng Hospital of Korean Medicine
Seongnam-si, Gyeonggi-do, 13590
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric ALL, Traffic Accident
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS)
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.
Measured: Finish survey by October 2024
Secondary outcomes (6)
Oswestry Disability Index(ODI)
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.
Measured: Finish survey by October 2024
NDI
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.
Measured: Finish survey by October 2024
The five level version of EuroQol-5 Dimension (EQ-5D)
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.
Measured: Finish survey by October 2024
PedsQL™ Generic Core Scales
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.
Measured: Finish survey by October 2024
PedsQL™ Infant Scales
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.
Measured: Finish survey by October 2024
Satisfaction with integrative Korean medicine survey
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.
Measured: Finish survey by October 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start5 Feb 2024
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- In-Hyuk Ha, Dr, Study chair, Bucheon Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410586
- Sponsor's protocol ID
- JS-CT-2023-11
- Status last verified
- May 2024
- First submitted
- 2 Apr 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Integrative Korean Medicine Treatment for Children After Traffic Accident : Retrospective Chart Review Study and Survey Research
- ClinicalTrials.gov ID
- NCT06410586
- Acronym / sponsor ID
- JS-CT-2023-11
- Conditions
- Pediatric ALL, Traffic Accident
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A retrospective chart review study and survey research to verify the efficacy and safety of integrative Korean medicine treatment for pediatric traffic accident patients.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Oswestry Disability Index(ODI)
Time frame: Finish survey by October 2024
NDI
Time frame: Finish survey by October 2024
The five level version of EuroQol-5 Dimension (EQ-5D)
Time frame: Finish survey by October 2024
PedsQL™ Generic Core Scales
Time frame: Finish survey by October 2024
PedsQL™ Infant Scales
Time frame: Finish survey by October 2024
Satisfaction with integrative Korean medicine survey
Time frame: Finish survey by October 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Hyuk Ha, Dr study chair
Bucheon Jaseng Hospital of Korean Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric ALL and Traffic Accident, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (NRS) (time frame: Finish survey by October 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.