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CompletedNCT06410586Updated Oct 21, 2024

Integrative Korean Medicine Treatment for Pediatrics After Traffic Accident: Retrospective Chart Review Study and Survey

An observational study in Pediatric ALL and Traffic Accident, sponsored by Jaseng Medical Foundation. Completed at 1 site in Korea, Republic of. Open to participants aged Up to 6 Years. Per ClinicalTrials.gov, last updated 2024-10-21.

Sponsored by Jaseng Medical Foundation · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
57
Ages
Up to 6 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Pediatric ALL
  • Traffic Accident
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In context

Lead sponsor

Jaseng Medical Foundation is the lead sponsor of 67 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 6 Years
Sexes eligible
All
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.

Inclusion criteria

  1. 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.
  2. Among the patients described in 1, those whose guardians understand the purpose and content of the research and consent to participate in the study.
  3. 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

Exclusion Criteria:

  1. Cases where only consultation was provided or only Western medical treatment was administered at our institution.
  2. Other cases deemed unsuitable for study participation by the researcher.
  3. Patients with a history related to the chief complaint.
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Study design

Observational model
Other
Time perspective
Other
Enrollment
57 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Finish survey by October 2024

Secondary outcomes

  1. 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.

    Time frame: Finish survey by October 2024

  2. 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.

    Time frame: Finish survey by October 2024

  3. 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.

    Time frame: Finish survey by October 2024

  4. 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.

    Time frame: Finish survey by October 2024

  5. 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.

    Time frame: Finish survey by October 2024

  6. 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.

    Time frame: Finish survey by October 2024

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Study locations

1 site
  • Bundang Jaseng Hospital of Korean Medicine
    Seongnam, Gyeonggi-do 13590, Korea, Republic of
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06410586
Lead sponsor
Jaseng Medical Foundation
Responsible party
Sponsor
First posted
May 13, 2024
Start date
Feb 5, 2024
Primary completion
Jul 12, 2024
Completion
Jul 12, 2024
Last update
Oct 21, 2024

Study contacts

In-Hyuk Ha, Dr
study chair · Bucheon Jaseng Hospital of Korean Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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