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Clinical Trials/NCT06410586
NCT06410586
Completed
Not Applicable

Safety and Efficacy of Integrative Korean Medicine Treatment for Children After Traffic Accident : Retrospective Chart Review Study and Survey Research

Jaseng Medical Foundation1 site in 1 country57 target enrollmentFebruary 5, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric ALL
Sponsor
Jaseng Medical Foundation
Enrollment
57
Locations
1
Primary Endpoint
Numeric rating scale (NRS)
Status
Completed
Last Updated
last year

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
February 5, 2024
End Date
July 12, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Satisfaction with integrative Korean medicine survey(Finish survey by October 2024)
  • Oswestry Disability Index(ODI)(Finish survey by October 2024)
  • The five level version of EuroQol-5 Dimension (EQ-5D)(Finish survey by October 2024)
  • NDI(Finish survey by October 2024)
  • PedsQL™ Generic Core Scales(Finish survey by October 2024)
  • PedsQL™ Infant Scales(Finish survey by October 2024)

Study Sites (1)

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