Skip to main content
OpenTrials
Completed

NCT Number: NCT06410586

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

A retrospective chart review study and survey research to verify the efficacy and safety of integrative Korean medicine treatment for pediatric traffic accident patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pediatric ALL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Traffic Accident

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bundang Jaseng Hospital of Korean Medicine

Seongnam-si, Gyeonggi-do, 13590, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 13, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.