Clinical trial NCT06410586: Integrative Korean Medicine Treatment for Pediatrics After Traffic Accident: Retrospective Chart Review Study and Survey
Official title: Safety and Efficacy of Integrative Korean Medicine Treatment for Children After Traffic Accident : Retrospective Chart Review Study and Survey Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric ALL
Traffic Accident
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 57
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

Eligibility 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:

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.

Primary outcomes:
measure: Numeric rating scale (NRS)
timeFrame: Finish survey by October 2024
Secondary outcomes:
measure: Oswestry Disability Index(ODI)
timeFrame: Finish survey by October 2024
measure: NDI
timeFrame: Finish survey by October 2024
measure: The five level version of EuroQol-5 Dimension (EQ-5D)
timeFrame: Finish survey by October 2024
measure: PedsQL™ Generic Core Scales
timeFrame: Finish survey by October 2024
measure: PedsQL™ Infant Scales
timeFrame: Finish survey by October 2024
measure: Satisfaction with integrative Korean medicine survey
timeFrame: Finish survey by October 2024
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Bundang Jaseng Hospital of Korean Medicine
state: Gyeonggi-do
Study officials:
affiliation: Bucheon Jaseng Hospital of Korean Medicine
name: In-Hyuk Ha, Dr
role: STUDY_CHAIR
References: