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

Pediatric ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410586
• Other study ID #: JS-CT-2023-11
• Status: Recruiting
• Start date: February 5, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2024
• Source: Jaseng Medical Foundation
• Contact: In-Hyuk Ha, Dr
• Phone: 1577-0007
• Email: hanihata[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric ALL
• Traffic Accident

Locations

Country	Name	City	State
Korea, Republic of	Bundang Jaseng Hospital of Korean Medicine	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Finish survey by October 2024
Secondary	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.	Finish survey by October 2024
Secondary	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.	Finish survey by October 2024
Secondary	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.	Finish survey by October 2024
Secondary	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.	Finish survey by October 2024
Secondary	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.	Finish survey by October 2024
Secondary	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.	Finish survey by October 2024