NCT06410586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2024

Completed
Last Updated

October 21, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

April 2, 2024

Last Update Submit

October 17, 2024

Conditions

Outcome Measures

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.

    Finish survey by October 2024

Secondary Outcomes (6)

  • Oswestry Disability Index(ODI)

    Finish survey by October 2024

  • NDI

    Finish survey by October 2024

  • The five level version of EuroQol-5 Dimension (EQ-5D)

    Finish survey by October 2024

  • PedsQL™ Generic Core Scales

    Finish survey by October 2024

  • PedsQL™ Infant Scales

    Finish survey by October 2024

  • +1 more secondary outcomes

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bundang Jaseng Hospital of Korean Medicine

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

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • In-Hyuk Ha, Dr

    Bucheon Jaseng Hospital of Korean Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2024

First Posted

May 13, 2024

Study Start

February 5, 2024

Primary Completion

July 12, 2024

Study Completion

July 12, 2024

Last Updated

October 21, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations