Clinical trial NCT05658939: Safety and Effectiveness of Integrative Korean Medicine Treatment for Traffic Accident During Pregnancy
Official title: Safety and Effectiveness of Integrative Korean Medicine Treatment for Traffic Accident During Pregnancy : Retrospective Chart Review Study and Survey Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traffic Accident
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 1, 2018 to April 22, 2022, patients who visited Daejeon Jasaeng Korean Medicine Hospital due to a traffic accident during pregnancy were included.

Brief summary: The purpose of this study is to reveal the efficacy and safety of integrative korean medicine treatment for pregnant women who suffered a traffic accident. A retrospective chart review and follow-up were conducted.

From January 1, 2018 to April 22, 2022, pregnant women who visited an korean medicine hospital due to a traffic accident were subjected to a retrospective study of patient medical records and follow-up.

Detailed description: Medical records of selected patients will be analyzed, and telephone or internet surveys will be conducted for each patient. The survey questions are Numeric rating scale(NRS), Neck disability index(NDI) score, Oswestry Disability Index(ODI) score, Shoulder Pain and Disability Index(SPADI) score, The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) score, EuroQol 5-dimension 5-level(EQ-5D-5L) score and patient global impression of change (PGIC) score, etc.

Eligibility criteria: Inclusion Criteria:

* Patients who visited hospital due to symptoms caused by a traffic accident during pregnancy and received one or more korean medicine treatment as an inpatient or outpatient treatment
* Patients who understand the purpose and contents of the study and agree to participate in the study
* Patients with communication skills and mental/physical ability to respond appropriately to questionnaires

Exclusion Criteria:

* Patients under the age of 18 at the time of the first visit
* Patients who received treatment without being aware of pregnancy
* Patients who have undergone only consultation or Western treatment at the hospital
* Patients whose participation in the study is difficult for the researcher to judge

Primary outcomes:
measure: Effectiveness Outcome : Numeric rating scale (NRS)
timeFrame: Finish survey by August 2022
Secondary outcomes:
measure: Effectiveness Outcome : Neck Disability Index (NDI)
timeFrame: Finish survey by August 2022
measure: Effectiveness Outcome : Oswestry Disability Index (ODI)
timeFrame: Finish survey by August 2022
measure: Effectiveness Outcome : Shoulder Pain and Disability Index (SPADI)
timeFrame: Finish survey by August 2022
measure: Effectiveness Outcome : The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Finish survey by August 2022
measure: Effectiveness Outcome : EuroQol 5-dimension 5-level (EQ-5D-5L)
timeFrame: Finish survey by August 2022
measure: Effectiveness Outcome : Patient Global Impression of Change (PGIC)
timeFrame: Finish survey by August 2022
Other outcomes:
measure: Survey ( Obstetric and neonatal outcomes checklist)
timeFrame: Finish survey by August 2022
measure: Number of participants with Symptoms related/not related to pregnancy
timeFrame: Finish survey by August 2022
Locations:
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Daejeon Jaseng Hospital of Korean Medicine
name: Sunah Kim
role: PRINCIPAL_INVESTIGATOR
References: