Safety and Effectiveness of Integrative Korean Medicine Treatment for Traffic Accident During Pregnancy

NCT05658939 | Completed

• 1 other identifier: JS-CT-2022-05
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Traffic Accident

Outcome Measures

Primary Outcomes (1)

• Effectiveness Outcome : 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 scores were collected for each patient's chief complaints. For outpatients, the NRS scores on the first and last outpatient visit days, and for inpatients, the NRS scores on the day of admission and discharge were collected through the electronic medical records(EMRs). In the follow-up questionnaire, the current NRS score was also collected for each patient's chief complaints.

  Finish survey by August 2022

Secondary Outcomes (6)

• Effectiveness Outcome : Neck Disability Index (NDI)

  Finish survey by August 2022

• Effectiveness Outcome : Oswestry Disability Index (ODI)

  Finish survey by August 2022

• Effectiveness Outcome : Shoulder Pain and Disability Index (SPADI)

  Finish survey by August 2022

• Effectiveness Outcome : The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Finish survey by August 2022

• Effectiveness Outcome : EuroQol 5-dimension 5-level (EQ-5D-5L)

  Finish survey by August 2022

Other Outcomes (2)

• Survey ( Obstetric and neonatal outcomes checklist)

  Finish survey by August 2022

• Number of participants with Symptoms related/not related to pregnancy

  Finish survey by August 2022

Interventions

Phone/Internet survey OTHER

A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone/internet for patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, 35262, South Korea

Location

Study Officials

• Sunah Kim

  Daejeon Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 21, 2022
• Study Start: May 2, 2022
• Primary Completion: July 22, 2022
• Study Completion: August 18, 2022
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)