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临床试验/NCT05658939
NCT05658939已完成不适用

Safety and Effectiveness of Integrative Korean Medicine Treatment for Traffic Accident During Pregnancy : Retrospective Chart Review Study and Survey Research

Jaseng Medical Foundation1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2022年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
Effectiveness Outcome : Numeric rating scale (NRS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Effectiveness Outcome : Numeric rating scale (NRS)

时间窗: Finish survey by August 2022

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.

次要结局

  • Effectiveness Outcome : Neck Disability Index (NDI)(Finish survey by August 2022)
  • Effectiveness Outcome : Shoulder Pain and Disability Index (SPADI)(Finish survey by August 2022)
  • Effectiveness Outcome : Oswestry Disability Index (ODI)(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)
  • Effectiveness Outcome : Patient Global Impression of Change (PGIC)(Finish survey by August 2022)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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