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临床试验/NCT04454333
NCT04454333已完成不适用

COVID-19 in Pain Perspective

Sisli Hamidiye Etfal Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 466 人开始时间: 2020年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
466
试验地点
1
主要终点
Numeric Rating Scale for Pain

研究概览

简要总结

In our hospital's Infectious Diseases and Clinical Microbiology service, patients who have been hospitalized due to Covid -19 infection have a musculoskeletal pain and headache during this process, and 466 patients will be recruited to compare them with the pre-disease state of the patients and to evaluate the pain status of the patients after treatment.

详细描述

This retrospectively designed study was carried out by analyzing SARS-CoV-2 infected and hospitalized patients in our hospital for 2 month. The patients, whose contact information can be accessed from the hospital records, will be called by phone and pain inquiries were made during the SARS-CoV-2 infection process. In addition, patients' demographic data, living conditions (number and characteristics of the person in the household), comorbidities, symptom inquiry related to infection, duration of symptoms, length of hospitalstay, pre-infection pain conditions and current pain, anxiety, depression levels and quality of life will be questioned.

The pain questioning include the painful body region/s, severity (Numeric Rating Scale), type of analgesic drugs used, and duration of use that occurred during infection. Anxiety and depression levels will be evaluated, hospital anxiety and depression scale (HADS), and quality of life will be evaluated with SF-12 health assessment questionnaire.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with positive PCR test results obtained from combined throat and nasopharyngeal swab samples
  • patients consistent with Covid-19 infection as a result of thorax computed tomography, although PCR test results were negative.

排除标准

  • Patients who have undergone surgery and trauma in the painful area in the past 3 months,
  • Patients with pathological disease that can cause underlying pain
  • Pregnant women
  • Those who have psychiatric illness and use psychiatric drugs
  • Presence of malignancy
  • Patients with severe cognitive deficits

结局指标

主要结局

Numeric Rating Scale for Pain

时间窗: up to 10 weeks

Evaluation of severity of pain for head, back-neck and extremities by Numeric Rating Scale. Scoring will be done between 0 minimum and 10 maximum values. Higher scores mean worse outcome.

Hospital Anxiety and Depression Scale (HADS)

时间窗: up to 10 weeks

Evaluation of patient's anxiety and depression level in hospital by Hospital Anxiety and Depression Scale (HADS). The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report screening scale. It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21. Higher scores mean a worse outcome.

SF-12 Health assesment Questionaire

时间窗: up to 10 weeks

Evaluation of patient's quality of life by SF-12 Health assesment Questionaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). Higher scores mean a better outcome.

次要结局

未报告次要终点

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aylin Ayyıldız

Medical Doctor

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (1)

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