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临床试验/NCT02541851
NCT02541851终止不适用

Chronic Pain After Surgical Intensive Care Admission: Incidence and Risk Factors: the DOLOCHROREA Study

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
100
试验地点
1
主要终点
Incidence of chronic pain

研究概览

简要总结

The acute pain remains unfortunately a major health problem in intensive care patients. Several factors, such as cancer, traumatic injuries, surgery, scars, diagnostic or therapeutic procedure, could contribute to an increase in the incidence or in the intensity of acute pain. The acute pain could impact on the prognosis of intensive care patients and on the patients perception of the quality of care.

Moreover, the acute pain could lead to a long-term chronic pain syndrome. The chronic pain after intensive care admission could threaten the physical and psychological recovery after the stay in the intensive care unit (ICU).

If many studies have been conducted to improve the management of the acute pain in the ICU, only few data exist on the incidence and the risk factors of the chronic pain after a stay in a surgical intensive care.

The aim of the DOLOCHROREA study is to assess the incidence and the risk factors of 6-month chronic pain after a stay in our surgical ICU.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admission in the surgical critical care unit of the University Hospital of Besançon from February 2015
  • Age over 18 yr old
  • Informed consent

排除标准

  • Age under 18 yr old
  • Death within the first 6 months after the end of the stay in the surgical intensive unit of the University Hospital of Besançon
  • Glasgow Coma Score under 8 at admission and/or at discharge
  • Planned admission after elective surgery
  • Medical history of cognitive disorder
  • Refuse to participate

结局指标

主要结局

Incidence of chronic pain

时间窗: 6 months

Pain is defined by The International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage". Pain exceeding the average period of healing of 2 to 3 months and ceasing to serve any apparent protective function is defined as chronic pain. The incidence of chronic pain will be assessed by using a validated french version of the Brief Pain Inventory during a phone call at 6 month after the end of the stay in our intensive care unit.

次要结局

  • Incidence of anxiety and depression(6 months)
  • Incidence of neuropathic pain(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillaume BESCH

M.D.

Centre Hospitalier Universitaire de Besancon

研究点 (1)

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