跳至主要内容
临床试验/NCT04546594
NCT04546594撤回不适用

Collection of Epidemiological Data on Pain Related to Orthopedic, Thoracic or Gynecological Surgery

University Hospital, Lille0 个研究点目标入组 500 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
500
主要终点
Descriptive analysis of the typology of pain in patients needing surgery.

研究概览

简要总结

The ALGOBASES project is an observational epidemiological study of pain through the collection of pain evaluation questionnaires and information with the aim of creating a descriptive "pain" evaluation in all patients who need to benefit from orthopedic, thoracic or gynecological surgery. The painful symptomatology will thus be evaluated in all its dimensions (demographic data, physical, psychological, socio-cultural components) and linked to the pathology justifying the specialized care. It is planned to collect the same data at each subsequent event in order to allow the determination of predictive factors, pain trajectories according to the type of surgery, and the profile of subjects at risk of acute or chronic postoperative pain.

研究设计

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

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient over 17 years old Patient needing orthopedic surgery Patient needing gynecological surgery Patient needing thoracic surgery Patient who has given written consent to participate in the trial. Socially insured patient Patient willing to comply with all study procedures and study duration

排除标准

  • Age under 18 years old
  • Non-communicating patient
  • Patient does not understand French
  • Patient without social protection
  • Patient refusing to participate

结局指标

主要结局

Descriptive analysis of the typology of pain in patients needing surgery.

时间窗: Baseline

The typology of pain will be analyzed on the basis of responses to questionnaires on the affective and sensory dimension of pain, quality of life, depression, anxiety and catastrophizing

次要结局

  • Hospital Anxiety Depression scale (HAD) according to pain(Baseline and follow-up over a period of five years during post-operative or pain medical consultation)
  • EQD5 according to pain(Baseline and follow-up over a period of five years during post-operative or pain medical consultation)
  • Identification of factors predictive of acute or chronic pain.(Baseline and at three months, six months, one year)
  • Descriptive analysis of specific symptomatology of pain Description of the general and painful symptomatology in patients needing surgery.(follow-up over a period of five years during post-operative or pain medical consultation)
  • Pain Catastrophizing Scale (PCS) according to pain(Baseline and follow-up over a period of five years during post-operative or pain medical consultation)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

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