跳至主要内容
临床试验/NCT02811107
NCT02811107Unknown不适用

Evaluation of Anxiety in Surgery Preoperative Area (ASDT)

Hospices Civils de Lyon0 个研究点目标入组 1,000 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
主要终点
Evaluation of anxiety in preoperative area, by using 3 questionnaires.

研究概览

简要总结

Anxiety is associated with discomfort but also with an increased risk of pain and/or analgesic consumption. A prescription of anxiolytics is very common in pre-anesthetic consultation but without considering the real anxiety level of the patients. The objective of this premedication is mainly to improve patient comfort, to reduce patient anxiety and to improve patient cooperation.

According to a study conducted in the 1990s, 40 to 80% of patients are anxious before surgery.

Consequences of anxiety are somatic (tachycardia, hypertension, difficulty to falling asleep), behavioural (aggressiveness, regression, fight against anaesthesia induction) and postoperative pain.

Preoperative area is a place of convergence for patients who need surgery or an interventional procedure.

Staying in the preoperative area may be a source of anxiety and may affect the patient management.

The investigators will interview patients undergoing surgery or interventional procedure to assess their level of anxiety, pain and their experiences during their stay in preoperative area. The objective is to analyse the level of anxiety and / or pain and their clinical consequences, and then to assess the relationship with any potential premedication.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient in preoperative area before surgery or interventional procedure
  • Patient to receive general anesthesia, local, locoregional, sedation,
  • Agreeing to participate in the study after receiving information note,
  • ≥ 18 years of age.

排除标准

  • < 18 years

结局指标

主要结局

Evaluation of anxiety in preoperative area, by using 3 questionnaires.

时间窗: Day 0

With 3 questionnaires: * visual analog scale of anxiety * APAIS score * COVI Score

次要结局

  • Evaluation of pain(Day 0)
  • Evaluation of patient premedication(Day 0)
  • Evaluation of sedation(Day 0)
  • Experiences of patient(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

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