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临床试验/NCT02857322
NCT02857322Unknown不适用

Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
88
试验地点
2
主要终点
experiences of the perioperative period

研究概览

简要总结

The experimental strategy is to develop a specific device about the anesthetic and surgical acts for a subject with a documented psychiatric condition and to benefit from surgery. This device is based on 3 stages: pre-operative phase, Phase perioperative and postoperative phase. A nurse anesthetist will come into contact with the subject the day before surgery. This contact will be concomitant with the pre-anesthesia visit. She explained about the general organization of the arrival in the operating room. The interview will be a minimum of 15 minutes and beyond if necessary. This will be accompanying this the next day in the operating room in order to optimize its hospitality and installing the block, guide the subject through all the steps before falling asleep. Finally, even accompanying will be present upon awakening the subject in the recovery room.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

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

  • adult subject;
  • Subject with chronic mental illness defined by ICD-10 classification [ICD-10, 1992], corresponding to psychoses say no emotional or affective psychoses say;
  • Subject to which mental pathology is evolving for more than 6 months;
  • Topic targeted for elective surgery;
  • Topic judged capable of performing a self-administered questionnaire;

排除标准

  • minor, pregnant or nursing women, about not being affiliated to the social security scheme, subject under guardianship;
  • Subject with a mental illness do not belong to sections of ICD-10 contained in "inclusion criteria";
  • Subject to benefit from surgery as part of the emergency;

结局指标

主要结局

experiences of the perioperative period

时间窗: second day

assessment using a self-administered questionnaire called EVAN. This is a standardized questionnaire and validated, whose purpose is to understand the experience of perioperative anesthesia multidimensional way. It contains 28 items describing 6 dimensions (anxiety, discomfort, fear, pain and discomfort, explanations, needs). dimensional scores range from 0 (worst experience) to 100 (best experience).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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