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临床试验/NCT02775630
NCT02775630进行中(未招募)不适用

Assessment of the Contribution of Hypnosis in the Tolerance of the Bronchoscopy

Fondation Hôpital Saint-Joseph2 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2014年7月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
113
试验地点
2
主要终点
Assessment of timing change of endoscopy

研究概览

简要总结

Bronchoscopy is an examination performed routinely in pulmonology. This exam is considered as uncomfortable by nearly 60% of patients, especially due to respiratory blocking sensation, cough and nausea it causes, despite the use of a local anesthetic. Conversely, this examination is rarely performed under general anesthesia in hospitals in France, because it lengthens the duration of the procedure, increases its cost and can be dangerous for the respiratory failure patient.

Hypnosis is an altered state of consciousness between wakefulness and sleep, which can cause the patient to ignore the reality in which he is focusing his attention on his imagination, reducing his anxiety, his painful or unpleasant perceptions and their memorization.

The hypnosis benefit has already been evaluated in the control of pain and anxiety in many medical situations, surgical, obstetric and dental. In endoscopy, the results are mixed. In bronchoscopy, hypnosis has, to our knowledge, not been evaluated.

In a preliminary study in the endoscopy unit of the Hospital Saint Joseph, involving 66 patients, investigators showed that bronchoscopy was poorly tolerated in more than half of patients and that this poor tolerance was correlated to the level anxiety of patients, but 75% of patients surveyed would prefer the waning redo the examination in the same conditions if their health required it, rather than using a general anesthetic. Investigators then hypothesized that hypnosis would improve tolerance bronchoscopy under local anesthesia, without the need for general anesthesia.

详细描述

Primary objective:

To compare the safety of bronchoscopy performed under local anesthesia and hypnosis to that performed under local anesthesia alone.

Secondary objectives:

  • Self-assessment of pain, difficulty breathing, coughing and sensation of nausea experienced by the patient.
  • Straight-tolerance assessment of the review by the endoscopist.
  • Evaluation of the quality of implementation of the review by the endoscopist.
  • Evaluation of the amount of local anesthetic used during the examination.
  • Measure the length of the review.

Development of the study:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

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

  • Before performing a bronchoscopy under his medical care
  • No opposition to participate in the study

排除标准

  • Poor understanding of the French language
  • major hearing impairment
  • severe cognitive or psychiatric disorders

结局指标

主要结局

Assessment of timing change of endoscopy

时间窗: At Day 0, Time laps Start at the input of the endoscopy suite and stop when the output of the endoscopy suite

Anxiety Questionnaire HAD (Hospital Anxiety and Depression Scale)

时间窗: At Day 0 within 30 minutes after the exam

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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