Clinical Trial: Assessment of the Contribution of Hypnosis in the Tolerance of the Bronchoscopy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Assessment of the Contribution of Hypnosis in the Tolerance of the Bronchoscopy
Brief Summary:
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.
Detailed Summary:
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:
If the eligibility criteria are present, it will be proposed to the patient to participate in a study to assess the tolerance of Examination under hypnosis. A fact sheet will be handed to him explaining the purpose of the study and the place of examination. If he agrees to participate, consent will be obtained in writing and will be randomized into one of two groups. He will fill a questionnaire clinical information and Anxiety Questionnaire HAD (Hospital Anxiety and Depression Scale). The examination is then conducted in endoscopy room. In the hypnosis group, the patient will benefit from an induction technique of hypnosis by a doctor trained in hypnosis and local anesthesia performed by the endoscopist. In the control group, only local anesthesia is practiced by the endoscopist. The waning, it will ask the patient and endoscopist to complete an evaluation of the tolerance of the examination questionnaire.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Groupe Hospitalier Paris Saint Joseph
Dates:
Date Received: May 9, 2016
Date Started: July 4, 2014
Date Completion: June 30, 2017
Last Updated: February 19, 2017
Last Verified: February 2017
