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Clinical Trials/NCT02775630
NCT02775630Active, not recruitingNot Applicable

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

Fondation Hôpital Saint-Joseph1 site in 1 country113 target enrollmentStarted: July 4, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
113
Locations
1
Primary Endpoint
Assessment of timing change of endoscopy

Study Overview

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 Description

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Examination under hypnosis in addition to local anesthesia

Experimental

Patients will have hypnosis add-on local anesthesia

Intervention: hypnosis (Procedure)

Examination under local anesthesia

No Intervention

Patients will receive a local anesthesia only without hypnosis

Outcomes

Primary Outcomes

Assessment of timing change of endoscopy

Time Frame: 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)

Time Frame: At Day 0 within 30 minutes after the exam

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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