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

NCT02775630 | Unknown DMC

• 1 other identifier: FIBRO HYPNOSE
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory System Abnormalities

Outcome Measures

Primary Outcomes (2)

• Anxiety Questionnaire HAD (Hospital Anxiety and Depression Scale)

  At Day 0 within 30 minutes after the exam

• Assessment of timing change of endoscopy

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

Study Arms (2)

Examination under hypnosis in addition to local anesthesia

EXPERIMENTAL

Patients will have hypnosis add-on local anesthesia

Procedure: hypnosis

Examination under local anesthesia

NO INTERVENTION

Patients will receive a local anesthesia only without hypnosis

Interventions

hypnosis PROCEDURE

It will be proposed to the patient to participate in a study to assess the tolerance of Examination under hypnosis The examination is then conducted in endoscopy room. 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 form tolerance of the review

Examination under hypnosis in addition to local anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Respiratory System Abnormalities

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Stephane JOUVESHOMME

  Groupe Hospitalier Paris Saint-Joseph (FRANCE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 17, 2016
• Study Start: July 4, 2014
• Primary Completion: February 2, 2021
• Study Completion: December 31, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)