Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02775630 |
| Other study ID # |
FIBRO HYPNOSE |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 4, 2014 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Groupe Hospitalier Paris Saint Joseph |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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:
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.
Methodology :
DESIGN:
Number of subjects required: 126
The prevalence of poor tolerance of the examination in this population was 52% (numeric scale
of the overall tolerance> 3) and the expected objective in the intervention group under
hypnosis is a halving of the number of patients with EN > 3 to the overall safety, the number
of subjects to be included is 63 per group.
Time study: baseline in January 2015 for an expected period of eight months depending on the
pace of inclusion estimated to average 4 per week.
Randomization:
Randomization in the 2 groups will be made by day of the week carries the hypnotherapist
(Monday or Tuesday with a random alternation between these 2 days). The list of days will be
balanced by randomly alternating blocks. The team of bronchoscopy and prescribers of the
bronchoscopy will not be informed of the first schedule to avoid selection bias of patients.
Acquisition of data:
- Gender, age
- respiratory history
- bronchial endoscopy antecedent
- Admission Status (external or hospitalized)
- analgesic and anxiolytic Processing
- Anxiety Questionnaire HAD (Hospital Anxiety and Depression Scale)
- Pre-medication received
- vital parameters before and after the examination: heart rate, oxygen saturation
- Way passage of the endoscope (nose or mouth)
- Time of endoscopy (between the input and the output of the endoscopy suite)
- Quantity Xylocaine used during the exam
- Sampled
- Score cough, pain and overall tolerance of the digital scale review (self-evaluation by
the patient)
- Acceptance or not the patient to repeat the examination under the same conditions if his
health required in the future
- Straight-evaluation by the physician endoscopist of the overall tolerance of the review
by the patient (digital scale)
- Easy to complete the review by the endoscopist (digital scale)
- Summary of potential adverse events
Statistical analysis:
To find and test differences, univariate analyzes will use the test t-Student for continuous
variables and the chi of 2 for categorical variables or their nonparametric equivalents. The
significance level was set at p <0.05.
1.2 Serious Adverse Event (SAE)
A serious event is an event:
- The evolution of which is fatal; or
- Which endangers the life of the person undergoing research; or
- Which causes a disability or a significant or lasting disability; or
- Causing hospitalization or prolongation of hospitalization; or
- Which results in an abnormality or birth defect; or
- Any other event does not meet the qualifications listed above, but can be regarded as
"potentially serious" including some laboratory abnormalities; or
- Medically relevant event in the judgment of the investigator; or
- Events requiring medical intervention to prevent progression to one of the
aforementioned states.
The term "life-threatening" is reserved for immediate life-threatening at the time of the
adverse event, regardless of the consequences of corrective or palliative therapy.
Certain circumstances requiring hospitalization are not within the gravity standard
"inpatient / hospitalization extension" as:
admission for social or administrative reasons; hospitalization predefined by the protocol;
hospitalization for medical or surgical treatment scheduled prior research; passing day
hospital.
2. detection methods and collection of adverse events:
All adverse events should be investigated, reported and recorded, processed and evaluated the
first visit (inclusion Day 0) until the end of the study until their resolution.
Adverse events are collected:
- In clinical, biological and other planned and systematic examination by the
investigator;
- By spontaneous reporting by the participants, who will be instructed to contact the
investigating doctor in case of adverse events.
All adverse events will be recorded on forms on adverse events of case report form (see
Appendix 6). Each observed adverse events will be recorded individually. The intensity of
adverse events will be determined as follows:
- Mild (grade 1): no interference on the patient's daily activities;
- Moderate (grade 2): Moderate interference on the patient's daily activities but still
acceptable;
- Severe (grade 3) significant interference on the patient's daily activity and
unacceptable;
- Threat of life-threatening (grade 4);
- Death (Grade 5). All adverse events must be graded. Responsibilities of the investigator
2.1 Statement of SAEs
The investigator evaluates each adverse event in relation to its severity. The investigator
must notify by fax (01 44 12 32 52) to the sponsor (CRC GHPSJ) without delay after the day he
heard, all serious adverse events in the trial, except from those identified in the protocol
as not requiring immediate reporting. This initial notification is the subject of a written
report must be followed if necessary by one or the report (s) Additional (s) writing (s) Main
(s) within 8 days of the first declaration.
The investigator must document the best event (thanks to copies of laboratory results or
reports of examinations or hospitalization accounts informing the serious event, including
relevant negative results, not forgetting to make these documents and anonymous to register
number and the patient's code), medical diagnosis and a causal link between serious adverse
events and research.
The statement is sent to the developer with the serious adverse event reporting form signed
and dated.
The investigator should follow the patient with an SAE to its resolution, stabilization at a
level deemed acceptable by the investigator or return to the previous state, even if the
patient is out of the test and inform the promoter (CRC GHPSJ) fax: 01 44 12 32 52 using the
form (check: monitoring).
2.2 Assessment of causality
The investigator should assess causality of adverse events with research. The causal link is
binary (connected / not connected).
2.3 Reporting period and followed the terms of adverse events
The investigator should report serious adverse events from the inclusion of the patient until
the end of the experimental procedure.
The investigator should monitor adverse events until resolution or stabilization even if the
patient is out of the study.
2.4 Special Cases
2.4.1 Serious Events not immediately declare
To the extent it is expected no serious adverse event related to the participation of
patients in this study and that only certain serious adverse events known to be associated
with bronchoscopy (hemoptysis, asthma, respiratory distress, allergic xylocaine etc.) may
occur, they do not require immediate notification in accordance with the health authorities.
3. Responsibilities of the promoter
The Promoter will declare to ANSM and the CPP in accordance with the law of 9 August 2004:
- all unexpected serious adverse reactions without delay and at the latest within seven
calendar days from the day when the sponsor becomes aware of, and within 7 days for
monitoring,
- developments without delay safety and at the latest within 7 calendar days, and within 7
days for monitoring,
- annual safety reports within 60 calendar days of the anniversary date of the study.
4. Appointment of an independent monitoring committee
To the extent it is expected no serious adverse event related to the participation of
patients in this study, Investigators do not want to establish an independent monitoring
committee.
