Patient With Bronchial EndoscopyHypnoFibroNCT03703960
Contribution of Hypnotic Analgesia to Local Anesthesia During Bronchial Endoscopy.
A study testing hypnotic analgesia and music in people with Patient With Bronchial Endoscopy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Bronchial endoscopy (or bronchial fibroscopy) is an invasive diagnostic examination performed extremely frequently in the Pneumology department of the Dijon University Hospital, with an average of 1200 procedures per year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient With Bronchial Endoscopy
- What is being tested?
- hypnotic analgesia and music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2018to 25 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Person who has given oral consent
- Patient having:
- a bronchial endoscopy for diagnostic purposes,
- performed on schedule in the Pneumology Department and Intensive Respiratory Care at the Dijon University Hospital
- regardless of the indication or samples taken during the examination (simple exploration, lavage, biopsies)
Who cannot join
- Person not affiliated to a national health insurance system
- Person subject to legal protection (curatorship, guardianship)
- Person under judiciary protection
- Non-menopausal woman
- Adult unable or unwilling to consent
- Minor
Show all 11Show fewer
- Patient who does not speak French
- Patient with severe hearing disorder that make it difficult to perform hypnosis under good conditions
- Patient with psychiatric or neurological disorders such as dementia, psychosis or profound mental retardation
- Severe COPD requiring long-term oxygen therapy at home or with a tracheotomy
- Patient undergoing bronchial endoscopy for the management of acute respiratory distress
Trial locations and contacts
1 site in 1 country.
About this study
Bronchial endoscopy (or bronchial fibroscopy) is an invasive diagnostic examination performed extremely frequently in the Pneumology department of the Dijon University Hospital, with an average of 1200 procedures per year. It allows the pneumologist to see the first divisions of the bronchial tree but also to take samples for microbiological or anatomopathological purposes. The two main sampling techniques are bronchoalveolar lavage and endobronchial biopsies. Two steps in the process can be unpleasant for the patient:
- the crossing of the nasopharynx because of the narrow and curving passage,
- the crossing of the vocal cords and exploration of the trachea, which sometimes causes nausea but especially a cough and a feeling of suffocation.
Read more
Depending on the patients, the experience of the examination can be very difficult. In addition, the experience of the examination is influenced by the psychological state of the patient, who is often anxious in the perspective of a diagnosis of a malignancy. It is therefore recommended to perform this examination under local anesthesia (LA) with xylocaine spray 5%. Several protocols, such as the use of atropine, hydroxyzine or benzodiazepines, have been proposed to improve test tolerance, but no pre-medication, other than the drugs indicated in general anesthesia, including midazolam and propofol, has demonstrated their efficacy. Moreover, these molecules are not without respiratory side effects.
Several recent studies have suggested that hypnotic analgesia improves the experience and course of diagnostic procedures that are quite similar to bronchial endoscopy and are usually performed with LA. This is particularly the case for gastroscopy or trans-oesophageal ultrasound. In addition, the effectiveness of hypnotic analgesia for the relief of acute or chronic pain is increasingly well established in the literature. However, the pathophysiology of dyspnea is close to that of pain.
The hypothesis is that adding hypnotic analgesia to the usual local anesthesia will relieve the dyspnea and pain experienced during the examination. There are no studies or data yet on the effect of hypnotic analgesia in bronchial endoscopy with LA. The objective of this work is to demonstrate its effectiveness in order to potentially offer this intervention to all patients and to improve the management of this procedure.
- Conditions
- Patient With Bronchial Endoscopy
- Being tested
- hypnotic analgesia, music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnotic analgesiaOther
classic three-step hypnosis procedure (induction, trance and return to consciousness).
musicOther
calm music conducive to relaxation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 "Hypnosis" | Experimental | Not described Receives: Other: hypnotic analgesia |
| Group 2 "music" | Active comparator | Not described Receives: Other: music |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
score for the sensory component of dyspnea
Comparison of the evolution of the score assigned to the sensory component of dyspnea measured by the Multidimensional Dyspnea Profile (MDP) scale before and after bronchial endoscopy between patients of the interventional arm 1 under local anesthesia and hypnotic analgesia, patients of the interventional arm 2 under local anesthesia and relaxing music and patients of the control arm under LA bronchial endoscopy.
Measured: through study completion, an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start10 Dec 2018
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient With Bronchial EndoscopyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703960
- Sponsor's protocol ID
- GEORGES ADEMPU 2018
- Acronym
- HypnoFibro
- Status last verified
- Sep 2023
- First submitted
- 8 Oct 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Hypnotic Analgesia to Local Anesthesia During Bronchial Endoscopy.
- ClinicalTrials.gov ID
- NCT03703960
- Acronym / sponsor ID
- HypnoFibro / GEORGES ADEMPU 2018
- Conditions
- Patient With Bronchial Endoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bronchial endoscopy (or bronchial fibroscopy) is an invasive diagnostic examination performed extremely frequently in the Pneumology department of the Dijon University Hospital, with an average of 1200 procedures per year. It allows the pneumologist to see the first divisions of the bronchial tree but also to take samples for microbiological or anatomopathological purposes. The two main sampling techniques are bronchoalveolar lavage and endobronchial biopsies. Two steps in the process can be unpleasant for the patient:
- the crossing of the nasopharynx because of the narrow and curving passage,
- the crossing of the vocal cords and exploration of the trachea, which sometimes causes nausea but especially a cough and a feeling of suffocation.
Depending on the patients, the experience of the examination can be very difficult. In addition, the experience of the examination is influenced by the psychological state of the patient, who is often anxious in the perspective of a diagnosis of a malignancy. It is therefore recommended to perform this examination under local anesthesia (LA) with xylocaine spray 5%. Several protocols, such as the use of atropine, hydroxyzine or benzodiazepines, have been proposed to improve test tolerance, but no pre-medication, other than the drugs indicated in general anesthesia, including midazolam and propofol, has demonstrated their efficacy. Moreover, these molecules are not without respiratory side effects.
Several recent studies have suggested that hypnotic analgesia improves the experience and course of diagnostic procedures that are quite similar to bronchial endoscopy and are usually performed with LA. This is particularly the case for gastroscopy or trans-oesophageal ultrasound. In addition, the effectiveness of hypnotic analgesia for the relief of acute or chronic pain is increasingly well established in the literature. However, the pathophysiology of dyspnea is close to that of pain.
The hypothesis is that adding hypnotic analgesia to the usual local anesthesia will relieve the dyspnea and pain experienced during the examination. There are no studies or data yet on the effect of hypnotic analgesia in bronchial endoscopy with LA. The objective of this work is to demonstrate its effectiveness in order to potentially offer this intervention to all patients and to improve the management of this procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 "Hypnosis" | Experimental | Other: hypnotic analgesia |
| Group 2 "music" | Active comparator | Other: music |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Person who has given oral consent
- Patient having:
Key exclusion criteria (11 listed)
- Person not affiliated to a national health insurance system
- Person subject to legal protection (curatorship, guardianship)
- Person under judiciary protection
- Non-menopausal woman
- Adult unable or unwilling to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypnotic analgesiaclassic three-step hypnosis procedure (induction, trance and return to consciousness). | Other | Group 1 "Hypnosis" |
| musiccalm music conducive to relaxation | Other | Group 2 "music" |
Primary outcome
score for the sensory component of dyspnea
Time frame: through study completion, an average of 30 minutes
Comparison of the evolution of the score assigned to the sensory component of dyspnea measured by the Multidimensional Dyspnea Profile (MDP) scale before and after bronchial endoscopy between patients of the interventional arm 1 under local anesthesia and hypnotic analgesia, patients of the interventional arm 2 under local anesthesia and relaxing music and patients of the control arm under LA bronchial endoscopy.
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypnotic analgesia and music in people with Patient With Bronchial Endoscopy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score for the sensory component of dyspnea (time frame: through study completion, an average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.