TracheotomyHYPNO-TRACHNCT02977767
Evaluation of the Effect of Conversational Hypnosis When Changing Tracheal Cannula in Adult Patients
A study testing Conversational hypnosis in people with Tracheotomy, run by Centre Hospitalier Universitaire de la Réunion.
Trial summary
Tracheotomy is requested when upper aero-digestive tracts are obstructed. This obstruction can have a tumour, infectious, inflammatory, traumatic or nervous origin. Most tracheotomy surgeries are performed for tumour-induced obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheotomy
- What is being tested?
- Conversational hypnosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2018to Mar 2020
- 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
- patients hospitalised in the Ear, Nose, Throat - specialties surgery department
- aged of 18 years old and more
- having a tracheotomy following an upper aero-digestive tracts obstruction
- presenting a tracheal cannula which can be replaced by paramedical staff
- able to communicate to give their consent
- member or beneficiary of a social security assurance
- having given a signed informed consent form
Who cannot join
- patients presenting a hearing loss (preventing from hearing properly the words pronounced during conversational hypnosis)
- who do not understand French
- who are under curators/guardianship
- presenting dementia
- autonomous in their cannula replacement
- having already participated in the study
About this study
Official title: Evaluation of the Effect of Conversational Hypnosis When Changing Tracheal Cannula in Adult Patients: a Pilot Study
Tracheotomy is requested when upper aero-digestive tracts are obstructed. This obstruction can have a tumour, infectious, inflammatory, traumatic or nervous origin. Most tracheotomy surgeries are performed for tumour-induced obstruction. Tracheotomy allows the setting of a respiratory flux thanks to a cannula and excludes the upper airways. The cannula is washed every day from once to several times depending on the patient's secretions production and it is usually replaced every week. The second replacement takes place about 10 days after surgery. Patient education takes place at every replacement in order to empower him/her and in consequence to increase living comfort. This empowerment is achieved at the 4th or 5th replacement, at best. Because of the risks and complications related to tracheotomy and because of the concerned vital function, the cannula replacement leads to anxiety especially during the first replacements. Usual patient's anxiety management consists in reassuring the patient during the replacement. In other situations, patients' anxiety management would be drugs, however due to sedative and anxiolytic drugs' adverse events and to the need to maintain optimal breathing, they are not used in first intention. Our choice is to use conversational hypnosis during cannula replacement as it has already demonstrated interesting effects in pain and anxiety. Conversational hypnosis does not present an induction phase like in so-called hypnosis, it aims at leading the patient to perceive his/her world differently with only a slight consciousness alteration.
Read the detailed description
Once the informed consent form is signed and when the cannula replacement has to be performed, conversational hypnosis session will start right from the patient's room entrance and end when the nurse will come out. The care will consist in aspiration, cleaning and finally replacement of the cannula. Adverse events are expected to be related to the cannula replacement itself: patients will be followed-up during a maximum of 7 days with one follow-up visit which will take place 2 hours after cannula replacement and a second one which can take place from the day after the replacement up to just before the following replacement.
- Conditions
- Tracheotomy
- Being tested
- Conversational hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversational hypnosisProcedure or surgery
Conversational hypnosis starts since the enter of the nurse in patient's room and last since the nurse leaves the room. Change of canula is performed under conversational hypnosis.
| Study group | Role | What they receive |
|---|---|---|
| Conversational hypnosis | Experimental | Use of conversational hypnosis during the tracheal cannula replacement Receives: Procedure: Conversational hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to change the tracheal cannula using conversational hypnosis
Once the written informed consent form is obtained, the tracheal cannula change to perform in the frame of the study can be performed. As the patient will be scoped, the time to change the cannula will be monitored: the nurse will use an indicator on the scope to mark the start of the cannula change (when the sentence "now we start" is pronounced according to the conversational hypnosis protocol) and an indicator is placed on the scope when the new cannula is fixed around the patient's neck. The time between the two indicators will be reported in the Case Report Form in seconds.
Measured: On the patient's scope, time measured from the moment the nurse says "now we start" according to the conversational hypnosis protocol to the time the new cannula is fixed around the patient's neck, assessed up to 1 hour (3600 seconds).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start15 Nov 2018
- Primary completionNov 2019 (estimated)
- Study completionMar 2020 (estimated)
Why it stopped: Participants do not accept hypnosis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheotomyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daw-Horng WU, MD, Principal investigator, CHU La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977767
- Sponsor's protocol ID
- 2016/CHU/02
- Acronym
- HYPNO-TRACH
- Status last verified
- Jan 2024
- First submitted
- 23 Nov 2016
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Conversational Hypnosis When Changing Tracheal Cannula in Adult Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT02977767
- Acronym / sponsor ID
- HYPNO-TRACH / 2016/CHU/02
- Conditions
- Tracheotomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Participants do not accept hypnosis.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 30 Nov 2016 (estimated)
- 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.
Tracheotomy is requested when upper aero-digestive tracts are obstructed. This obstruction can have a tumour, infectious, inflammatory, traumatic or nervous origin. Most tracheotomy surgeries are performed for tumour-induced obstruction. Tracheotomy allows the setting of a respiratory flux thanks to a cannula and excludes the upper airways. The cannula is washed every day from once to several times depending on the patient's secretions production and it is usually replaced every week. The second replacement takes place about 10 days after surgery. Patient education takes place at every replacement in order to empower him/her and in consequence to increase living comfort. This empowerment is achieved at the 4th or 5th replacement, at best. Because of the risks and complications related to tracheotomy and because of the concerned vital function, the cannula replacement leads to anxiety especially during the first replacements. Usual patient's anxiety management consists in reassuring the patient during the replacement. In other situations, patients' anxiety management would be drugs, however due to sedative and anxiolytic drugs' adverse events and to the need to maintain optimal breathing, they are not used in first intention. Our choice is to use conversational hypnosis during cannula replacement as it has already demonstrated interesting effects in pain and anxiety. Conversational hypnosis does not present an induction phase like in so-called hypnosis, it aims at leading the patient to perceive his/her world differently with only a slight consciousness alteration.
Detailed description
Once the informed consent form is signed and when the cannula replacement has to be performed, conversational hypnosis session will start right from the patient's room entrance and end when the nurse will come out. The care will consist in aspiration, cleaning and finally replacement of the cannula. Adverse events are expected to be related to the cannula replacement itself: patients will be followed-up during a maximum of 7 days with one follow-up visit which will take place 2 hours after cannula replacement and a second one which can take place from the day after the replacement up to just before the following replacement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conversational hypnosis | Experimental | Procedure: Conversational hypnosisUse of conversational hypnosis during the tracheal cannula replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients hospitalised in the Ear, Nose, Throat - specialties surgery department
- aged of 18 years old and more
- having a tracheotomy following an upper aero-digestive tracts obstruction
- presenting a tracheal cannula which can be replaced by paramedical staff
- able to communicate to give their consent
Key exclusion criteria (6 listed)
- patients presenting a hearing loss (preventing from hearing properly the words pronounced during conversational hypnosis)
- who do not understand French
- who are under curators/guardianship
- presenting dementia
- autonomous in their cannula replacement
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 |
|---|---|---|
| Conversational hypnosisConversational hypnosis starts since the enter of the nurse in patient's room and last since the nurse leaves the room. Change of canula is performed under conversational hypnosis. | Procedure or surgery | Conversational hypnosis |
Primary outcome
Time to change the tracheal cannula using conversational hypnosis
Time frame: On the patient's scope, time measured from the moment the nurse says "now we start" according to the conversational hypnosis protocol to the time the new cannula is fixed around the patient's neck, assessed up to 1 hour (3600 seconds).
Once the written informed consent form is obtained, the tracheal cannula change to perform in the frame of the study can be performed. As the patient will be scoped, the time to change the cannula will be monitored: the nurse will use an indicator on the scope to mark the start of the cannula change (when the sentence "now we start" is pronounced according to the conversational hypnosis protocol) and an indicator is placed on the scope when the new cannula is fixed around the patient's neck. The time between the two indicators will be reported in the Case Report Form in seconds.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Tracheotomy
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
Enrolling by invitationObservational study
A Speaking-Valve-Based Decannulation Protoco for Patients With a Prolonged Disorders of Consciousness
Prolonged Disorders of Consciousness, Tracheostomy
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
Enrolling by invitation
No DIET Trial: Dogmatic Interruption of Enteral nuTrition
Gastrostomy, Tracheostomy
Recruiting
Classical Music, Pain, and Physiological Parameters in Children Undergoing Two Aspiration Procedures
Endotracheal Aspiration, Tracheostomy Patients
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.
Daw-Horng WU, MD principal investigator
CHU La Réunion
Questions about this trial
What is this clinical trial studying?
A study testing Conversational hypnosis in people with Tracheotomy, run by Centre Hospitalier Universitaire de la Réunion.
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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Time to change the tracheal cannula using conversational hypnosis (time frame: On the patient's scope, time measured from the moment the nurse says "now we start" according to the conversational hypnosis protocol to the time the new cannula is fixed around the patient's neck, assessed up to 1 hour (3600 seconds).). 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 8 Jan 2024.