Difficult Mechanical Ventilation WeaningEasy WeanNCT06926231
Non-medicinal Technique and Dyspnea in Weaning Patients
A study testing Protocolized medical hypnosis in people with Difficult Mechanical Ventilation Weaning and Spontaneous Breathing Trial, run by Hospices Civils de Lyon at 5 sites in France.
Trial summary
This is a randomized, controlled, multicenter, open-label, category 2, parallel-arm study of efficacy and superiority. The target population are patients hospitalized in the intensive care unit (ICU), ventilated with invasive mechanical ventilation for 24 hours or more and having failed a spontaneous breathing trial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Mechanical Ventilation Weaning, Spontaneous Breathing Trial, Dyspnea
- What is being tested?
- Protocolized medical hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Jun 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patient
- hospitalized in the intensive care unit
- receiving invasive mechanical ventilation for 24 hours or more.
- who has failed at least one spontaneous breathing trial
Who cannot join
- Patient already intubated during current ICU stay (including transfer from another ICU unit), with successful extubation during stay.
- Tracheostomized patient or patient with a short-term tracheostomy project.
- Patients with chronic neuromuscular pathologies (myopathy, amyotrophic lateral sclerosis, multi-system atrophy, non-exhaustive list).
- Patient no longer eligible for SBT at time of inclusion (hemodynamic, neurological or respiratory criterion)
- Psychiatric pathology identified in the medical record, diagnosed by a psychiatrist and for which medication is prescribed (bipolar disorder, schizophrenia, anxiety-depressive disorder, non-exhaustive list).
- Recent brain injury, within < 3 months (stroke, cardiopulmonary arrest with neurological prognosis, non-exhaustive list) objectivated by medical imagery.
Show all 20Show fewer
- Cognitive impairment or delirium associated with resuscitation, identified by a positive CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) test (dynamic parameter).
- Ocular Glasgow score lower than 4/4 and motor response lower than response to simple commands.
- Delirium tremens with Cushman score > 7 (dynamic parameter).
- Language barrier, patient who does not use French in everyday life.
- Deaf or hearing-impaired patients.
- Re-sedated patient following the failed SBT the day before inclusion.
- Pregnant, parturient or breastfeeding women, objectified by a negative pregnancy test in women of childbearing age.
- Patient for whom a limitation of therapeutics has been decided, including the absence of a re-intubation project.
- Patient whose consent cannot be obtained (directly or in front of a relative or witness).
- Patient already included in the same study or in another study sharing the same primary outcome.
- Patient deprived of liberty by judicial or administrative decision.
- Patient of legal age under legal protection (guardianship, curators).
- Patient not affiliated to a social security system or beneficiary of a similar system.
- Patient participating in another interventional research study with an exclusion period still in effect at pre-inclusion.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites
Hôpital de Fleyriat - Centre hospitalier de Bourg-en-Bresse - Réanimation Soins continus
Bourg-en-Bresse, 01012
Caroline REVOL, Registered Nurse, + 33 474454230, crevol@ch-bourg01.fr
CHU Clermont Ferrand - Hôpital Gabriel Montpied - Médecine Intensive Réanimation
Clermont-Ferrand, 6300
Edouard DUGAT, Medical doctor, +33 4 73 75 18 57, edugat@chu-clermontferrand.fr
CHU Grenoble Alpes - Hôpital Michallon - Médecine Intensive Réanimation
La Tronche, 38700
Prescillia GAMON, Registered Nurse, +33 4 76 76 71 09, pgamon@chu-grenoble.fr
Hospices Civils de Lyon - Hôpital de la Croix Rousse - Médecine Intensive Réanimation
Lyon, 69004
Christelle TOMBALIAN, Registered Nurse, + 33 4 26 10 92 65, ghn.easywean@chu-lyon.fr
Hospices Civils de Lyon - Hôpital Lyon Sud - Réanimation Polyvalente
Pierre-Bénite, 69495
Anaelle CAILLET, Registered Nurse, anaelle.caillet@chu-lyon.fr
About this study
Official title: Impact of a Non-medicinal Technique Medical Hypnosis on Perceived Dyspnea in Difficult Ventilatory Weaning Patients: a Multicenter Randomized Controlled Trial.
This is a randomized, controlled, multicenter, open-label, category 2, parallel-arm study of efficacy and superiority.
The target population are patients hospitalized in the intensive care unit (ICU), ventilated with invasive mechanical ventilation for 24 hours or more and having failed a spontaneous breathing trial (SBT, i.e. weaning test of invasive mechanical ventilation [IMV]).
Read more
The primary objective is to evaluate the efficacy of medical hypnosis in reducing dyspnea experienced before the SBT in patients identified as difficult to wean in the ICU, compared with the protocolized standard of care.
The primary outcome is the mean value of the daily visual analog scale (VAS) of dyspnea, self-assessed by the patient, measured immediately after the hypnosis session (before SBT) from Day-0 to Day-7 or until extubation. In the control group, the daily value (from D0 to D7 or extubation) of the self-assessed dyspnea VAS will be measured immediately before SBT.
The protocol will be divided into two arms: a control arm in which standard of care practices regarding the daily SBT will be protocolized, and an interventional arm in which patients will receive protocolized medical hypnosis before the daily SBT in addition to the protocolized standard of care. The intervention (hypnosis or control) will be performed daily for 7 days (or until extubation, if applicable). The primary outcome will be assessed daily over the same period.
- Being tested
- Protocolized medical hypnosis, Protocolized standard of care
- Keywords
- difficult mechanical ventilation weaning, dyspnea, mechanical ventilation, spontaneous breathing trial, hypnosis
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolized medical hypnosisBehavioural
Patients who will receive protocolized medical hypnosis before the SBT every day between inclusion and day 7. Medical hypnosis sessions will consist in the administration of a 5-min hypnotic text by a loudspeaker installed in the ICU room, after selection of a hypnotic theme (sea, mountain or animals) by the participant. The hypnosis session will involve an induction phase, a suggestion phase and an emergence phase, along with self-hypnosis tips. The hypnosis session will immediately precede the SBT (<2h). The intervention is administered before the SBT daily from the randomization to day 7 or until extubation.
Protocolized standard of careBehavioural
The protocolized standard of care will consist in the description of authorized human/behavioral patient-nurse interactions and patient installation prior to the daily SBT.
| Study group | Role | What they receive |
|---|---|---|
| Medical hypnosis | Experimental | Patients who will receive protocolized medical hypnosis before the SBT every day between inclusion and day-7. Medical hypnosis sessions will consist in the administration of a 5-min hypnotic text by a loudspeaker installed in the ICU room, after selection of a hypnotic theme (sea, mountain or animals) by the participant. The hypnosis session will involve an induction phase, a suggestion phase and an emergence phase, along with self-hypnosis tips. The hypnosis session will immediately precede the SBT (<2h). The intervention is administered before the SBT daily from the randomization to day 7 or until extubation. Receives: Behavioral: Protocolized medical hypnosis |
| Standard of care | Active comparator | Patients who will receive protocolized standard of care (without medical hypnosis) before the SBT, every day between inclusion and day 7. Receives: Behavioral: Protocolized standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean value of self-reported daily visual analog scale of dyspnea after the intervention or the control strategy
Mean value of self-reported daily visual analog scale (VAS) of dyspnea, measured immediately after the hypnosis session (before SBT) from day 0 to day 7 or until extubation. In the control group, the daily value (from day 0 to day 7 or extubation) of self-reported VAS of dyspnea will be measured immediately before SBT. The outcome measure consists in the mean value of the daily measures collected during this period.
Measured: Immediately after the hypnosis session (before SBT) from day 0 to day 7 or until extubation. In the control group, the daily value (from day 0 to day 7 or extubation) of self-reported VAS of dyspnea will be measured immediately before SBT.
Secondary outcomes (14)
Mean MV-RDOS score (Mechanical Ventilation-Respiratory Distress Observation Scale) after the intervention or the control strategy
The outcome is a scale evaluating respiratory distress assessed by the treating team, as a reliable surrogate of self-reported dyspnea in non-communicative intubated patients The minimum and maximum values are 0 and 16. An RDOS score of less than 3 indicates respiratory comfort; An RDOS score greater than or equal to 3 signifies respiratory distress and need for palliation Higher RDOS scores signify a worsening condition The outcome measure consists in the mean value of the daily measures collected during this period.
Measured: Immediately after the hypnosis session (before SBT) from day 0 to day 7 or until extubation. In the control group, the daily value (from day 0 to day 7 or extubation) of MV-RDOS will be measured immediately before SBT.
Mean VAS of dyspnea at the end of the SBT
Mean value of self-reported daily visual analog scale (VAS) of dyspnea, measured immediately after the hypnosis session (before SBT) from day 0 to day 7 or until extubation. In the control group, the daily value (from day 0 to day 7 or extubation) of self-reported VAS of dyspnea will be measured immediately before SBT.
The SBT protocol lasts 30 minutes at the end of which the dyspnea VAS will be evaluated.
The outcome measure consists in the mean value of the daily measures collected during this period.
Measured: Immediately at the end of the daily protocolized SBT, which is performed every day from day 0 to day 7 or until extubation in all patients. Measured daily at the end of the SBT, from day 0 to day 7 or until extubation. Up to 28 days
Mean MV-RDOS at the end of SBT
The outcome is a scale evaluating respiratory distress assessed by the treating team, as a reliable surrogate of self-reported dyspnea in non-communicative intubated patients The minimum and maximum values are 0 and 16. An RDOS score of less than 3 indicates respiratory comfort; An RDOS score greater than or equal to 3 signifies respiratory distress and need for palliation Higher RDOS scores signify a worsening condition The SBT protocol lasts 30 minutes at the end of which the MV-RDOS will be evaluated.
The outcome measure consists in the mean value of the daily measures collected during this period.
Measured: Immediately at the end of the daily protocolized SBT, which is performed every day from day 0 to day 7 or until extubation in all patients.
Mean VAS of anxiety at the end of SBT
Mean value of self-reported daily visual analog scale (VAS) of anxiety, measured immediately after the hypnosis session (before SBT) from day 0 to day 7 or until extubation. In the control group, the daily value (from day 0 to day 7 or extubation) of self-reported VAS of anxiety will be measured immediately before SBT.
The SBT protocol lasts 30 minutes at the end of which the anxiety VAS will be evaluated. The outcome measure consists in the mean value of the daily measures collected during this period.
Measured: Immediately at the end of the daily protocolized SBT, which is performed every day from day 0 to day 7 or until extubation in all patients.
Mean VAS of pain at the end of SBT
Mean value of self-reported daily visual analog scale (VAS) of pain, measured immediately after the hypnosis session (before SBT) from day 0 to day 7 or until extubation. In the control group, the daily value (from day 0 to day 7 or extubation) of self-reported VAS of pain will be measured immediately before SBT.
The SBT protocol lasts 30 minutes at the end of which the pain VAS will be evaluated.
Measured: Immediately at the end of the daily protocolized SBT, which is performed every day from Day 0 to Day 7 or until extubation in all patients. The outcome measure consists in the mean value of the daily measures collected during this period.
Respiratory physiology
Respiratory rate (in bpm, beats per minute) and O2 percutaneous saturation (in %)
Measured: Value of respiratory rate and SpO2, measured immediately at the beginning of the SBT, and worst value observed during the daily SBT, between inclusion and day 7 or extubation
Hemodynamic status
Heart rate (in bpm) and mean arterial pressure (in mmHg / millimetre of mercury)
Measured: Value of heart rate and mean arterial pressure, measured immediately at the beginning of the SBT, and worst value observed during the daily SBT, between inclusion and day 7 or extubation
Quality of applied intervention and control strategies
Rate of medical hypnosis sessions and standard of care sessions in each group achieving predefined quality criteria. Predefined quality criteria are: interruption, quality of the interaction, duration of the intervention, impossibility to apply the strategy, adverse event
Measured: Up to Day 7
Feasibility: enrolment
Number of subjects included divided by total number of eligible subjects
Measured: At the end of the study recruitment.
Feasibility: hypnosis training
Number of hypnosis training sessions for paramedics of participating centers actually carried out in participating centers during the study.
Measured: At the end of the recruitment.
Safety: neurological impact of strategies
Highest value of the Richmond Agitation Sedation Scale (-5 to +4) observed daily during the hypnosis session or control intervention.
Measured: The RASS value will be assessed continuously during the duration of the intervention in Gp1 or during the protocolized observation period in Gp2, and its highest value will be reported. It will be reported daily in each group, between inclusion and D7.
Invasive mechanical ventilation weaning
Ventilator free days (VFD) : number of days alive without invasive mechanical ventilation, between the date of last successful extubation and day 28. A score of 0 is allocated in case of death between inclusion and day 28.
Measured: Measured at day 28
Reintubation
Rate of reintubation within 7 days of extubation, until day 28.
Measured: Measured at day 28
ICU length of stay
Number of days between randomization and ICU discharge.
Measured: through study completion, up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Mechanical Ventilation WeaningStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926231
- Sponsor's protocol ID
- 69HCL24_0209
- Other IDs
- ID-RCB
- Acronym
- Easy Wean
- Status last verified
- Apr 2025
- First submitted
- 19 Mar 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Non-medicinal Technique Medical Hypnosis on Perceived Dyspnea in Difficult Ventilatory Weaning Patients: a Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06926231
- Acronym / sponsor ID
- Easy Wean / 69HCL24_0209
- Keywords
- difficult mechanical ventilation weaning, dyspnea, mechanical ventilation, spontaneous breathing trial, hypnosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 13 Apr 2025 (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.
This is a randomized, controlled, multicenter, open-label, category 2, parallel-arm study of efficacy and superiority.
The target population are patients hospitalized in the intensive care unit (ICU), ventilated with invasive mechanical ventilation for 24 hours or more and having failed a spontaneous breathing trial (SBT, i.e. weaning test of invasive mechanical ventilation [IMV]).
The primary objective is to evaluate the efficacy of medical hypnosis in reducing dyspnea experienced before the SBT in patients identified as difficult to wean in the ICU, compared with the protocolized standard of care.
The primary outcome is the mean value of the daily visual analog scale (VAS) of dyspnea, self-assessed by the patient, measured immediately after the hypnosis session (before SBT) from Day-0 to Day-7 or until extubation. In the control group, the daily value (from D0 to D7 or extubation) of the self-assessed dyspnea VAS will be measured immediately before SBT.
The protocol will be divided into two arms: a control arm in which standard of care practices regarding the daily SBT will be protocolized, and an interventional arm in which patients will receive protocolized medical hypnosis before the daily SBT in addition to the protocolized standard of care. The intervention (hypnosis or control) will be performed daily for 7 days (or until extubation, if applicable). The primary outcome will be assessed daily over the same period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical hypnosis | Experimental | Behavioral: Protocolized medical hypnosisPatients who will receive protocolized medical hypnosis before the SBT every day between inclusion and day-7. Medical hypnosis sessions will consist in the administration of a 5-min hypnotic text by a loudspeaker installed in the ICU room, after selection of a hypnotic theme (sea, mountain or animals) by the participant. The hypnosis session will involve an induction phase, a suggestion phase and an emergence phase, along with self-hypnosis tips. The hypnosis session will immediately precede the SBT (<2h). The intervention is administered before the SBT daily from the randomization to day 7 or until extubation. |
| Standard of care | Active comparator | Behavioral: Protocolized standard of carePatients who will receive protocolized standard of care (without medical hypnosis) before the SBT, every day between inclusion and day 7. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient
- hospitalized in the intensive care unit
- receiving invasive mechanical ventilation for 24 hours or more.
- who has failed at least one spontaneous breathing trial
Key exclusion criteria (20 listed)
- Patient already intubated during current ICU stay (including transfer from another ICU unit), with successful extubation during stay.
- Tracheostomized patient or patient with a short-term tracheostomy project.
- Patients with chronic neuromuscular pathologies (myopathy, amyotrophic lateral sclerosis, multi-system atrophy, non-exhaustive list).
- Patient no longer eligible for SBT at time of inclusion (hemodynamic, neurological or respiratory criterion)
- Psychiatric pathology identified in the medical record, diagnosed by a psychiatrist and for which medication is prescribed (bipolar disorder, schizophrenia, anxiety-depressive disorder, non-exhaustive list).
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 |
|---|---|---|
| Protocolized medical hypnosisPatients who will receive protocolized medical hypnosis before the SBT every day between inclusion and day 7. Medical hypnosis sessions will consist in the administration of a 5-min hypnotic text by a loudspeaker installed in the ICU room, after selection of a hypnotic theme (sea, mountain or animals) by the participant. The hypnosis session will involve an induction phase, a suggestion phase and an emergence phase, along with self-hypnosis tips. The hypnosis session will immediately precede the SBT (<2h). The intervention is administered before the SBT daily from the randomization to day 7 or until extubation. | Behavioural | Medical hypnosis |
| Protocolized standard of careThe protocolized standard of care will consist in the description of authorized human/behavioral patient-nurse interactions and patient installation prior to the daily SBT. | Behavioural | Standard of care |
Primary outcome
Mean value of self-reported daily visual analog scale of dyspnea after the intervention or the control strategy
Time frame: Immediately after the hypnosis session (before SBT) from day 0 to day 7 or until extubation. In the control group, the daily value (from day 0 to day 7 or extubation) of self-reported VAS of dyspnea will be measured immediately before SBT.
Mean value of self-reported daily visual analog scale (VAS) of dyspnea, measured immediately after the hypnosis session (before SBT) from day 0 to day 7 or until extubation. In the control group, the daily value (from day 0 to day 7 or extubation) of self-reported VAS of dyspnea will be measured immediately before SBT. The outcome measure consists in the mean value of the daily measures collected during this period.
14 secondary outcomes
Mean MV-RDOS score (Mechanical Ventilation-Respiratory Distress Observation Scale) after the intervention or the control strategy
Time frame: Immediately after the hypnosis session (before SBT) from day 0 to day 7 or until extubation. In the control group, the daily value (from day 0 to day 7 or extubation) of MV-RDOS will be measured immediately before SBT.
Mean VAS of dyspnea at the end of the SBT
Time frame: Immediately at the end of the daily protocolized SBT, which is performed every day from day 0 to day 7 or until extubation in all patients. Measured daily at the end of the SBT, from day 0 to day 7 or until extubation. Up to 28 days
Mean MV-RDOS at the end of SBT
Time frame: Immediately at the end of the daily protocolized SBT, which is performed every day from day 0 to day 7 or until extubation in all patients.
Mean VAS of anxiety at the end of SBT
Time frame: Immediately at the end of the daily protocolized SBT, which is performed every day from day 0 to day 7 or until extubation in all patients.
Mean VAS of pain at the end of SBT
Time frame: Immediately at the end of the daily protocolized SBT, which is performed every day from Day 0 to Day 7 or until extubation in all patients. The outcome measure consists in the mean value of the daily measures collected during this period.
Respiratory physiology
Time frame: Value of respiratory rate and SpO2, measured immediately at the beginning of the SBT, and worst value observed during the daily SBT, between inclusion and day 7 or extubation
Hemodynamic status
Time frame: Value of heart rate and mean arterial pressure, measured immediately at the beginning of the SBT, and worst value observed during the daily SBT, between inclusion and day 7 or extubation
Quality of applied intervention and control strategies
Time frame: Up to Day 7
Feasibility: enrolment
Time frame: At the end of the study recruitment.
Feasibility: hypnosis training
Time frame: At the end of the recruitment.
Safety: neurological impact of strategies
Time frame: The RASS value will be assessed continuously during the duration of the intervention in Gp1 or during the protocolized observation period in Gp2, and its highest value will be reported. It will be reported daily in each group, between inclusion and D7.
Invasive mechanical ventilation weaning
Time frame: Measured at day 28
Reintubation
Time frame: Measured at day 28
ICU length of stay
Time frame: through study completion, up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
Related trials for Difficult Mechanical Ventilation Weaning
Recruiting
Diaphragmatic Ultrasonography in Difficult Weaning
Weaning Mechanical Ventilation, ICU Ill Patients
Recruiting
Improving Our Understanding of Respiratory Muscle Training to Facilitate Weaning From Mechanical Ventilation in the ICU
Weaning Failure
Recruiting
Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients
Ventilator Weaning
RecruitingObservational study
Role of Regional Lung Compliance and Dynamic Transpulmonary Driving Pressure in the Liberation Difficulty in Tracheostomized Patients Receiving Prolonged Mechanical Ventilation
Weaning Failure
Recruiting
Muscle Recruitment During Neck Flexion and Inspiratory Muscle Training
Mechanical Ventilator Weaning, Respiratory Muscle Training
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocolized medical hypnosis in people with Difficult Mechanical Ventilation Weaning and Spontaneous Breathing Trial, run by Hospices Civils de Lyon at 5 sites 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 4 inclusion and 20 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: opening soon, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle TOMBALIAN (+ 33 4 26 10 92 65, ghn.easywean@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean value of self-reported daily visual analog scale of dyspnea after the intervention or the control strategy (time frame: Immediately after the hypnosis session (before SBT) from day 0 to day 7 or until extubation. In the control group, the daily value (from day 0 to day 7 or extubation) of self-reported VAS of dyspnea will be measured immediately before SBT.). 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 23 May 2025.