Chronic Obstructive Pulmonary Disease (COPD)HYVIRNCT04220463
Interest of Hypnosis When Setting up Non-invasive Ventilation in a Conscious Patient With COPD and/or Obesity With a BMI Greater Than 30, Suffering Fromacute Respiratory Distress in Adult Intensive Care
A study testing Hypnosis + NIV and NIV in people with Chronic Obstructive Pulmonary Disease (COPD) and Obesity With a BMI Greater Than 30, run by Rennes University Hospital at 1 site in France.
Trial summary
Discomfort during respiratory decompensation of a patient with chronic obstructive pulmonary disease (COPD) and/or obesity with a BMI greater than 30, in intensive care and the establishment of non-invasive ventilation (NIV) is frequent and a source of failure. this therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Obesity With a BMI Greater Than 30, Acute Respiratory Distress in Adult Intensive Care
- What is being tested?
- Hypnosis + NIV and NIV
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2021to 20 Nov 2025
- 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
- Glasgow score = 15
- Need during use of non-invasive ventilation
Who cannot join
- Procedure to be carried out in extreme urgency (PaCO2 too high and leading to an immediate vital risk, and / or PaO2 too low) on medical decision
- Confusional state making hypnosis impossible
- Decompensated psychiatric illness
- Patient entering with an NIV in place already installed in another department. The subject becomes included again at the end of the treatment with NIV if however he needs it again.
- Patient already included in the study during previous non-invasive ventilation
- Patient participating in research involving an interventional human person (category 1) on an analgesic / sedative medication
- A person of full age subject to legal protection (safeguard of justice, curators, guardianship) or deprived of liberty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rennes University Hospital
Rennes, Brittany Region, 35033
Claude Faleur, nurse, 0299284321, claude.faleur@chu-rennes.fr
Violaine BENOIT, project leader, 0299289741, violaine.benoit@club-internet.fr
About this study
Official title: HYVIR : Interest of Hypnosis During the Implementation of Non-invasive Ventilation in a Patient With COPD and/or Obesity With a BMI Greater Than 30, Conscious With Acute Respiratory Distress in the Adult Intensive Care Unit
Discomfort during respiratory decompensation of a patient with chronic obstructive pulmonary disease (COPD) and/or obesity with a BMI greater than 30, in intensive care and the establishment of non-invasive ventilation (NIV) is frequent and a source of failure. this therapy. Pharmacological treatments may be impossible due to the pathology, the risk of it worsening and adverse effects. In this context, hypnosis appears to be a tool that would promote comfort and thus increase tolerance of NIV.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Obesity With a BMI Greater Than 30, Acute Respiratory Distress in Adult Intensive Care
- Being tested
- Hypnosis + NIV, NIV
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis + NIVOther
For the hypnosis group, hypnotic support is set up by a doctor/IDE previously trained and dedicated during the implementation of the NIV. The dedicated doctor/IDE will be presented before the start of the NIV setup procedure and will start the hypnosis session a few minutes before the mask is put on. The procedure for setting up the NAV may begin after agreement from the dedicated doctor/IDE.
NIVOther
In the control group, in order to preserve the knowledge of the evaluator, the doctor/IDE dedicated to hypnosis is present in the service but does not intervene in the care so as not to be tempted to involuntarily put hypnosis in place. The assessor will be chosen from the two other teams present in the other two modules (each module is a seven-bed unit and has no physical communication with the other two) after the start of the procedure for setting up the NIV, with or without hypnosis, in order to be certain that he had no visual contact with the patient and the caregivers present before the evaluation. The implementation of the NAV will take place as usually carried out in the service.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis group | Experimental | For the hypnosis group, hypnotic support is set up by a doctor/IDE previously trained and dedicated during the implementation of the NIV. The dedicated doctor/IDE will be presented before the start of the NIV setup procedure and will start the hypnosis session a few minutes before the mask is put on. The procedure for setting up the NAV may begin after agreement from the dedicated doctor/IDE. Receives: Other: Hypnosis + NIV |
| Control group | Placebo comparator | In the control group, in order to preserve the knowledge of the evaluator, the doctor/IDE dedicated to hypnosis is present in the service but does not intervene in the care so as not to be tempted to involuntarily put hypnosis in place. The assessor will be chosen from the two other teams present in the other two modules (each module is a seven-bed unit and has no physical communication with the other two) after the start of the procedure for setting up the NIV, with or without hypnosis, in order to be certain that he had no visual contact with the patient and the caregivers present before the evaluation. The implementation of the NAV will take place as usually carried out in the service. Receives: Other: NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Quantification of comfort by a Digital Verbal Comfort Scale 2 hours after initiation of NIV (from 0 to 10, 0 being the minimum comfort felt and 10 the maximum comfort felt by the patient)
Measured: 2 hours after initiation of NIV
Secondary outcomes (10)
Anxiety
Assessment of anxiety (Numerical Verbal Scale from 0 to 10) at inclusion, 30 minutes, 2 hours and 24 hours after the implementation of the NIV
Measured: Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV
First NIV session duration
Calculation of the number of hours of the first NIV session
Measured: At the end of the first NIV session
Comfort
Comfort assessment at inclusion, 30 minutes and 24 hours after the implementation of the NIV (Digital Verbal Scale from 0 to 10)
Measured: Before and 30 minuts and 24 hours after the implementation of the NIV
TcpCO2
Decrease in PaCO2: Installation of a transcutaneous sensor and measurement of TcpCO2 at inclusion, 30 minutes, 2 hours and 24 hours after the establishment of the NIV
Measured: Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV
NIV duration
Calculation of the number of hours of NIV in the first 24 hours of treatment
Measured: after the first 24 hours of treatment
dyspnea
Assessment of the dyspnea felt by the patient 2 hours after the setting up of the NIV: +2: significant improvement; +1 slight improvement; 0 No change; -1 slight deterioration; -2 significant deterioration.
Measured: 2 hours after the setting up of the NIV
Intubation
Number of intubations: calculation of the number of patients intubated during the ICU stay.
Measured: Day 28
Stay duration
Duration of stay in intensive care
Measured: Day 28
anxiolytic treatment prescription
Record of the number of patients who had to have a prescription for anxiolytics during hospitalization in intensive care.
Measured: Day 28
stress
Evaluation of the stress of the healthcare team by a numerical verbal scale from 0 to 10 (0 being no stress and 10 the greatest possible stress felt) at inclusion, 30 minutes and 2 hours after NIV initiation
Measured: Before and 30 minuts and 2 hours after the implementation of the NIV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start20 Nov 2021
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Model description
- Prospective monocentric, controlled, randomized, superiority, open study with a blind assessor, on two parallel groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220463
- Sponsor's protocol ID
- 35RC19_9747_HYVIR
- Other IDs
- 2019-A02238-49, 19/08/14/42258
- Acronym
- HYVIR
- Status last verified
- Jun 2025
- First submitted
- 20 Dec 2019
- Last updated
- 24 Jun 2025
- 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYVIR : Interest of Hypnosis During the Implementation of Non-invasive Ventilation in a Patient With COPD and/or Obesity With a BMI Greater Than 30, Conscious With Acute Respiratory Distress in the Adult Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04220463
- Acronym / sponsor ID
- HYVIR / 35RC19_9747_HYVIR
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Obesity With a BMI Greater Than 30, Acute Respiratory Distress in Adult Intensive Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 7 Jan 2020 (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.
Discomfort during respiratory decompensation of a patient with chronic obstructive pulmonary disease (COPD) and/or obesity with a BMI greater than 30, in intensive care and the establishment of non-invasive ventilation (NIV) is frequent and a source of failure. this therapy. Pharmacological treatments may be impossible due to the pathology, the risk of it worsening and adverse effects. In this context, hypnosis appears to be a tool that would promote comfort and thus increase tolerance of NIV.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective monocentric, controlled, randomized, superiority, open study with a blind assessor, on two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Hypnosis group | Experimental | Other: Hypnosis + NIVFor the hypnosis group, hypnotic support is set up by a doctor/IDE previously trained and dedicated during the implementation of the NIV. The dedicated doctor/IDE will be presented before the start of the NIV setup procedure and will start the hypnosis session a few minutes before the mask is put on. The procedure for setting up the NAV may begin after agreement from the dedicated doctor/IDE. |
| Control group | Placebo comparator | Other: NIVIn the control group, in order to preserve the knowledge of the evaluator, the doctor/IDE dedicated to hypnosis is present in the service but does not intervene in the care so as not to be tempted to involuntarily put hypnosis in place. The assessor will be chosen from the two other teams present in the other two modules (each module is a seven-bed unit and has no physical communication with the other two) after the start of the procedure for setting up the NIV, with or without hypnosis, in order to be certain that he had no visual contact with the patient and the caregivers present before the evaluation. The implementation of the NAV will take place as usually carried out in the service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Glasgow score = 15
- Need during use of non-invasive ventilation
Key exclusion criteria (7 listed)
- Procedure to be carried out in extreme urgency (PaCO2 too high and leading to an immediate vital risk, and / or PaO2 too low) on medical decision
- Confusional state making hypnosis impossible
- Decompensated psychiatric illness
- Patient entering with an NIV in place already installed in another department. The subject becomes included again at the end of the treatment with NIV if however he needs it again.
- Patient already included in the study during previous non-invasive ventilation
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 |
|---|---|---|
| Hypnosis + NIVFor the hypnosis group, hypnotic support is set up by a doctor/IDE previously trained and dedicated during the implementation of the NIV. The dedicated doctor/IDE will be presented before the start of the NIV setup procedure and will start the hypnosis session a few minutes before the mask is put on. The procedure for setting up the NAV may begin after agreement from the dedicated doctor/IDE. | Other | Hypnosis group |
| NIVIn the control group, in order to preserve the knowledge of the evaluator, the doctor/IDE dedicated to hypnosis is present in the service but does not intervene in the care so as not to be tempted to involuntarily put hypnosis in place. The assessor will be chosen from the two other teams present in the other two modules (each module is a seven-bed unit and has no physical communication with the other two) after the start of the procedure for setting up the NIV, with or without hypnosis, in order to be certain that he had no visual contact with the patient and the caregivers present before the evaluation. The implementation of the NAV will take place as usually carried out in the service. | Other | Control group |
Primary outcome
Comfort
Time frame: 2 hours after initiation of NIV
Quantification of comfort by a Digital Verbal Comfort Scale 2 hours after initiation of NIV (from 0 to 10, 0 being the minimum comfort felt and 10 the maximum comfort felt by the patient)
10 secondary outcomes
Anxiety
Time frame: Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV
First NIV session duration
Time frame: At the end of the first NIV session
Comfort
Time frame: Before and 30 minuts and 24 hours after the implementation of the NIV
TcpCO2
Time frame: Before and 30 minuts, 2 hours and 24 hours after the implementation of the NIV
NIV duration
Time frame: after the first 24 hours of treatment
dyspnea
Time frame: 2 hours after the setting up of the NIV
Intubation
Time frame: Day 28
Stay duration
Time frame: Day 28
anxiolytic treatment prescription
Time frame: Day 28
stress
Time frame: Before and 30 minuts and 2 hours after the implementation of the NIV
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 24 Jun 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis + NIV and NIV in people with Chronic Obstructive Pulmonary Disease (COPD) and Obesity With a BMI Greater Than 30, run by Rennes University Hospital 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort (time frame: 2 hours after initiation of NIV). 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 24 Jun 2025.