Chronic Obstructive Pulmonary DiseaseNCT04010825
Impact of Hypnosis Intervention on the Emotional Dimension of Dyspnea in Patients With COPD.
A study testing Hypnosis intervention focused on the emotional dimension of the dyspnea in people with Chronic Obstructive Pulmonary Disease, run by 5 Santé at 2 sites in France.
Trial summary
The purpose of the clinical study is to compare the effect of hypnosis intervention on the emotional dimension of the dyspnea during a pulmonary rehabilitation program to the pulmonary rehabilitation program alone. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Hypnosis intervention focused on the emotional dimension of the dyspnea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Oct 2019to 29 Feb 2024
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted for a 4-week inpatient pulmonary rehabilitation program
- COPD diagnosis with a value of the first second of forced expiration (FEV1) < 80% of theoretical values
- 40 and 75 years old
- Reading and writing skills
Who cannot join
- Inability to answer a questionnaire
- Patient with psychosis or psychiatric disorders with delusions (or delusions history)
- Pregnant women
- Protected adults
- Participation in another study, with the exception of observational studies
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique du Souffle la Vallonie
Lodève, 34700
Clinique du Souffle la Solane
Osséja, 66340
About this study
Official title: Impact of Hypnosis Intervention Focused on the Emotional Dimension of Dyspnea on the Maintenance of Benefits for Patients With COPD After a Pulmonary Rehabilitation: A Multicenter Randomized Controlled Clinical Study
The purpose of the clinical study is to compare the effect of hypnosis intervention on the emotional dimension of the dyspnea during a pulmonary rehabilitation program to the pulmonary rehabilitation program alone. This study will determine if the hypnosis intervention will lead to better maintenance of benefits obtained than the original described method.
Read the detailed description
While physical activity level is the best predictor of life expectancy for patients with chronic obstructive pulmonary disease (COPD), the majority of patients have physical activity levels well below guidelines. One of the main barriers to regular activity is anxiety related to dyspnea. Defined as a subjective experience of discomfort during breathing, dyspnea is described as a multidimensional phenomenon integrating both the impact dimension (daily disability), the sensory dimension (intensity of dyspnea) and the emotional dimension (unpleasant and anxiety-aspects). The most effective treatment to reduce dyspnea is pulmonary rehabilitation. An overall improvement in dyspnea, and more specifically in its emotional dimension, has been achieved by reducing dyspnea anxiety. By reducing one of the major barriers to regular physical activity, the level of post-rehabilitation physical activity should also be improved. However, paradoxically, many studies have reported that there has been no change in the level of physical activity of patients in post-rehabilitation. A possible hypothesis to explain this decoupling between the improvement of the emotional dimension of dyspnea and the absence of behavioral modification, lies in the disappearance of the effects once at home. Indeed, during a pulmonary rehabilitation stay, patients practice under health professionals' supervision and advices with regular feedback on their abilities. When patients return home left on their own again, dyspnea anxiety is likely to reappear and motivation may not be enough.
Several techniques have been proposed to complement traditional interventions in order to strengthen rehabilitation effects. Unfortunately, these are not effective. The use of hypnosis as a complement to rehabilitation programs is a promising perspective to maintain the benefits on the emotional dimension of dyspnea after a rehabilitation program. Its benefits have already been demonstrated in the reduction of acute and chronic pains, in a long-term effectiveness using self-hypnosis techniques. These ensure the continuity of remote management of the intervention. Given the analogy between pain and dyspnea, hypnosis could therefore constitute a therapeutic solution as a complement to rehabilitation to durably reduce dyspnea anxiety in patients with COPD, and promote a better behavior at middle and long term.
The investigators hypothesize that hypnosis used in addition to a 4-week pulmonary rehabilitation program will maintain the benefits on the emotional dimension of dyspnea at 6 months in the experimental group compared to a control group.
The main objective is to evaluate the impact of a hypnosis intervention during a pulmonary rehabilitation program on the emotional dimension of dyspnea 6 months after patients return home (T2).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Hypnosis intervention focused on the emotional dimension of the dyspnea
- Keywords
- Dyspnea, Pulmonary rehabilitation, Physical activity, Hypnosis, Anxiety, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Motor Activity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis intervention focused on the emotional dimension of the dyspneaOther
Individual hypnosis sessions will be for 1 hour. Each hypnosis session will be standardized and evaluated using a script and an observation grid ( Visual Analogic Scale comfort, patient's hypnotic state...) written in collaboration with experts from Institut Milton Hyland Erickson Toulouse France (IMHETO).
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis Arm | Experimental | In parallel with an inpatient pulmonary rehabilitation program, nine visits will be carried out :
* V0 : an inclusion visit
* V1 : a randomization visit
* V2 to V6 : five visits with hypnosis sessions
* V7 : a end-stay visit
* V8 : a 6-month post-rehabilitation visit ( by phone call)
The five hypnosis sessions (V2 to V6) will be spread over three weeks of rehabilitation program (1 to 2 hypnosis sessions per week).
For V1, V7 and V8 : questionnaires will be filled about : quality of life (CAT questionnaire), the three dimensions of dyspnea (mMRC, LCADL and MDP questionnaires), anxiety and depression (HADS questionnaire), post-traumatic stress ( PCLS questionnaire), sedentarity and physical activity (SIMPAQ questionnaire). Other data will be also collected on : previous experiences with hypnosis, self-hypnosis and relaxation, number of exacerbations and hospitalizations in the past 6 months, drug treatment, psychotropic drug use and dosage and psychological follow-up. Receives: Other: Hypnosis intervention focused on the emotional dimension of the dyspnea |
| Control Arm | No intervention | In parallel with an inpatient pulmonary rehabilitation program, no additional intervention will be carry out and four visits will be carried out : * V0 : an inclusion visit * V1 : a randomization visit * V7 : a end-stay visit * V8 : a 6-month post-rehabilitation visit ( by phone call) For V1, V7 and V8 : questionnaires will be filled about : quality of life (CAT questionnaire), the three dimensions of dyspnea (mMRC, LCADL and MDP questionnaires), anxiety and depression (HADS questionnaire), post-traumatic stress ( PCLS questionnaire), sedentarity and physical activity (SIMPAQ questionnaire). Other data will be also collected on : previous experiences with hypnosis, self-hypnosis and relaxation, number of exacerbations and hospitalizations in the past 6 months, drug treatment, psychotropic drug use and dosage and psychological follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential of the emotional dimension of dyspnea 6 months after pulmonary rehabilitation (PR)
Assessing differential of the emotional dimension of dyspnea score on the Multidimensional Dyspnea Profile scale (MDP questionnaire Meek et al 2012) 6 months after pulmonary rehabilitation (PR).
MDP is a 11 items questionnaire. Each item is graded 0-10. 5 items are devoted to the emotional dimension of dyspnea. High scores indicate high prevalence of symptoms.
As proposed by Morélot-Panzini et al in 2016, for filling it up, patient will be asked to focus on his worst dyspnea experience that happened oin the last two weeks.
Measured: Change from baseline (T0) to 6 month follow-up (T2)
Secondary outcomes (15)
Differential of the emotional dimension of dyspnea from baseline to PR end-stay and from PR end-stay to 6 months after PR
Assessing differential of the emotional dimension of dyspnea score on the Multidimensional Dyspnea Profile scale (MDP questionnaire Meek et al 2012) from baseline to PR end-stay and from PR end-stay to 6 months after PR .
MDP is a 11 items questionnaire. Each item is graded 0-10. 5 items are devoted to the emotional dimension of dyspnea. High scores indicate high prevalence of symptoms.
As proposed by Morélot-Panzini et al in 2016, for filling it up, patient will be asked to focus on his worst dyspnea experience that happened oin the last two weeks.
Measured: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) and from T1 to 6 month follow-up (T2)
Differential of the impact dimension of dyspnea
Assessing differential of the impact dimension of dyspnea score on the modified Medical Research Council scale ( mMRC questionnaire) and on the London Chest of Activity Daily Living (LCADL) at the PR end-stay and 6 months after PR.
mMRC is a 1 item questionnaire graded 0-4. High score indicates high prevalence of symptoms.
LCADL is a15-item, self-administered questionnaire which allows an evaluation of dyspnea in patients with COPD during daily activities divided into four components: self-care, domestic, physical, and leisure. Patients could score from 0: "I would not do anyway" to 5: "I need someone else to do this". LCADL score is calculated by aggregating the points assigned to each question, with a higher score representing maximal disability.
Measured: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Differential of the sensory dimension of dyspnea
Assessing differential of the sensory dimension of dyspnea score on the Multidimensional Dyspnea Profile scale (MDP questionnaire Meek et al 2012) at the PR end-stay and 6 months after PR.
MDP is a 11 items questionnaire. Each item is graded 0-10. 6 items are devoted to the sensory dimension of dyspnea. High scores indicate high prevalence of symptoms.
As proposed by Morélot-Panzini et al in 2016, for filling it up, patient will be asked to focus on his worst dyspnea experience that happened oin the last two weeks.
Measured: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Differential of the post-traumatic stress disorder
Assessing differential of the post-traumatic stress disorder score (PCLS questionnaire) at the PR end-stay and 6 months after PR.
PCLS is a 17 items questionnaire. Each item is graded 1-5. A score higher than 44 indicates patient has a post-traumatic disorder as defined by in Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) (Weathers et al, 1993).
Measured: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Differential of the quality of life
Assessing differential of the quality of life score (COPD Assessment Test-CAT questionnaire) at the PR end-stay and 6 months after PR.
CAT is a COPD specific questionnaire including 8 items. Each item is graded 0-5. Global score is comprised between 0 and 40. Higher global score is higher COPD impact on patient's quality of life is.
Measured: Changes from baseline (T0) to at the end of the 4-weeks PR , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Differential of the anxiety and depression
Assessing differential of the anxiety and depression score (Hospital Anxiety and Depression Scale -HADS questionnaire) at the PR end-stay and 6 months after PR.
HADS is a 14 items questionnaire (7 items for anxiety and 7 items for depression). Each item is graded 0-3. A score higher than 7 indicates anxiety and/or depression
Measured: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Differential of the physical activity and sedentarity levels
Assessing differential of the physical activity and sedentarity levels (Simple Physical Activity Questionnaire (SIMPAQ) at the PR end-stay and 6 months after PR.
SIMPAQ is a 5 items questionnaire assessing in the last two weeks physical activity levels, sedentary times and time in bed.
Measured: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Questionnaire for assessing psychotropic drug quantity and dosage
A short questionnaire will be used for assessing differential of psychotropic drug quantity and dosage at the PR end-stay and 6 months after PR.
Measured: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Number of exacerbations and hospitalizations
Assessing differential of number of exacerbations and hospitalizations 6 months after PR.
Number of exacerbations and hospitalizations happened during the 6 last months will be indicated at T0 (baseline) and at T2 (6 month follow-up)
Measured: Changes from baseline (T0) to 6 month follow-up (T2)
Hypnosis frequency
Assessing hypnosis frequency 6 months after PR.
Measured: Changes from baseline (T0) to 6 month follow-up (T2)
Number of participants with previous hypnosis experiences
A questionnaire will be used for assessing patient's previous hypnosis experiences (previous to PR). (counting)
Measured: Months or/and years before PR baseline (T0)
Self-Hypnosis frequency
Assessing self-hypnosis frequency 6 months after PR.
Measured: Changes from baseline (T0) to 6 month follow-up (T2)
Number of participants with previous self-hypnosis experiences
A questionnaire will be used for assessing patient's previous self-hypnosis experiences (previous to PR). (counting)
Measured: Months or/and years before PR baseline (T0)
Relaxation methods frequency
Assessing relaxation methods frequency 6 months after PR.
Measured: Changes from baseline (T0) to 6 month follow-up (T2)
Number of participants with previous relaxation methods experiences
A questionnaire will be used for assessing patient's previous relaxation methods experiences (previous to PR). (counting)
Measured: Months or/and years before PR baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start25 Oct 2019
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- 5 Santé
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriana Castanyer, Principal investigator, 5 SANTE - Clinique du Souffle la SolaneNelly Heraud, PhD, Study director, 5 Santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010825
- Sponsor's protocol ID
- DYSPNEMO
- Status last verified
- Mar 2024
- First submitted
- 26 Jun 2019
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandes N, Alexandre F, Molinier V, Castanyer A, Moine E, Heraud N. Effect of dyspnoea-oriented hypnosis as an adjunct to pulmonary rehabilitation on the affective dimension of dyspnoea and physical activity level: a randomised controlled trial. ERJ Open Res. 2026 Feb 2;12(1):00621-2025. doi: 10.1183/23120541.00621-2025. eCollection 2026 Jan.
PubMed 41635580
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hypnosis Intervention Focused on the Emotional Dimension of Dyspnea on the Maintenance of Benefits for Patients With COPD After a Pulmonary Rehabilitation: A Multicenter Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04010825
- Acronym / sponsor ID
- DYSPNEMO
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Dyspnea, Pulmonary rehabilitation, Physical activity, Hypnosis, Anxiety, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- 5 SantéUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 8 Jul 2019 (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.
The purpose of the clinical study is to compare the effect of hypnosis intervention on the emotional dimension of the dyspnea during a pulmonary rehabilitation program to the pulmonary rehabilitation program alone. This study will determine if the hypnosis intervention will lead to better maintenance of benefits obtained than the original described method.
Detailed description
While physical activity level is the best predictor of life expectancy for patients with chronic obstructive pulmonary disease (COPD), the majority of patients have physical activity levels well below guidelines. One of the main barriers to regular activity is anxiety related to dyspnea. Defined as a subjective experience of discomfort during breathing, dyspnea is described as a multidimensional phenomenon integrating both the impact dimension (daily disability), the sensory dimension (intensity of dyspnea) and the emotional dimension (unpleasant and anxiety-aspects). The most effective treatment to reduce dyspnea is pulmonary rehabilitation. An overall improvement in dyspnea, and more specifically in its emotional dimension, has been achieved by reducing dyspnea anxiety. By reducing one of the major barriers to regular physical activity, the level of post-rehabilitation physical activity should also be improved. However, paradoxically, many studies have reported that there has been no change in the level of physical activity of patients in post-rehabilitation. A possible hypothesis to explain this decoupling between the improvement of the emotional dimension of dyspnea and the absence of behavioral modification, lies in the disappearance of the effects once at home. Indeed, during a pulmonary rehabilitation stay, patients practice under health professionals' supervision and advices with regular feedback on their abilities. When patients return home left on their own again, dyspnea anxiety is likely to reappear and motivation may not be enough.
Several techniques have been proposed to complement traditional interventions in order to strengthen rehabilitation effects. Unfortunately, these are not effective. The use of hypnosis as a complement to rehabilitation programs is a promising perspective to maintain the benefits on the emotional dimension of dyspnea after a rehabilitation program. Its benefits have already been demonstrated in the reduction of acute and chronic pains, in a long-term effectiveness using self-hypnosis techniques. These ensure the continuity of remote management of the intervention. Given the analogy between pain and dyspnea, hypnosis could therefore constitute a therapeutic solution as a complement to rehabilitation to durably reduce dyspnea anxiety in patients with COPD, and promote a better behavior at middle and long term.
The investigators hypothesize that hypnosis used in addition to a 4-week pulmonary rehabilitation program will maintain the benefits on the emotional dimension of dyspnea at 6 months in the experimental group compared to a control group.
The main objective is to evaluate the impact of a hypnosis intervention during a pulmonary rehabilitation program on the emotional dimension of dyspnea 6 months after patients return home (T2).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis Arm | Experimental | Other: Hypnosis intervention focused on the emotional dimension of the dyspneaIn parallel with an inpatient pulmonary rehabilitation program, nine visits will be carried out : * V0 : an inclusion visit * V1 : a randomization visit * V2 to V6 : five visits with hypnosis sessions * V7 : a end-stay visit * V8 : a 6-month post-rehabilitation visit ( by phone call) The five hypnosis sessions (V2 to V6) will be spread over three weeks of rehabilitation program (1 to 2 hypnosis sessions per week). For V1, V7 and V8 : questionnaires will be filled about : quality of life (CAT questionnaire), the three dimensions of dyspnea (mMRC, LCADL and MDP questionnaires), anxiety and depression (HADS questionnaire), post-traumatic stress ( PCLS questionnaire), sedentarity and physical activity (SIMPAQ questionnaire). Other data will be also collected on : previous experiences with hypnosis, self-hypnosis and relaxation, number of exacerbations and hospitalizations in the past 6 months, drug treatment, psychotropic drug use and dosage and psychological follow-up. |
| Control Arm | No intervention | –In parallel with an inpatient pulmonary rehabilitation program, no additional intervention will be carry out and four visits will be carried out : * V0 : an inclusion visit * V1 : a randomization visit * V7 : a end-stay visit * V8 : a 6-month post-rehabilitation visit ( by phone call) For V1, V7 and V8 : questionnaires will be filled about : quality of life (CAT questionnaire), the three dimensions of dyspnea (mMRC, LCADL and MDP questionnaires), anxiety and depression (HADS questionnaire), post-traumatic stress ( PCLS questionnaire), sedentarity and physical activity (SIMPAQ questionnaire). Other data will be also collected on : previous experiences with hypnosis, self-hypnosis and relaxation, number of exacerbations and hospitalizations in the past 6 months, drug treatment, psychotropic drug use and dosage and psychological follow-up. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted for a 4-week inpatient pulmonary rehabilitation program
- COPD diagnosis with a value of the first second of forced expiration (FEV1) < 80% of theoretical values
- 40 and 75 years old
- Reading and writing skills
Key exclusion criteria (5 listed)
- Inability to answer a questionnaire
- Patient with psychosis or psychiatric disorders with delusions (or delusions history)
- Pregnant women
- Protected adults
- Participation in another study, with the exception of observational studies
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 intervention focused on the emotional dimension of the dyspneaIndividual hypnosis sessions will be for 1 hour. Each hypnosis session will be standardized and evaluated using a script and an observation grid ( Visual Analogic Scale comfort, patient's hypnotic state...) written in collaboration with experts from Institut Milton Hyland Erickson Toulouse France (IMHETO). | Other | Hypnosis Arm |
Primary outcome
Differential of the emotional dimension of dyspnea 6 months after pulmonary rehabilitation (PR)
Time frame: Change from baseline (T0) to 6 month follow-up (T2)
Assessing differential of the emotional dimension of dyspnea score on the Multidimensional Dyspnea Profile scale (MDP questionnaire Meek et al 2012) 6 months after pulmonary rehabilitation (PR). MDP is a 11 items questionnaire. Each item is graded 0-10. 5 items are devoted to the emotional dimension of dyspnea. High scores indicate high prevalence of symptoms. As proposed by Morélot-Panzini et al in 2016, for filling it up, patient will be asked to focus on his worst dyspnea experience that happened oin the last two weeks.
15 secondary outcomes
Differential of the emotional dimension of dyspnea from baseline to PR end-stay and from PR end-stay to 6 months after PR
Time frame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) and from T1 to 6 month follow-up (T2)
Differential of the impact dimension of dyspnea
Time frame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Differential of the sensory dimension of dyspnea
Time frame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Differential of the post-traumatic stress disorder
Time frame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Differential of the quality of life
Time frame: Changes from baseline (T0) to at the end of the 4-weeks PR , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Differential of the anxiety and depression
Time frame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Differential of the physical activity and sedentarity levels
Time frame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Questionnaire for assessing psychotropic drug quantity and dosage
Time frame: Changes from baseline (T0) to at the end of the 4-weeks PR (T1) , from T0 to 6 month follow-up (T2) and from T1 to 6 month follow-up (T2)
Number of exacerbations and hospitalizations
Time frame: Changes from baseline (T0) to 6 month follow-up (T2)
Hypnosis frequency
Time frame: Changes from baseline (T0) to 6 month follow-up (T2)
Number of participants with previous hypnosis experiences
Time frame: Months or/and years before PR baseline (T0)
Self-Hypnosis frequency
Time frame: Changes from baseline (T0) to 6 month follow-up (T2)
Number of participants with previous self-hypnosis experiences
Time frame: Months or/and years before PR baseline (T0)
Relaxation methods frequency
Time frame: Changes from baseline (T0) to 6 month follow-up (T2)
Number of participants with previous relaxation methods experiences
Time frame: Months or/and years before PR baseline (T0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Derived from this study: PubMed 41635580Fernandes N, Alexandre F, Molinier V, Castanyer A, Moine E, Heraud N. Effect of dyspnoea-oriented hypnosis as an adjunct to pulmonary rehabilitation on the affective dimension of dyspnoea and physical activity level: a randomised controlled trial. ERJ Open Res. 2026 Feb 2;12(1):00621-2025. doi: 10.1183/23120541.00621-2025. eCollection 2026 Jan.
- 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. This study is not recruiting at the moment.
Adriana Castanyer principal investigator
5 SANTE - Clinique du Souffle la Solane
Nelly Heraud, PhD study director
5 Santé
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis intervention focused on the emotional dimension of the dyspnea in people with Chronic Obstructive Pulmonary Disease, run by 5 Santé at 2 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 5 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: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differential of the emotional dimension of dyspnea 6 months after pulmonary rehabilitation (PR) (time frame: Change from baseline (T0) to 6 month follow-up (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04010825, which also lists 1 linked publication.
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 5 Mar 2024.