Evaluation of the Benefits of Hypnosis in Improving the Quality of Life of Patients With Chronic … (NCT07637604) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the Benefits of Hypnosis in Improving the Quality of Life of Patients With Chronic Obstructive Pulmonary Disease (COPD) Suffering From Persistent Dyspnea
France154 participantsStarted 2026-09-01
Plain-language summary
Chronic Obstructive pulmonary Disease (COPD) is a common progressive disorder characterized by persistent airflow limitation. It is usually caused by exposure to tobacco smoke, toxic particles, or toxic gases. COPD is characterized by cough, sputum production, and dyspnea, which is the cardinal symptom and is included in the criteria for severity. Dyspnea is a major source of suffering and disability, especially when it persists at rest.
Despite proper medical treatment, many patients continue to suffer from persistent dyspnea that significantly impairs their daily functioning and quality of life. Complementary approaches such as yoga and relaxation techniques are therefore recommended by some experts. Hypnosis is one of these practices. It has been shown to be effective in the management of both acute and chronic pain and it can abolish several types of experimentally induced dyspnea in healthy volunteers. In adults with COPD, a single hypnosis session has been shown to reduce anxiety immediately, though only temporarily. However, according to a recent retrospective study, a median of three hypnosis sessions increases the distance covered in the 6-minute walk test in COPD patients.
The investigators therefore hypothesize that several hypnosis sessions will improve the quality of life of adult outpatients with COPD who suffer from persistent dyspnea. The study plans to recruit 154 patients with severe dyspnea (mMRC(modified Medical Research Council Dyspnea Scale) 3 or 4). They will be randomly assigned to either the experimental group or the control group. Patients in the experimental group will participate in 5 sessions of medical hypnosis spaced 7 ± 2 days apart. The first hypnosis session will take place at the end of the enrollment visit. The final session will be held via teleconsultation. Four standardized telephone calls, spaced 7 ± 2 days apart, will replace the hypnosis sessions in the control group. The primary outcome of the study will be the evolution of quality of life, assessed 6 weeks after the start of the study as compared to baseline. Secondary outcomes will focus on changes in exercise capacity, dyspnea, anxiety, depression, dyspnea-related catastrophizing, self-efficacy, and pleasure in life.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>18 years
* COPD (any etiology), referred by a pulmonologist and managed according to GOLD 2024 guidelines except for pulmonary rehabilitation that is not required
* Outpatient follow-up
* Residing in Paris or the inner suburbs for centers located within the city limits, or within a 30-minute drive for centers located outside the city limits of Paris.
* Dyspnea rated as mMRC 3 or 4
* Having signed an informed consent form
Exclusion Criteria:
* Vulnerable individuals (under legal guardianship or curatorship) or deprived of liberty
* Pregnant or breastfeeding women
* Absolute or relative contraindication to the 6 minutes walk test, spirometry or body plethysmography
* Current COPD exacerbation or exacerbation resolved less than one week ago
* Psychosis or other psychiatric disorder likely to interfere with study participation
* Profound hearing impairment
* Cognitive impairment
* Use of psychedelic substances (ex: LSD (Lysergic acid diethylamide), psilocybin, etc.)
* Current participation in interventions that may be related to hypnosis: any kind of meditation, relaxation, sophrology, heart coherence training, yoga, Qi Gong, holotropic breathing, EMDR (Eye Movement Desensitization and Reprocessing) or any psychotherapies involving eye movements, as well as shamanic practices and brief psychotherapies or cognitive-behavioral therapies
* Previous management of dyspnea using hypnosis
* Ongoing pulmonary rehabilitation (physiotherapy outside a structur…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses hypnosis to try to improve quality of life in COPD patients with persistent breathlessness — given my current level of dyspnea and my existing COPD management plan, is this the kind of approach that might make sense for me to explore?
2The trial isn't recruiting yet — do you know roughly when it might open, and is it worth waiting for, or should we focus on other options for managing my breathlessness in the meantime?
3Since this is a Phase NA study focused on a non-drug intervention like hypnosis, what is currently known about the safety and any risks of using hypnosis in people with COPD, and are there any reasons it might not be appropriate for me specifically?
4The trial measures quality of life using something called the St George's Respiratory Questionnaire — can you explain what that tool actually captures, and how meaningful a change in that score would be for my day-to-day life with breathlessness?
5Are there standard or already-proven treatments for COPD-related persistent dyspnea — like pulmonary rehabilitation or certain medications — that I should consider trying before or alongside looking into a trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in quality of life assessed using the total score of the St George's Respiratory Questionnaire (SGRQ)