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Not Yet Recruiting NCT07637604

Evaluation of the Benefits of Hypnosis in Improving the Quality of Life of Patients With Chronic Obstructive Pulmonary Disease (COPD) Suffering From Persistent Dyspnea

Conditions: Chronic Obstructive Pulmonary Disease (COPD), Dyspnea

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 154
Sponsor: Assistance Publique - Hôpitaux de Paris

Location: APHP, Hôpital Pitié-Salpêtrière Paris France

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.

Eligibility Criteria

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 structured rehabilitation program initiated before study inclusion is not an exclusion criterion) * Inability to be reached by phone or teleconsultation * Lack of health insurance (French social security) coverage * Participation in another clinical trial * End of life

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Source: ClinicalTrials.gov (NCT07637604). StuddyBuddy aggregates publicly available trial information.