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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Hypnosis
  • standardized telephone calls

Treatment groups

154 Participants
are divided into 2 treatment groups