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

Condition(s) studied

Investigational drug(s) / intervention(s)

Hypnosis: Five medical hypnosis sessions, each scheduled 7 ± 2 days apart

standardized telephone calls: Four standardized telephone calls, made at 7 ± 2 day intervals

Study 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

Primary outcome measure(s)

• Change in quality of life assessed using the total score of the St George's Respiratory Questionnaire (SGRQ) — 6 weeks
  Change in the total score of the St. George's Respiratory Questionnaire (SGRQ), which assesses respiration-related quality of life, at 6 weeks after randomization and baseline. The SGRQ is a self-administered questionnaire that assesses three domains: symptoms, activity, and impact on daily life. It permits calculation of a total score from these three domains, reflecting respiration-related quality of life. Study participants will complete this questionnaire at the first visit, the randomization visit (V1), and the final visit (V6). The two visits will take place 6 weeks apart (with an extra week's buffer in case of unexpected delays regarding one of the visits or hypnosis sessions). (Total score ranges from 0 to 100, 0 = no impact of the disease on quality of life, 100 = maximum impact on quality of life.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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