No abstract

Complementary psychological care is recommended for COPD, as it significantly reduces anxiety, and boosts the pulmonary rehabilitation efficacy. In a precedent trial (HYPNOBPCO_1, ISRCTN10029862), administering a single hypnosis session was linked to reduced anxiety and improved breathing mechanics in intermediate and advanced COPD patients. However, whether hypnosis could improve self-management of anxiety and dyspnea in COPD during pulmonary rehabilitation is yet to be investigated.This is the protocol for HYPNOBPCO_2, a 2-arm, cluster-randomised, statistician-blinded superiority monocenter trial (NCT04868357). Its aim is to assess the efficacy of hypnosis as a tool to manage anxiety and dyspnea during a Pulmonary Rehabilitation Program (PRP). Clusters of COPD patients eligible to the conventional hospital-based PRP at the Centre Hospitalier de Bligny (CHB), will be randomised and evenly allocated into two parallel arms: “Hypnosis” (treatment) and “Relaxation” (active control). “Hypnosis” will consist of the CHB's conventional 4-week group PRP, supplemented by 2 educational sessions for teaching self-hypnosis. “Relaxation” will be identical, except standard relaxation exercises will be taught instead. Primary end-point will consist of assessing weekly changes in anxiety throughout the PRP, additional to total anxiety change after treatment completion. Anxiety will be determined by the 6-item version of the State-Trait Anxiety Inventory (STAI-6). Secondary outcomes will include change in the 6-minute walking test and the COPD assessment test (CAT). Further follow-up outcomes will include CAT and STAI-6 retests, re-hospitalization rate, action plan use, and persistence in self-hypnosis use, throughout the 12 weeks ensuing PRP completion.