Hypnosis for the management of COPD-related anxiety and dyspnoea in pulmonary rehabilitation: rationale and design for a cluster-randomised, active-control trial (HYPNOBPCO_2).

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 dyspnoea 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 monocentre trial (NCT04868357). Its aim is to assess the efficacy of hypnosis as a tool to manage anxiety and dyspnoea during a pulmonary rehabilitation programme (PRP). Clusters of COPD patients eligible for 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 two 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 six-item version of the State-Trait Anxiety Inventory (STAI-6). Secondary outcomes will include change in the 6-min walk test and the COPD assessment test (CAT). Further follow-up outcomes will include CAT and STAI-6 retests, re-hospitalisation rate, action plan use and persistence in self-hypnosis use, throughout the 12 weeks ensuing PRP completion.

Hypnosis for the Management of Anxiety and Dyspnea in COPD: A Randomized, Sham-Controlled Crossover Trial.

Background: Patients with chronic obstructive pulmonary disease (COPD) are prone to dyspnea, increased respiratory rate and other anxiety-inducing symptoms. Hypnosis constitutes a complementary procedure capable of improving subjective feelings of anxiety. Objective: Assessing the efficacy of a 15-minute hypnosis intervention for immediate improvement of anxiety in severe COPD patients. Methods: Twenty-one participants, COPD patients (mean FEV1 < 32.3%), were randomly assigned to two individual sessions in crossover (sham and hypnosis, 24-h washout period, arms: hypnosis-sham [n=11]/sham-hypnosis [n=10]). We tracked pre- and post-intervention anxiety (STAI-6 score) as primary endpoint. Results: Nineteen (90.5%) participants completed the study. Anxiety diminished significantly after hypnosis (STAI-6 scores -23.8% [SD = 18.4%] hypnosis vs -3.1% [32.8%] sham; χ2=8, P<0.01, Bayes Factor 5.5). Respiratory rate also decreased after hypnosis. Improvements in SpO2 and Borg exertion scores were registered after both conditions. Conclusion: A 15-minute hypnosis session improved participants' anxiety and lowered respiratory rate (as opposed to sham). Improvements in anxiety were correlated with an alleviation in respiratory strain. Results imply that hypnosis can contribute to the improvement of anxiety levels and breathing mechanics in severe COPD patients. Registration Id: ISRCTN10029862.