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)

Autor: Hernán Anlló,, Bertrand Herer, Agathe Delignières, Adelina Ghergan, Yolaine Bocahu, Isabelle Segundo, Cécile Moulin, François Larue
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: ERJ Open Research, Vol 8, Iss 1 (2021)
Druh dokumentu: article
ISSN: 2312-0541
23120541
DOI: 10.1183/23120541.00565-2021
Popis: 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.
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