RT Journal Article
SR Electronic
T1 Hypnosis for the Management of COPD-related anxiety and dyspnea in Pulmonary Rehabilitation - rationale and design for a cluster-randomised, active-control trial [HYPNOBPCO_2]
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 00565-2021
DO 10.1183/23120541.00565-2021
A1 Hernán Anlló
A1 Bertrand Herer
A1 Agathe Delignières
A1 Adelina Ghergan
A1 Yolaine Bocahu
A1 Isabelle Segundo
A1 Cécile Moulin
A1 François Larue
YR 2022
UL http://openres.ersjournals.com/content/early/2022/01/04/23120541.00565-2021.abstract
AB 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.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.