{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,2]],"date-time":"2025-08-02T16:59:03Z","timestamp":1754153943440,"version":"3.41.2"},"reference-count":44,"publisher":"Public Library of Science (PLoS)","issue":"7","license":[{"start":{"date-parts":[[2025,7,23]],"date-time":"2025-07-23T00:00:00Z","timestamp":1753228800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec037\">\n<jats:title>Introduction<\/jats:title>\n<jats:p>Noninvasive ventilation (NIV) is a cornerstone in the management of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD). The aim of this study is to assess the impact of music-based intervention on the efficiency of NIV in patients with AECOPD.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec038\">\n<jats:title>Methods<\/jats:title>\n<jats:p>It\u2019s a prospective, randomized, single-blinded, parallel-group trial. Critically ill COPD patients admitted for acute exacerbation and eligible for NIV will be included. Patients in the control group will receive only NIV. In the intervention group, patients will receive NIV with music-based intervention. The music will be delivered through headphones. Both groups will receive standard care in accordance with current clinical guidelines. The primary endpoint is the change in arterial Pressure of Carbon dioxide PaCO2, defined as the difference between baseline PaCO\u2082 (prior to NIV initiation) and PaCO\u2082 measured after 4 hours. Secondary endpoints will be recorded at different time points: change of PaCO2 over time (h<jats:sub>0<\/jats:sub>, h<jats:sub>2<\/jats:sub>, h<jats:sub>4<\/jats:sub>), unplanned interventions, changes in respiratory and cardiovascular parameters (h<jats:sub>0<\/jats:sub>, h<jats:sub>2<\/jats:sub>, h<jats:sub>4<\/jats:sub>), changes in Respiratory comfort (h<jats:sub>0<\/jats:sub>, h<jats:sub>2<\/jats:sub>, h<jats:sub>4<\/jats:sub>), Borg Dyspnea Scale (h<jats:sub>0<\/jats:sub>, h<jats:sub>2<\/jats:sub>, h<jats:sub>4<\/jats:sub>), Verbal Numeric Rating Scale for pain assessment (h<jats:sub>0<\/jats:sub>, h<jats:sub>2<\/jats:sub>, h<jats:sub>4<\/jats:sub>), Encephalopathy score (h<jats:sub>0<\/jats:sub>, h<jats:sub>2<\/jats:sub>, h<jats:sub>4<\/jats:sub>), Richmond Agitation-Sedation Scale (h<jats:sub>0<\/jats:sub>, h<jats:sub>2<\/jats:sub>, h<jats:sub>4<\/jats:sub>), and psychological assessment (Rapid Clinical Test For delirium, State Trait Anxiety Inventory, perceived stress scale) (h<jats:sub>0<\/jats:sub>, h<jats:sub>4<\/jats:sub>).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec039\">\n<jats:title>Discussion<\/jats:title>\n<jats:p>This study is expected to contribute reliable scientific evidence for the optimal management of AECOPD, potentially reducing the need for intubation and mechanical ventilation and their associated complications.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec040\">\n<jats:title>Trial registration<\/jats:title>\n<jats:p>The study was prospectively registered on the Pan African Clinical Trial Registry within the number PACTR202501862862010.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0328558","type":"journal-article","created":{"date-parts":[[2025,7,23]],"date-time":"2025-07-23T17:29:57Z","timestamp":1753291797000},"page":"e0328558","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficiency of a music-based intervention as an adjunct to the first noninvasive ventilation session in acute exacerbation of COPD: A randomized single-blind controlled trial protocol"],"prefix":"10.1371","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8698-9339","authenticated-orcid":true,"given":"Imen","family":"Ben Saida","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dhekra","family":"Chebil","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wassim","family":"Jomaa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marwa","family":"Zghidi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Khalil","family":"Attia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7557-2156","authenticated-orcid":true,"given":"Mohamed","family":"Boussarsar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2025,7,23]]},"reference":[{"author":"Chronic obstructive pulmonary disease (COPD)","key":"pone.0328558.ref001"},{"key":"pone.0328558.ref002","doi-asserted-by":"crossref","first-page":"1404615","DOI":"10.3389\/fimmu.2024.1404615","article-title":"Inflammation mechanism and research progress of COPD","volume":"15","author":"J Xu","year":"2024","journal-title":"Front Immunol"},{"issue":"8","key":"pone.0328558.ref003","article-title":"Role of Non-invasive ventilation (NIV) in managing acute exacerbations of chronic obstructive pulmonary disease (COPD): a systematic review","volume":"16","author":"SA Abualhamael","year":"2024","journal-title":"Cureus"},{"issue":"2","key":"pone.0328558.ref004","doi-asserted-by":"crossref","first-page":"1602426","DOI":"10.1183\/13993003.02426-2016","article-title":"Official ERS\/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure","volume":"50","author":"B Rochwerg","year":"2017","journal-title":"Eur Respir J"},{"issue":"4","key":"pone.0328558.ref005","first-page":"471","article-title":"Non-invasive ventilation in exacerbations of COPD","volume":"2","author":"N Ambrosino","year":"2007","journal-title":"Int J Chron Obstruct Pulmon Dis"},{"issue":"5","key":"pone.0328558.ref006","doi-asserted-by":"crossref","first-page":"443","DOI":"10.15537\/smj.2018.5.22058","article-title":"Evidence based synthesis for prevention of noninvasive ventilation related facial pressure ulcers","volume":"39","author":"JS Alqahtani","year":"2018","journal-title":"Saudi Med J"},{"issue":"5","key":"pone.0328558.ref007","doi-asserted-by":"crossref","first-page":"2400396","DOI":"10.1183\/13993003.00396-2024","article-title":"Clinical review of non-invasive ventilation","volume":"64","author":"GJ Criner","year":"2024","journal-title":"Eur Respir J"},{"issue":"8","key":"pone.0328558.ref008","doi-asserted-by":"crossref","first-page":"938","DOI":"10.5005\/jp-journals-10071-23950","article-title":"Role of sedation and analgesia during noninvasive ventilation: systematic review of recent evidence and recommendations","volume":"26","author":"HM Karim","year":"2022","journal-title":"Indian J Crit Care Med"},{"key":"pone.0328558.ref009","article-title":"ISCCM guidelines for the use of non-invasive ventilation in acute respiratory failure in adult ICUs","volume":"24","author":"R Chawla","year":"2020","journal-title":"Indian J Crit Care Med"},{"issue":"12","key":"pone.0328558.ref010","doi-asserted-by":"crossref","first-page":"1687","DOI":"10.3390\/healthcare11121687","article-title":"The effect of music as a non-pharmacological intervention on the physiological, psychological, and social response of patients in an intensive care unit","volume":"11","author":"M Lorek","year":"2023","journal-title":"Healthcare (Basel)"},{"issue":"21","key":"pone.0328558.ref011","doi-asserted-by":"crossref","first-page":"11500","DOI":"10.3390\/ijerph182111500","article-title":"Effectiveness of music-based intervention in improving uncomfortable symptoms in ICU patients: an umbrella review","volume":"18","author":"Y-F Chen","year":"2021","journal-title":"Int J Environ Res Public Health"},{"issue":"1","key":"pone.0328558.ref012","doi-asserted-by":"crossref","first-page":"379","DOI":"10.1186\/s13063-024-08220-8","article-title":"Generalized music therapy to reduce neuroactive drug needs in critically ill patients. Study protocol for a randomized trial","volume":"25","author":"G Mistraletti","year":"2024","journal-title":"Trials"},{"key":"pone.0328558.ref013","doi-asserted-by":"crossref","first-page":"978","DOI":"10.1111\/j.1365-2702.2009.02845.x","article-title":"Effects of music intervention on physiological stress response and anxiety level of mechanically ventilated patients in China: a randomised controlled trial","volume":"19","author":"L Han","year":"2010","journal-title":"J Clin Nurs"},{"issue":"22","key":"pone.0328558.ref014","doi-asserted-by":"crossref","first-page":"2335","DOI":"10.1001\/jama.2013.5670","article-title":"Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial","volume":"309","author":"LL Chlan","year":"2013","journal-title":"JAMA"},{"issue":"1","key":"pone.0328558.ref015","doi-asserted-by":"crossref","DOI":"10.1186\/s12906-025-04861-7","article-title":"The effect of music on patient anxiety undergoing bronchoscopy: a randomized controlled trial","volume":"25","author":"K Amani","year":"2025","journal-title":"BMC Complement Med Ther"},{"key":"pone.0328558.ref016","doi-asserted-by":"crossref","DOI":"10.1183\/13993003.01873-2018","article-title":"A musical intervention for respiratory comfort during noninvasive ventilation in the ICU","volume":"53","author":"J Messika","year":"2019","journal-title":"Eur Respir J"},{"issue":"12","key":"pone.0328558.ref017","article-title":"Music interventions for mechanically ventilated patients","volume":"2014","author":"J Bradt","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"key":"pone.0328558.ref018","first-page":"1","article-title":"Music-assisted relaxation during transition to non-invasive ventilation in people with motor neuron disease: a qualitative case series","author":"R Davies","year":"2016","journal-title":"Br J Music Ther"},{"issue":"8","key":"pone.0328558.ref019","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0135589","article-title":"Sympathetic tone induced by high acoustic tempo requires fast respiration","volume":"10","author":"K Watanabe","year":"2015","journal-title":"PLoS One"},{"issue":"4","key":"pone.0328558.ref020","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1177\/1479972309346754","article-title":"Comparison of the effectiveness of music and progressive muscle relaxation for anxiety in COPD--a randomized controlled pilot study","volume":"6","author":"VP Singh","year":"2009","journal-title":"Chron Respir Dis"},{"issue":"1","key":"pone.0328558.ref021","doi-asserted-by":"crossref","first-page":"128","DOI":"10.1097\/00044067-200002000-00014","article-title":"Music therapy as a nursing intervention for patients supported by mechanical ventilation","volume":"11","author":"LL Chlan","year":"2000","journal-title":"AACN Clin Issues"},{"issue":"3","key":"pone.0328558.ref022","doi-asserted-by":"crossref","first-page":"501","DOI":"10.4187\/respcare.07489","article-title":"Music therapy in adults with COPD","volume":"66","author":"J Huang","year":"2021","journal-title":"Respir Care"},{"issue":"2","key":"pone.0328558.ref023","doi-asserted-by":"crossref","first-page":"113","DOI":"10.3109\/08037059209077502","article-title":"Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. prospective randomized open blinded end-point","volume":"1","author":"L Hansson","year":"1992","journal-title":"Blood Press"},{"issue":"1","key":"pone.0328558.ref024","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1007\/s11739-018-1974-z","article-title":"Non-invasive ventilation in COPD exacerbation: how and why","volume":"14","author":"A Duca","year":"2019","journal-title":"Intern Emerg Med"},{"issue":"9219","key":"pone.0328558.ref025","doi-asserted-by":"crossref","first-page":"1931","DOI":"10.1016\/S0140-6736(00)02323-0","article-title":"Early use of non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease on general respiratory wards: a multicentre randomised controlled trial","volume":"355","author":"PK Plant","year":"2000","journal-title":"Lancet Lond Engl"},{"key":"pone.0328558.ref026","doi-asserted-by":"crossref","first-page":"100053","DOI":"10.1016\/j.xjmad.2024.100053","article-title":"Music interventions for posttraumatic stress disorder: a systematic review","volume":"6","author":"CC Wang","year":"2024","journal-title":"J Mood Anxiety Disord"},{"journal-title":"Zenodo","article-title":"Playlist for Music-Based Intervention in COPD Patients","year":"2025","key":"pone.0328558.ref027"},{"key":"pone.0328558.ref028","doi-asserted-by":"crossref","unstructured":"Gu\u00e9tin S, Falvay D, Chanques G, Jaber S, de Lattre S, Souche B. Evaluation of the Standardized MUSIC CARE\u00a9 App in the Treatment of Pain: The U-Shape Composing Technique. 2014;6.","DOI":"10.47513\/mmd.v6i2.179"},{"key":"pone.0328558.ref029","first-page":"213","article-title":"\u00c9valuation et standardisation d\u2019une nouvelle technique de musicoth\u00e9rapie dans la prise en charge de la douleur: le montage en \u00abU","volume":"11","author":"S Gu\u00e9tin","year":"2010","journal-title":"Douleurs Eval - Diagn - Trait"},{"key":"pone.0328558.ref030","article-title":"Musique et douleur\u00a0: la s\u00e9quence en \u00abU\u00bb, une solution th\u00e9rapeutique standardis\u00e9e et valid\u00e9e","author":"S Gu\u00e9tin","year":"2017","journal-title":"Douleur Analg"},{"key":"pone.0328558.ref031","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1016\/j.cbpa.2014.07.022","article-title":"A critical evaluation of automated blood gas measurements in comparative respiratory physiology","volume":"178","author":"CL Malte","year":"2014","journal-title":"Comp Biochem Physiol A Mol Integr Physiol"},{"issue":"1","key":"pone.0328558.ref032","article-title":"COPD-Lower Respiratory Tract Infection Visual Analogue Score (c-LRTI-VAS) validation in stable and exacerbated patients with COPD","volume":"8","author":"HJ Prins","year":"2021","journal-title":"BMJ Open Respir Res"},{"issue":"6","key":"pone.0328558.ref033","doi-asserted-by":"crossref","first-page":"1818","DOI":"10.1378\/chest.104.6.1818","article-title":"Prevalence and severity of neurologic dysfunction in critically ill patients. Influence on need for continued mechanical ventilation","volume":"104","author":"BJ Kelly","year":"1993","journal-title":"Chest"},{"issue":"8","key":"pone.0328558.ref034","doi-asserted-by":"crossref","first-page":"1189","DOI":"10.2169\/internalmedicine.1346-18","article-title":"Altered consciousness, non-invasive ventilation and hypoxemic respiratory failure: the trident question unresolved","volume":"58","author":"A M Esquinas","year":"2019","journal-title":"Intern Med"},{"issue":"10","key":"pone.0328558.ref035","doi-asserted-by":"crossref","first-page":"1338","DOI":"10.1164\/rccm.2107138","article-title":"The Richmond Agitation\u2013Sedation Scale: validity and reliability in adult intensive care unit patients","volume":"166","author":"CN Sessler","year":"2002","journal-title":"Am J Respir Crit Care Med"},{"issue":"3","key":"pone.0328558.ref036","doi-asserted-by":"crossref","first-page":"216","DOI":"10.1016\/S0099-1767(00)90093-X","article-title":"Usefulness of the modified 0-10 Borg scale in assessing the degree of dyspnea in patients with COPD and asthma","volume":"26","author":"KR Kendrick","year":"2000","journal-title":"J Emerg Nurs"},{"issue":"4","key":"pone.0328558.ref037","doi-asserted-by":"crossref","first-page":"390","DOI":"10.1197\/aemj.10.4.390","article-title":"Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department","volume":"10","author":"PE Bijur","year":"2003","journal-title":"Acad Emerg Med"},{"issue":"4","key":"pone.0328558.ref038","doi-asserted-by":"crossref","first-page":"496","DOI":"10.1093\/ageing\/afu021","article-title":"Validation of the 4AT, a new instrument for rapid delirium screening: a study in 234 hospitalised older people","volume":"43","author":"G Bellelli","year":"2014","journal-title":"Age Ageing"},{"issue":"6","key":"pone.0328558.ref039","doi-asserted-by":"crossref","first-page":"668","DOI":"10.15537\/smj.2016.6.13935","article-title":"Validity and reliability of an Arabic version of the state-trait anxiety inventory in a Saudi dental setting","volume":"37","author":"MA Bahammam","year":"2016","journal-title":"Saudi Med J"},{"issue":"1","key":"pone.0328558.ref040","doi-asserted-by":"crossref","first-page":"84","DOI":"10.1016\/j.ijnurstu.2011.07.012","article-title":"An Arabic version of the Perceived Stress Scale: Translation and validation study","volume":"49","author":"T Almadi","year":"2012","journal-title":"Int J Nurs Stud"},{"issue":"9","key":"pone.0328558.ref041","doi-asserted-by":"crossref","first-page":"4920","DOI":"10.62347\/VGQC2142","article-title":"Efficacy of noninvasive ventilator treatment in patients with severe chronic obstructive pulmonary disease (COPD) type II respiratory failure","volume":"16","author":"M Yibulayin","year":"2024","journal-title":"Am J Transl Res"},{"issue":"1","key":"pone.0328558.ref042","first-page":"1","article-title":"Methodological sheet n\u00b01: How to calculate the size of a sample for an observational study?","volume":"98","author":"Z Serhier","year":"2020","journal-title":"Tunis Med"},{"issue":"1","key":"pone.0328558.ref043","doi-asserted-by":"crossref","first-page":"47","DOI":"10.4046\/trd.2021.0062","article-title":"The long-term efficacy of domiciliary noninvasive positive-pressure ventilation in chronic obstructive pulmonary disease: a meta-analysis of randomized controlled trials","volume":"85","author":"SY Park","year":"2022","journal-title":"Tuberc Respir Dis (Seoul)"},{"issue":"3","key":"pone.0328558.ref044","doi-asserted-by":"crossref","first-page":"272","DOI":"10.1037\/a0020462","article-title":"Reporting results of latent growth modeling and multilevel modeling analyses: some recommendations for rehabilitation psychology","volume":"55","author":"DL Jackson","year":"2010","journal-title":"Rehabil Psychol"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0328558","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,23]],"date-time":"2025-07-23T17:30:02Z","timestamp":1753291802000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0328558"}},"subtitle":[],"editor":[{"given":"Tai-Heng","family":"Chen","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2025,7,23]]},"references-count":44,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2025,7,23]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0328558","relation":{},"ISSN":["1932-6203"],"issn-type":[{"type":"electronic","value":"1932-6203"}],"subject":[],"published":{"date-parts":[[2025,7,23]]}}}