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Effect and safety of listening to music or audiobooks as a coadjuvant treatment for chronic pain patients under opioid treatment : a study protocol for an open-label, parallel-group, randomised, controlled, proof-of-concept clinical trial in a tertiary hospital in the Barcelona South Metropolitan area / Jennifer Grau-Sánchez, Ancor Serrano, Jesús Villoria, Thiago Carnaval, María F Porto, Lorena Zapata, Montse Flores-García, Emma Segura, Jessica Garrido-Pedrosa, Antoni Rodríguez-Fornells, Víctor Fernández-Dueñas, Sebastian Videla

Creator: Grau-Sánchez, Jennifer, https://orcid.org/0000-0002-8123-1745 [autor].
Creators: Serrano, Ancor [autor] | Villoria, Jesús [autor] | Carnaval, Thiago [autor] | Porto, María F [autor] | Zapata, Lorena [autor] | Flores-García, Montse [autor] | Segura, Emma [autor] | Garrido-Pedrosa, Jèssica, https://orcid.org/0000-0002-2550-7727 [autor] | Rodríguez-Fornells, Antoni [autor] | Fernández-Dueñas, Víctor [autor] | Videla, Sebastià [autor] | Escola Universitària d’Infermeria i Teràpia Ocupacional de Terrassa. OCCARE Research Group.
Material type: ArticleArticleContent type: text Media type: informàtic Carrier type: recurs en líniaNew identifier: doi: https://dx.doi.org/10.1136/bmjopen-2023-074948Subject(s): Música | Audiollibres | Musicoteràpia | Dolor crònic | Tractament | Hospitals | Assaig clínic aleatoritzat i de control | Professors -- EUIT | Barcelona (Catalunya) | Listening to music | Audiobooks | Chronic pain | Rehabilitation | Opioid treatment | Tertiary hospital | Música | Audiolibros | Dolor crónico | Rehabilitación | Tratamiento farmacológico | Hospital terciarioGenre/Form: info:eu-repo/semantics/article | info:eu-repo/semantics/publishedVersionOnline resources: Enllaç permanent | Accés lliure pdf | Accés lliure (adreça alternativa) | Google Acadèmic: Cites | Revista: Mètriques In: BMJ Open 2023 Sep 11;13:e074948.Summary: Background Chronic non-cancer pain (CNCP) treatment’s primary goal is to maintain physical and mental functioning while improving quality of life. Opioid use in CNCP patients has increased in recent years, and non-pharmacological interventions such as music listening have been proposed to counter it. Unlike other auditive stimuli, music can activate emotional-regulating and reward-regulating circuits, making it a potential tool to modulate attentional processes and regulate mood. This study’s primary objective is to provide the first evidence on the distinct (separate) effects of music listening as a coadjuvant maintenance analgesic treatment in CNCP patients undergoing opioid analgesia. Methods and analysis This will be a single-centre, phase II, open-label, parallel-group, proof-of-concept randomised clinical trial with CNCP patients under a minimum 4-week regular opioid treatment. We plan to include 70 consecutive patients, which will be randomised (1:1) to either the experimental group (active music listening) or the control group (active audiobooks listening). During 28 days, both groups will listen daily (for at least 30 min and up to 1 hour) to preset playlists tailored to individual preferences. Pain intensity scores at each visit, the changes (differences) from baseline and the proportions of responders according to various definitions based on pain intensity differences will be described and compared between study arms. We will apply longitudinal data assessment methods (mixed generalised linear models) taking the patient as a cluster to assess and compare the endpoints’ evolution. We will also use the mediation analysis framework to adjust for the effects of additional therapeutic measures and obtain estimates of effect with a causal interpretation. Ethics and dissemination The study protocol has been reviewed, and ethics approval has been obtained from the Bellvitge University Hospital Institutional Review Board, L’Hospitalet de Llobregat, Barcelona, Spain. The results from this study will be actively disseminated through manuscript publications and conference presentations. Trial registration number NCT05726266.
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Item type Current library Collection Call number URL Status Date due Barcode
Journal article Journal article Dipòsit Digital EUIT Internet En línia Text complet Not for loan 0010173132880
Journal Journal Escola Universitària d'Infermeria i Teràpia Ocupacional de Terrassa Internet En línia Not for loan 101552874

Grau-Sánchez J, Serrano A, Villoria J, et al. Effect and safety of listening to music or audiobooks as a coadjuvant treatment for chronic pain patients under opioid treatment: a study protocol for an open-label, parallel-group, randomised, controlled, proof-of-concept clinical trial in a tertiary hospital in the Barcelona South Metropolitan area. BMJ Open2023;13:e074948. doi:10.1136/bmjopen-2023-074948

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