Evidence map›Paper›PMID 37696633›Full record

ArticleBMJ open2023

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 and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05726266 (Effect and Safety of Listening to Music or Audiobooks as a Coadjunvant Treatment for Chronic Pain Patients Under Opioid Treatment), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05726266 naunknown statusnot on this map

Effect and Safety of Listening to Music or Audiobooks as a Coadjunvant Treatment for Chronic Pain Patients Under Opioid Treatment: A Single-Center, Open-Label, Parallel Groups, Controlled, Randomized Pilot Clinical Trial

TypeinterventionalSponsorSebastian VidelaRan2023 to 2025Enrolled70ConditionsChronic PainArmsMusic, Audiobook
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Jennifer Grau-SánchezResearch Group on Complex Health Diagnoses and Interventions from Occupation and Care (OCCARE), Department of Occupational Therapy, University School of Nursing and Occupational Therapy of Terrassa (EUIT), Autonomous University of Barcelona, Terrassa, Spain.
Ancor SerranoPain Clinic, Department of Anaesthesia, Reanimation and Pain Management, Bellvitge University Hospital, Barcelona, Spain.
Jesús VilloriaNeuropharmacology & Pain Group, Neuroscience Program, Bellvitge Institute for Biomedical Research, Barcelona, Spain.ORCID 0000-0001-6508-9083
Thiago CarnavalNeuropharmacology & Pain Group, Neuroscience Program, Bellvitge Institute for Biomedical Research, Barcelona, Spain.ORCID 0000-0003-3353-5186
María F PortoCognition and Brain Plasticity Unit, Department of Cognition, Development and Educational Psychology, Faculty of Psychology, University of Barcelona and Bellvitge Institute for Biomedical Research (IDIBELL), Barcelona, Spain.
Lorena ZapataPharmacology Unit, Department of Pathology and Experimental Therapeutics, School of Medicine and Health Sciences, Institute of Neurosciences, Universitat de Barcelona, Barcelona, Spain.
Montse Flores-GarcíaPharmacology Unit, Department of Pathology and Experimental Therapeutics, School of Medicine and Health Sciences, Institute of Neurosciences, Universitat de Barcelona, Barcelona, Spain.
Emma SeguraCognition and Brain Plasticity Unit, Department of Cognition, Development and Educational Psychology, Faculty of Psychology, University of Barcelona and Bellvitge Institute for Biomedical Research (IDIBELL), Barcelona, Spain.
Jessica Garrido-PedrosaResearch Group on Complex Health Diagnoses and Interventions from Occupation and Care (OCCARE), Department of Occupational Therapy, University School of Nursing and Occupational Therapy of Terrassa (EUIT), Autonomous University of Barcelona, Terrassa, Spain.
Antoni Rodríguez-FornellsCognition and Brain Plasticity Unit, Department of Cognition, Development and Educational Psychology, Faculty of Psychology, University of Barcelona and Bellvitge Institute for Biomedical Research (IDIBELL), Barcelona, Spain.
Víctor Fernández-DueñasNeuropharmacology & Pain Group, Neuroscience Program, Bellvitge Institute for Biomedical Research, Barcelona, Spain.
Sebastian VidelaNeuropharmacology & Pain Group, Neuroscience Program, Bellvitge Institute for Biomedical Research, Barcelona, Spain svidelaces@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic 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.

Indexed as

Cancer PainChronic PainMusicAnalgesics, OpioidClinical Trials, Phase II as TopicHumansQuality of LifeRandomized Controlled Trials as TopicSound RecordingsTertiary Care CentersAnalgesics, OpioidChronic PainPain managementQuality of Life

Identifiers

PMID37696633
PMCPMC10496714

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.