慢性非癌性疼痛（CNCP）的治疗主要目标是在改善生活质量的同时，保持身心功能。近年来，CNCP患者使用阿片类药物的情况有所增加，同时提出了非药物干预手段，如听音乐，以对抗其影响。与其他听觉刺激不同，音乐可以激活情绪调节和奖励调节回路，这使其具备改变注意过程和调节情绪的潜力。本研究的主要目标是首次提供有关音乐听力作为辅助维持镇痛治疗在进行阿片镇痛药治疗的CNCP患者中的独特效应的证据。本研究将是一项单中心、II期、开放标签、平行组、概念证明的随机临床试验，参与患者均为长期使用阿片剂治疗的CNCP患者，至少疗程4周。我们计划纳入70例连续患者，随机分为实验组（主动听音乐）和对照组（主动听有声读物），两组均在28天内每日听音乐或有声读物，时间为至少30分钟至1小时，所选曲目将根据个体偏好进行调整。将描述并比较每次访视的疼痛强度评分、与基线值的变化以及根据疼痛强度变化的不同定义确定的反应者比例，以评估和比较研究组间的结果演变，我们将应用纵向数据评估方法（混合广义线性模型），以患者为群集进行评估。我们还将使用中介分析框架，以调整其他治疗措施的影响，并获得具有因果解释的效果估计。该研究方案已经完成审查，并获得来自巴塞罗那西披瓦格大学医院机构审查委员会的伦理批准。本研究的结果将通过论文出版和会议展示进行积极传播。NCT05726266. ©作者（或其雇主）2023。根据CC BY-NC进行再利用，不得进行商业再利用。由BMJ出版。

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.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.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.NCT05726266.© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.