Story Kristin M, Bravata Dawn M, Robb Sheri L, Wasmuth Sally, Slaven James E, Whitmire Leah, Barker Barry, Menen Tetla, Bair Matthew J
Center for Health Information and Communication (CHIC), Health Services Research & Development (HSRD), Richard L Roudebush Veterans Affairs Medical Center, Indianapolis, IN, United States.
Expanding Expertise through E-health Network Development (EXTEND) Quality Enhancement Research Initiative (QUERI), Veterans Affairs Health Services Research and Development (HSR&D), Indianapolis, IN, United States.
JMIR Res Protoc. 2022 Sep 22;11(9):e38788. doi: 10.2196/38788.
Chronic pain and access to care are identified as critical needs of the Veterans Health Administration. Music imagery and music listening interventions have shown promise as effective nonpharmacological options for pain management. However, most studies have focused on acute pain, passive music experiences, and in-person delivery.
In this study, we aimed to examine the feasibility and acceptability of 2 music interventions delivered through telehealth for chronic musculoskeletal pain, trial design, and theoretical model before conducting a fully powered efficacy or comparative effectiveness trial.
FAMILIA (Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia) is a 3-arm, parallel group, pilot trial. A total of 60 veterans will be randomized to one of the three conditions: music imagery, music listening, or usual care. Aim 1 is to test the feasibility and acceptability of a multicomponent, interactive music imagery intervention (8-weekly, individual sessions) and a single-component, minimally interactive music learning intervention (independent music listening). Feasibility metrics related to recruitment, retention, engagement, and completion of the treatment protocol and questionnaires will be assessed. Up to 20 qualitative interviews will be conducted to assess veteran experiences with both interventions, including perceived benefits, acceptability, barriers, and facilitators. Interview transcripts will be coded and analyzed for emergent themes. Aim 2 is to explore the effects of music imagery and music listening versus usual care on pain and associated patient-centered outcomes. These outcomes and potential mediators will be explored through changes from baseline to follow-up assessments at 1, 3, and 4 months. Descriptive statistics will be used to describe outcomes; this pilot study is not powered to detect differences in outcomes.
Recruitment for FAMILIA began in March 2022, and as of July 2022, 16 participants have been enrolled. We anticipate that enrollment will be completed by May 2023. We expect that music imagery and music listening will prove acceptable to veterans and that feasibility benchmarks will be reached. We hypothesize that music imagery and music listening will be more effective than usual care on pain and related outcomes.
FAMILIA addresses four limitations in music intervention research for chronic pain: limited studies in veterans, evaluation of a multicomponent music intervention, methodological rigor, and internet-based delivery. Findings from FAMILIA will inform a fully powered trial to identify putative mechanisms and test efficacy.
ClinicalTrials.gov NCT05426941; https://tinyurl.com/3jdhx28u.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38788.
慢性疼痛和获得医疗服务被确定为退伍军人健康管理局的关键需求。音乐意象和音乐聆听干预已显示出作为疼痛管理有效非药物选择的前景。然而，大多数研究集中在急性疼痛、被动音乐体验和面对面实施上。
在本研究中，我们旨在通过远程医疗为慢性肌肉骨骼疼痛提供两种音乐干预措施，在进行全面的疗效或比较效果试验之前，先考察其可行性和可接受性、试验设计以及理论模型。
FAMILIA（音乐意象和聆听干预镇痛的可行性和可接受性）是一项三臂平行组试点试验。总共60名退伍军人将被随机分配到以下三种情况之一：音乐意象、音乐聆听或常规护理。目标1是测试多成分、交互式音乐意象干预（每周一次，共8次，个体疗程）和单成分、最低限度交互式音乐学习干预（自主音乐聆听）的可行性和可接受性。将评估与招募、留存、参与以及治疗方案和问卷完成情况相关的可行性指标。将进行多达20次定性访谈，以评估退伍军人对这两种干预措施的体验，包括感知到的益处、可接受性、障碍和促进因素。访谈记录将进行编码并分析以找出新出现的主题。目标2是探讨音乐意象和音乐聆听与常规护理相比对疼痛及以患者为中心的相关结局的影响。这些结局和潜在中介因素将通过在1个月、3个月和4个月时从基线到随访评估的变化来探讨。将使用描述性统计来描述结局；本试点研究无能力检测结局的差异。
FAMILIA的招募工作于2022年3月开始，截至2022年7月，已招募了16名参与者。我们预计招募工作将于2023年5月完成。我们预计音乐意象和音乐聆听将被退伍军人接受，并将达到可行性基准。我们假设音乐意象和音乐聆听在疼痛及相关结局方面将比常规护理更有效。
FAMILIA解决了慢性疼痛音乐干预研究中的四个局限性：退伍军人中的研究有限、多成分音乐干预的评估、方法的严谨性以及基于互联网的实施。FAMILIA的研究结果将为一项全面的试验提供信息，以确定假定机制并测试疗效。
ClinicalTrials.gov NCT05426941；https://tinyurl.com/3jdhx2DU。
国际注册报告识别码（IRRID）：DERR1-10.2196/38788。
