Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia: Protocol for a Randomized Controlled Trial

Kristin M Story, Dawn M Bravata, Sheri L Robb, Sally Wasmuth, James E Slaven, Leah Whitmire, Barry Barker, Tetla Menen, Matthew J Bair, Kristin M Story, Dawn M Bravata, Sheri L Robb, Sally Wasmuth, James E Slaven, Leah Whitmire, Barry Barker, Tetla Menen, Matthew J Bair

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT05426941; https://tinyurl.com/3jdhx28u.

International registered report identifier (irrid): DERR1-10.2196/38788.

Keywords: acceptability; chronic pain; clinical trial; feasibility; mobile phone; music imagery; music therapy; pilot study; veterans.

Conflict of interest statement

Conflicts of Interest: None declared.

©Kristin M Story, Dawn M Bravata, Sheri L Robb, Sally Wasmuth, James E Slaven, Leah Whitmire, Barry Barker, Tetla Menen, Matthew J Bair. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 22.09.2022.

Figures

Figure 1
Figure 1
Study conceptual framework. MI: music imagery; ML: music listening; PTSD: posttraumatic stress disorder.
Figure 2
Figure 2
Flowchart of study design.
Figure 3
Figure 3
Music imagery intervention steps. MI: music imagery.

References

    1. Dahlhamer J, Lucas J, Zelaya C, Nahin R, Mackey S, DeBar L, Kerns R, Von Korff M, Porter L, Helmick C. Prevalence of chronic pain and high-impact chronic pain among adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001–6. doi: 10.15585/mmwr.mm6736a2. doi: 10.15585/mmwr.mm6736a2.
    1. Nahin RL. Severe pain in veterans: the effect of age and sex, and comparisons with the general population. J Pain. 2017 Mar;18(3):247–54. doi: 10.1016/j.jpain.2016.10.021. S1526-5900(16)30313-3
    1. Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education . Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC, USA: National Academies Press (US); 2011.
    1. Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006–17. doi: 10.1016/S0140-6736(20)32340-0. S0140-6736(20)32340-0
    1. Vallerand AH, Cosler P, Henningfield JE, Galassini P. Pain management strategies and lessons from the military: a narrative review. Pain Res Manag. 2015;20(5):261–8. doi: 10.1155/2015/196025. doi: 10.1155/2015/196025.
    1. VHA Directive 2009-053: Pain Management. Department of Veteran Affairs. 2009. Oct 28, [2022-02-28]. .
    1. Bradt J, Dileo C, Potvin N. Music for stress and anxiety reduction in coronary heart disease patients. Cochrane Database Syst Rev. 2013 Dec 28;2013(12):CD006577. doi: 10.1002/14651858.CD006577.pub3.
    1. Bradt J, Dileo C, Myers-Coffman K, Biondo J. Music interventions for improving psychological and physical outcomes in people with cancer. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD006911. doi: 10.1002/14651858.CD006911.pub4.
    1. Garza-Villarreal EA, Pando V, Vuust P, Parsons C. Music-induced analgesia in chronic pain conditions: a systematic review and meta-analysis. Pain Physician. 2017 Nov;20(7):597–610.
    1. Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659–71. doi: 10.1016/S0140-6736(15)60169-6.S0140-6736(15)60169-6
    1. Lee JH. The effects of music on pain: a meta-analysis. J Music Ther. 2016;53(4):430–77. doi: 10.1093/jmt/thw012.thw012
    1. Yangöz ŞT, Özer Z. The effect of music intervention on patients with cancer-related pain: a systematic review and meta-analysis of randomized controlled trials. J Adv Nurs. 2019 Dec;75(12):3362–73. doi: 10.1111/jan.14184.
    1. Lin CL, Hwang SL, Jiang P, Hsiung NH. Effect of music therapy on pain after orthopedic surgery-a systematic review and meta-analysis. Pain Pract. 2020 Apr;20(4):422–36. doi: 10.1111/papr.12864.
    1. Blichfeldt-Ærø SC, Trondalen G, Halvorsen S. Facilitated music listening: music therapy in an invasive cardiac procedure. Br J Music Ther. 2019 Apr 05;33(1):27–38. doi: 10.1177/1359457519840131.
    1. Grocke DE, Wigram T. Receptive Methods in Music Therapy: Techniques and Clinical Applications for Music Therapy Clinicians, Educators and Students. Philadelphia, PA, USA: Jessica Kingsly Publishsers; 2006.
    1. Beck BD, Messel C, Meyer SL, Cordtz TO, Søgaard U, Simonsen E, Moe T. Feasibility of trauma-focused Guided Imagery and Music with adult refugees diagnosed with PTSD: a pilot study. Nordic J Music Ther. 2018;27(1):67–86. doi: 10.1080/08098131.2017.1286368.
    1. Story KM, Beck BD. Guided Imagery and Music with female military veterans: an intervention development study. Arts Psychother. 2017 Sep;55:93–102. doi: 10.1016/j.aip.2017.05.003.
    1. Grocke D, Moe T. Guided Imagery and Music (GIM) and Music Imagery Methods for Individual and Group Therapy. Philadelphia, PA, USA: Jessica Kingsley Publishers; 2015.
    1. Heiderscheit A, Chlan L, Donley K. Instituting a music listening intervention for critically ill patients receiving mechanical ventilation: exemplars from two patient cases. Music Med. 2011 Oct 01;3(4):239–46. doi: 10.1177/1943862111410981.
    1. Torres E, Pedersen IN, Pérez-Fernández JI. Randomized trial of a group music and imagery method (GrpMI) for women with fibromyalgia. J Music Ther. 2018 Jun 07;55(2):186–220. doi: 10.1093/jmt/thy005.4999326
    1. Linnemann A, Kappert MB, Fischer S, Doerr JM, Strahler J, Nater UM. The effects of music listening on pain and stress in the daily life of patients with fibromyalgia syndrome. Front Hum Neurosci. 2015 Jul 30;9:434. doi: 10.3389/fnhum.2015.00434. doi: 10.3389/fnhum.2015.00434.
    1. Batt-Rawden KB, DeNora T, Ruud E. Music listening and empowerment in health promotion: a study of the role and significance of music in everyday life of the long-term ill. Nordic J Music Ther. 2005 Jul;14(2):120–36. doi: 10.1080/08098130509478134.
    1. Levy CE, Spooner H, Lee JB, Sonke J, Myers K, Snow E. Telehealth-based creative arts therapy: transforming mental health and rehabilitation care for rural veterans. Arts Psychother. 2018 Feb;57:20–6. doi: 10.1016/j.aip.2017.08.010.
    1. Moffatt JJ, Eley DS. The reported benefits of telehealth for rural Australians. Aust Health Rev. 2010 Aug;34(3):276–81. doi: 10.1071/AH09794.AH09794
    1. Luptak M, Dailey N, Juretic M, Rupper R, Hill RD, Hicken BL, Bair BD. The Care Coordination Home Telehealth (CCHT) rural demonstration project: a symptom-based approach for serving older veterans in remote geographical settings. Rural Remote Health. 2010;10(2):1375. 1375
    1. Vaudreuil R, Langston DG, Magee WL, Betts D, Kass S, Levy C. Implementing music therapy through telehealth: considerations for military populations. Disabil Rehabil Assist Technol. 2022 Feb;17(2):201–10. doi: 10.1080/17483107.2020.1775312.
    1. Howlin C, Rooney B. The cognitive mechanisms in music listening interventions for pain: a scoping review. J Music Ther. 2020 May 02;57(2):127–67. doi: 10.1093/jmt/thaa003.5816307
    1. Martin-Saavedra JS, Vergara-Mendez LD, Talero-Gutiérrez C. Music is an effective intervention for the management of pain: an umbrella review. Complement Ther Clin Pract. 2018 Aug;32:103–14. doi: 10.1016/j.ctcp.2018.06.003.S1744-3881(18)30141-5
    1. Robb SL, Burns DS, Carpenter JS. Reporting guidelines for music-based interventions. J Health Psychol. 2011 Mar;16(2):342–52. doi: 10.1177/1359105310374781. 1359105310374781
    1. Story KM, Robb SL, Preddie A, Flanagan M, Damush TM. Service delivery adaptations: telehealth creative arts therapy in the veterans health administration. Proceedings of the AMIA 2021 Annual Symposium; AMIA '21; October 30-November 3, 2021; San Diego, CA, USA. 2021.
    1. Gately ME, Tickle-Degnen L, Voydetich DJ, Ward N, Ladin K, Moo LR. Video telehealth occupational therapy services for older veterans: national survey study. JMIR Rehabil Assist Technol. 2021 Apr 27;8(2):e24299. doi: 10.2196/24299. v8i2e24299
    1. Landes SJ, Pitcock JA, Harned MS, Connolly SL, Meyers LL, Oliver CM. Provider perspectives on delivering dialectical behavior therapy via telehealth during COVID-19 in the Department of Veterans Affairs. Psychol Serv. 2022 Aug;19(3):562–72. doi: 10.1037/ser0000571.2021-70917-001
    1. Lightstone AJ, Bailey SK, Voros P. Collaborative music therapy via remote video technology to reduce a veteran's symptoms of severe, chronic PTSD. Arts Health. 2015 Apr 19;7(2):123–36. doi: 10.1080/17533015.2015.1019895.
    1. Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626–9. doi: 10.1016/j.jpsychires.2010.10.008. S0022-3956(10)00292-X
    1. Kroenke K, Bair MJ, Damush TM, Wu J, Hoke S, Sutherland J, Tu W. Optimized antidepressant therapy and pain self-management in primary care patients with depression and musculoskeletal pain: a randomized controlled trial. JAMA. 2009 May 27;301(20):2099–110. doi: 10.1001/jama.2009.723. 301/20/2099
    1. Kroenke K, Krebs EE, Wu J, Yu Z, Chumbler NR, Bair MJ. Telecare collaborative management of chronic pain in primary care: a randomized clinical trial. JAMA. 2014 Jul 16;312(3):240–8. doi: 10.1001/jama.2014.7689.1887761
    1. Bair MJ, Ang D, Wu J, Outcalt SD, Sargent C, Kempf C, Froman A, Schmid AA, Damush TM, Yu Z, Davis LW, Kroenke K. Evaluation of Stepped Care for Chronic Pain (ESCAPE) in veterans of the Iraq and Afghanistan conflicts: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):682–9. doi: 10.1001/jamainternmed.2015.97.2174941
    1. Krebs EE, Gravely A, Nugent S, Jensen AC, DeRonne B, Goldsmith ES, Kroenke K, Bair MJ, Noorbaloochi S. Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA. 2018 Mar 06;319(9):872–82. doi: 10.1001/jama.2018.0899. 2673971
    1. Trondalen G, Bonde LO. Music therapy: models and interventions. In: MacDonald R, Kreutz G, Mitchell L, editors. Music, Health, and Wellbeing. Oxford, UK: Oxford University Press; 2012. pp. 40–62.
    1. Summer L. The journey of GIM training from self-exploration to a continuum of clinical practice. In: Grocke DE, Moe T, editors. Guided Imagery & Music (GIM) and Music Imagery Methods for Individual and Group Therapy. Philadelphia, PA, USA: Jessica Kingsley Publishers; 2015. pp. 339–48.
    1. Sturgeon JA, Zautra AJ. Psychological resilience, pain catastrophizing, and positive emotions: perspectives on comprehensive modeling of individual pain adaptation. Curr Pain Headache Rep. 2013 Mar;17(3):317. doi: 10.1007/s11916-012-0317-4.
    1. Batt-Rawden KB. The benefits of self-selected music on health and well-being. Arts Psychother. 2010 Sep;37(4):301–10. doi: 10.1016/j.aip.2010.05.005.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606–13. doi: 10.1046/j.1525-1497.2001.016009606.x. jgi01114
    1. Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266–77. doi: 10.1176/appi.ajp.2011.10111704.
    1. Laguado SA, Steavenson R, Mehvar M. Areas of improvement in suicide risk identification, assessment, and risk mitigation documentation by mental health prescribers at a veterans affairs health care system. Adm Policy Ment Health. 2021 Jul;48(4):633–8. doi: 10.1007/s10488-020-01097-0.10.1007/s10488-020-01097-0
    1. Munder T, Wilmers F, Leonhart R, Linster HW, Barth J. Working Alliance Inventory-Short Revised (WAI-SR): psychometric properties in outpatients and inpatients. Clin Psychol Psychother. 2010;17(3):231–9. doi: 10.1002/cpp.658.
    1. Rees C, Craigie M, Slatyer S, Heritage B, Harvey C, Brough P, Hegney D. Mindful Self-Care and Resiliency (MSCR): protocol for a pilot trial of a brief mindfulness intervention to promote occupational resilience in rural general practitioners. BMJ Open. 2018 Jun 30;8(6):e021027. doi: 10.1136/bmjopen-2017-021027. bmjopen-2017-021027
    1. Wilcox S, Schoffman DE, Dowda M, Sharpe PA. Psychometric properties of the 8-item english arthritis self-efficacy scale in a diverse sample. Arthritis. 2014;2014:385256. doi: 10.1155/2014/385256. doi: 10.1155/2014/385256.
    1. Farrar JT, Young Jr JP, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149–58. doi: 10.1016/S0304-3959(01)00349-9.00006396-200111000-00006
    1. Mendoza T, Mayne T, Rublee D, Cleeland C. Reliability and validity of a modified Brief Pain Inventory short form in patients with osteoarthritis. Eur J Pain. 2006 May;10(4):353–61. doi: 10.1016/j.ejpain.2005.06.002.S1090-3801(05)00078-9
    1. Walton DM, Mehta S, Seo W, MacDermid JC. Creation and validation of the 4-item BriefPCS-chronic through methodological triangulation. Health Qual Life Outcomes. 2020 May 07;18(1):124. doi: 10.1186/s12955-020-01346-8. 10.1186/s12955-020-01346-8
    1. Nicolaidis C, Chianello T, Gerrity M. Development and preliminary psychometric testing of the centrality of pain scale. Pain Med. 2011 Apr;12(4):612–7. doi: 10.1111/j.1526-4637.2011.01072.x.
    1. Scott W, McCracken LM. Patients' impression of change following treatment for chronic pain: global, specific, a single dimension, or many? J Pain. 2015 Jun;16(6):518–26. doi: 10.1016/j.jpain.2015.02.007.S1526-5900(15)00544-1
    1. Cella D, Choi SW, Condon DM, Schalet B, Hays RD, Rothrock NE, Yount S, Cook KF, Gershon RC, Amtmann D, DeWalt DA, Pilkonis PA, Stone AA, Weinfurt K, Reeve BB. PROMIS ® adult health profiles: efficient short-form measures of seven health domains. Value Health. 2019 May;22(5):537–44. doi: 10.1016/j.jval.2019.02.004. S1098-3015(19)30118-4
    1. Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092–7. doi: 10.1001/archinte.166.10.1092.166/10/1092
    1. Prins A, Bovin MJ, Smolenski DJ, Marx BP, Kimerling R, Jenkins-Guarnieri MA, Kaloupek DG, Schnurr PP, Kaiser AP, Leyva YE, Tiet QQ. The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): development and evaluation within a veteran primary care sample. J Gen Intern Med. 2016 Oct;31(10):1206–11. doi: 10.1007/s11606-016-3703-5. 10.1007/s11606-016-3703-5
    1. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385–96.
    1. Garratt AM, Furunes H, Hellum C, Solberg T, Brox JI, Storheim K, Johnsen LG. Evaluation of the EQ-5D-3L and 5L versions in low back pain patients. Health Qual Life Outcomes. 2021 May 28;19(1):155. doi: 10.1186/s12955-021-01792-y. 10.1186/s12955-021-01792-y
    1. Holden L, Lee C, Hockey R, Ware RS, Dobson AJ. Validation of the MOS Social Support Survey 6-item (MOS-SSS-6) measure with two large population-based samples of Australian women. Qual Life Res. 2014 Dec;23(10):2849–53. doi: 10.1007/s11136-014-0741-5.
    1. SAS Institute . SAS 9. 4 Output Delivery System: User's Guide. 3rd Edition. Cary, NC, USA: SAS Institute; 2014.
    1. Muthén LK, Muthén BO. Mplus: statistical analyses with latent variables: user's guide. 8th edition. Muthén and Muthén. 2017. [2022-02-28]. .
    1. Braun V, Clarke V. Thematic analysis. In: Cooper H, Camic PM, Long DL, Panter AT, Rindskopf D, Sher KJ, editors. APA Handbook of Research Methods in Psychology. Volume 2. Research Designs: Quantitative, Qualitative, Neuropsychological, and Biological. Washington, DC, USA: American Psychological Association; 2012. pp. 57–71.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi