Feasibility and Acceptability of Music Imagery and Listening Interventions for Analgesia: Protocol for a Randomized Controlled Trial.
acceptability
chronic pain
clinical trial
feasibility
mobile phone
music imagery
music therapy
pilot study
veterans
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
22 Sep 2022
22 Sep 2022
Historique:
received:
14
07
2022
accepted:
30
07
2022
revised:
27
07
2022
entrez:
22
9
2022
pubmed:
23
9
2022
medline:
23
9
2022
Statut:
epublish
Résumé
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. DERR1-10.2196/38788.
Sections du résumé
BACKGROUND
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
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
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
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
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
BACKGROUND
ClinicalTrials.gov NCT05426941; https://tinyurl.com/3jdhx28u.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/38788.
Identifiants
pubmed: 36136377
pii: v11i9e38788
doi: 10.2196/38788
pmc: PMC9539652
doi:
Banques de données
ClinicalTrials.gov
['NCT05426941']
Types de publication
Journal Article
Langues
eng
Pagination
e38788Informations de copyright
©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.
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