Do Inflammatory Arthritis Inpatients Receiving Group Music Therapy Improve Pain Compared to Music Listening?
Condition: Arthritis, Rheumatoid; Spondylarthropathies; Arthritis, Psoriatic; Inflammatory Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthropathies
Study type: Interventional

Summary: 
      Pain management is rated by patients with inflammatory arthritis as the highest priority in
      their disease treatment. Past research showed that music therapy is associated with reduced
      pain and depression. The purpose of this study is to better understand the effectiveness of
      music therapy for people with inflammatory arthritis. Participants will be randomly assigned
      to: 1) Music Therapy group facilitated by a music therapist, or 2) Music Listening group that
      listens to a relaxation CD (compact disc). Standardized tests will determine if participating
      in music therapy group helps reduce pain and depression, improve physical function and
      confidence levels in applying self-management strategies.
    

Detailed description: 
      1. Purpose:

           To better understand the effectiveness of music therapy for people with inflammatory
           arthritis. Determine if participating in a music therapy group facilitated by a music
           therapist helps reduce pain and depression, and improve physical function and
           self-efficacy.

           No optional studies are currently planned.

        2. Hypothesis Participants in the Music Therapy group will report less pain than those in
           the Music Listening group after the intervention phase. Music Therapy will also be
           associated with improvement in secondary outcomes including physical functioning,
           self-efficacy, and depression.

        3. Justification G F Strong Rehabilitation Center Arthritis Inpatient Program has an
           interdisciplinary approach to pain management: education, medical management,
           physiotherapy interventions such as exercises and use of physical agents (i.e. heat,
           cold, electrotherapy, ultrasound), occupational therapy intervention (i.e. activity
           modification and use of adaptive devices), and social work, dietician, psychology and
           pharmacy services. Current standard of care has limitations; it insufficiently addresses
           emotional aspects of chronic pain management. It also introduces relaxation strategies
           in a didactic module but does not provide training and opportunity to practice these
           strategies with the support of a health care professional. The Music Therapy
           intervention group is facilitated by a music therapist. Music therapists are trained to
           manipulate elements of music to achieve desired effects during music therapy
           interventions. These elements, such as beat, tempo (speed), or pitch level, can trigger
           adaptive neurophysiological, psychophysiological, emotional and behavioural responses.
           The Music Therapy group offers a chance to practice pain management and relaxation
           strategies, increase a sense of social cohesion and reduce a sense of isolation that
           individuals may experience when dealing with chronic pain. Participants in the control
           Music Listening group will listen to a relaxation CD.

           Past research showed that music therapy and music listening are associated with reduced
           pain intensity levels, increased functional mobility, and reduced depression. There was
           no clear research found on group music therapy's effectiveness on people with
           inflammatory arthritis. This feasibility study will help to better understand the
           effectiveness of music therapy for people with inflammatory arthritis.

        4. Objectives

           Outcome measures to be collected include:

             -  Category Rating Scale for Pain (from RAPID-3)

             -  Rheumatoid Arthritis Self-efficacy Scale (RASE)

             -  6 Minute Walk Test (6MWT)

             -  Routine Assessment of Patient Index Data 3 (RAPID-3)

             -  Canadian Occupational Performance Measures (COPM)

             -  Center for Epidemiological Studies Depression Scale (CES-D) Data will be collected
                on three occasions: 1) time of enrollment, 2) after attending Music Therapy or
                Music Listening sessions, and 3) one month after completion of intervention.

        5. Research Method

             -  Target population: patients with inflammatory arthritis admitted to G F Strong
                Rehabilitation Center Inpatient Arthritis program

             -  Sampling method: participants will be stratified into 4 groups and randomized using
                a 1:1 allocation ratio into 2 groups: Music Therapy and Music Listening. 40
                patients are expected to enroll during recruiting time from April to September in
                2015.

             -  Research design: Parallel group feasibility randomized controlled trial with a
                dose-matched active comparator.

        6. Statistical Analysis Statistical software such as R, Minitab and Cytel Studio will be
           used to create descriptive statistics such as means and standard deviations; medians and
           interquartile ranges, minima, and maxima. A CONSORT flow chart will be constructed to
           show any losses during the trial, and imputation methods will be used to study the
           impact of missingness on any of the estimates and conclusions. Statistical models for
           each outcome variable will be used to measure the effect of Music Therapy compared to
           Music Listening group. Model assumptions such as independence of observations, normality
           of residuals and homogeneity of variance to validate the statistical analyses will be
           conducted.
    

Intervention name(s): Music Therapy; Music Listening
Intervention type(s): Other; Other
Intervention description(s): In-vivo relaxation where the live music is manipulated in terms of speed and intensity to bring on a state of relaxation for approximately an hour. There will be a brief therapist-led discussion before and after the relaxation portion to increase a sense of group cohesion. Procedures that will be used are based on evidence-based practice for trained Music Therapists.; Listening to relaxing music on a CD player for approximately an hour.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: music therapy; pain management; self efficacy; patient education; relaxation