Clinical trial NCT02436785: Do Inflammatory Arthritis Inpatients Receiving Group Music Therapy Improve Pain Compared to Music Listening?
Official title: Do Inflammatory Arthritis Inpatients Receiving Group Music Therapy Improve Pain Compared to Music Listening Over the 4 Weeks Using a Randomised Control Trial?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Rheumatoid
Spondylarthropathies
Arthritis, Psoriatic
Inflammatory Arthritis
Keywords: music therapy
pain management
self efficacy
patient education
relaxation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Mary Pack Research Fund
name: Vancouver Coastal Health Research Institute
First posted: 2015-05-07
Enrollment: 13
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of inflammatory arthritis
2. Admission to G F Strong Rehabilitation Center Arthritis Inpatient Program from the community or after joint replacement surgery
3. Between ages 16 and 85 years
4. Can speak, read and write in English

Exclusion Criteria:

1. Self-reported hearing loss
2. Clinician judgement of being unable to follow directions

Primary outcomes:
measure: Pain Scale rating (on Routine Assessment of Patient Index Data 3)
timeFrame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Secondary outcomes:
measure: Rheumatoid Arthritis Self-efficacy Scale (RASE)
timeFrame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
measure: 6 Minute Walk Test (6MWT)
timeFrame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
measure: Routine Assessment of Patient Index Data 3 (RAPID-3)
timeFrame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
measure: Canadian Occupational Performance Measures (COPM)
timeFrame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
measure: Pain Scale rating (on Routine Assessment of Patient Index Data 3)
timeFrame: one month after completion of intervention
measure: Rheumatoid Arthritis Self-efficacy Scale (RASE)
timeFrame: one month after completion of intervention
measure: 6 Minute Walk Test (6MWT)
timeFrame: one month after completion of intervention
measure: Routine Assessment of Patient Index Data 3 (RAPID-3)
timeFrame: one month after completion of intervention
measure: Canadian Occupational Performance Measures (COPM)
timeFrame: one month after completion of intervention
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: one month after completion of intervention
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: G F Strong Rehabilitation Centre
state: British Columbia
Study officials:
affiliation: G F Strong
name: Katherine M Wright, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Radner H, Ramiro S, Buchbinder R, Landewe RB, van der Heijde D, Aletaha D. Pain management for inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and other spondylarthritis) and gastrointestinal or liver comorbidity. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD008951. doi: 10.1002/14651858.CD008951.pub2.
citation: Heiberg T, Kvien TK. Preferences for improved health examined in 1,024 patients with rheumatoid arthritis: pain has highest priority. Arthritis Rheum. 2002 Aug;47(4):391-7. doi: 10.1002/art.10515.
citation: Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.
citation: Garza-Villarreal EA, Wilson AD, Vase L, Brattico E, Barrios FA, Jensen TS, Romero-Romo JI, Vuust P. Music reduces pain and increases functional mobility in fibromyalgia. Front Psychol. 2014 Feb 11;5:90. doi: 10.3389/fpsyg.2014.00090. eCollection 2014.
citation: Siedliecki SL, Good M. Effect of music on power, pain, depression and disability. J Adv Nurs. 2006 Jun;54(5):553-62. doi: 10.1111/j.1365-2648.2006.03860.x.
citation: Bagheri-Nesami M, Mohseni-Bandpei MA, Shayesteh-Azar M. The effect of Benson Relaxation Technique on rheumatoid arthritis patients: extended report. Int J Nurs Pract. 2006 Aug;12(4):214-9. doi: 10.1111/j.1440-172X.2006.00568.x.
citation: Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.
citation: Dager TN, Kjeken I, Fjerstad E, Hauge MI. "It is about taking grips and not let myself be ravaged by my body": a qualitative study of outcomes from in-patient multidisciplinary rehabilitation for patients with chronic rheumatic diseases. Disabil Rehabil. 2012;34(11):910-6. doi: 10.3109/09638288.2011.626485. Epub 2011 Nov 8.
citation: Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.