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Completed

NCT Number: NCT02436785

Do Inflammatory Arthritis Inpatients Receiving Group Music Therapy Improve Pain Compared to Music Listening?

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.

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Key information

About this study

  • 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.

  • 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.
  • 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.

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Self-reported hearing loss
  • Clinician judgement of being unable to follow directions

Treatment and study plan

Music Therapy

Other

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.

Music listening

Other

Listening to relaxing music on a CD player for approximately an hour.

Primary outcomes

  1. Pain Scale rating (on Routine Assessment of Patient Index Data 3)

    Time frame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks

    Numeric pain rating from 0 to 10 with 0.5 increment

Secondary outcomes

  1. Rheumatoid Arthritis Self-efficacy Scale (RASE)

    Time frame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks

    Self-reported questionnaire rating on self-efficacy in the areas of pain management, fatigue management, stress management, joint protection and management of activities of daily living.

  2. 6 Minute Walk Test (6MWT)

    Time frame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks

    Objective measurement of walking endurance in 6 minutes.

  3. Routine Assessment of Patient Index Data 3 (RAPID-3)

    Time frame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks

    Subjective questionnaire on performance level of activities of daily living.

  4. Canadian Occupational Performance Measures (COPM)

    Time frame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks

    Subjective report on performance level of activities of daily living and self reported satisfaction level

  5. Center for Epidemiological Studies Depression Scale (CES-D)

    Time frame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks

    self reported questionnaire on frequency of experiencing depression symptoms.

  6. Pain Scale rating (on Routine Assessment of Patient Index Data 3)

    Time frame: one month after completion of intervention

    Numeric pain rating from 0 to 10 with 0.5 increment

  7. Rheumatoid Arthritis Self-efficacy Scale (RASE)

    Time frame: one month after completion of intervention

    Self-reported questionnaire rating on self-efficacy in the areas of pain

  8. 6 Minute Walk Test (6MWT)

    Time frame: one month after completion of intervention

    Objective measurement of walking endurance in 6 minutes.

  9. Routine Assessment of Patient Index Data 3 (RAPID-3)

    Time frame: one month after completion of intervention

    Subjective questionnaire on performance level of activities of daily living.

  10. Canadian Occupational Performance Measures (COPM)

    Time frame: one month after completion of intervention

    self reported questionnaire on frequency of experiencing depression symptoms.

  11. Center for Epidemiological Studies Depression Scale (CES-D)

    Time frame: one month after completion of intervention

    self reported questionnaire on frequency of experiencing depression symptoms.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Mary Pack Research Fund
  • Vancouver Coastal Health Research Institute

Registry information

Official study title

Do Inflammatory Arthritis Inpatients Receiving Group Music Therapy Improve Pain Compared to Music Listening Over the 4 Weeks Using a Randomised Control Trial?

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 7, 2015
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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