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

Primary Purpose

Arthritis, Rheumatoid, Spondylarthropathies, Arthritis, Psoriatic

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Music Therapy
Music Listening
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring music therapy, pain management, self efficacy, patient education, relaxation

Eligibility Criteria

16 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • G F Strong Rehabilitation Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Music Therapy

Music Listening

Arm Description

The music therapy group will run for approximately an hour (twice a week) and will involve in-vivo relaxation where the live music is manipulated in terms of speed and intensity to bring on a state of relaxation. 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.

The control group will also run for approximately an hour (twice a week) and will involve listening to relaxing music on a CD player.

Outcomes

Primary Outcome Measures

Pain Scale rating (on Routine Assessment of Patient Index Data 3)
Numeric pain rating from 0 to 10 with 0.5 increment

Secondary Outcome Measures

Rheumatoid Arthritis Self-efficacy Scale (RASE)
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.
6 Minute Walk Test (6MWT)
Objective measurement of walking endurance in 6 minutes.
Routine Assessment of Patient Index Data 3 (RAPID-3)
Subjective questionnaire on performance level of activities of daily living.
Canadian Occupational Performance Measures (COPM)
Subjective report on performance level of activities of daily living and self reported satisfaction level
Center for Epidemiological Studies Depression Scale (CES-D)
self reported questionnaire on frequency of experiencing depression symptoms.
Pain Scale rating (on Routine Assessment of Patient Index Data 3)
Numeric pain rating from 0 to 10 with 0.5 increment
Rheumatoid Arthritis Self-efficacy Scale (RASE)
Self-reported questionnaire rating on self-efficacy in the areas of pain
6 Minute Walk Test (6MWT)
Objective measurement of walking endurance in 6 minutes.
Routine Assessment of Patient Index Data 3 (RAPID-3)
Subjective questionnaire on performance level of activities of daily living.
Canadian Occupational Performance Measures (COPM)
self reported questionnaire on frequency of experiencing depression symptoms.
Center for Epidemiological Studies Depression Scale (CES-D)
self reported questionnaire on frequency of experiencing depression symptoms.

Full Information

First Posted
April 8, 2015
Last Updated
January 9, 2019
Sponsor
University of British Columbia
Collaborators
Mary Pack Research Fund, Vancouver Coastal Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02436785
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 6, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Mary Pack Research Fund, Vancouver Coastal Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid, Spondylarthropathies, Arthritis, Psoriatic, Inflammatory Arthritis
Keywords
music therapy, pain management, self efficacy, patient education, relaxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
open label
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy
Arm Type
Active Comparator
Arm Description
The music therapy group will run for approximately an hour (twice a week) and will involve in-vivo relaxation where the live music is manipulated in terms of speed and intensity to bring on a state of relaxation. 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.
Arm Title
Music Listening
Arm Type
Active Comparator
Arm Description
The control group will also run for approximately an hour (twice a week) and will involve listening to relaxing music on a CD player.
Intervention Type
Other
Intervention Name(s)
Music Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Music Listening
Intervention Description
Listening to relaxing music on a CD player for approximately an hour.
Primary Outcome Measure Information:
Title
Pain Scale rating (on Routine Assessment of Patient Index Data 3)
Description
Numeric pain rating from 0 to 10 with 0.5 increment
Time Frame
after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Secondary Outcome Measure Information:
Title
Rheumatoid Arthritis Self-efficacy Scale (RASE)
Description
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.
Time Frame
after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Title
6 Minute Walk Test (6MWT)
Description
Objective measurement of walking endurance in 6 minutes.
Time Frame
after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Title
Routine Assessment of Patient Index Data 3 (RAPID-3)
Description
Subjective questionnaire on performance level of activities of daily living.
Time Frame
after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Title
Canadian Occupational Performance Measures (COPM)
Description
Subjective report on performance level of activities of daily living and self reported satisfaction level
Time Frame
after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Title
Center for Epidemiological Studies Depression Scale (CES-D)
Description
self reported questionnaire on frequency of experiencing depression symptoms.
Time Frame
after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Title
Pain Scale rating (on Routine Assessment of Patient Index Data 3)
Description
Numeric pain rating from 0 to 10 with 0.5 increment
Time Frame
one month after completion of intervention
Title
Rheumatoid Arthritis Self-efficacy Scale (RASE)
Description
Self-reported questionnaire rating on self-efficacy in the areas of pain
Time Frame
one month after completion of intervention
Title
6 Minute Walk Test (6MWT)
Description
Objective measurement of walking endurance in 6 minutes.
Time Frame
one month after completion of intervention
Title
Routine Assessment of Patient Index Data 3 (RAPID-3)
Description
Subjective questionnaire on performance level of activities of daily living.
Time Frame
one month after completion of intervention
Title
Canadian Occupational Performance Measures (COPM)
Description
self reported questionnaire on frequency of experiencing depression symptoms.
Time Frame
one month after completion of intervention
Title
Center for Epidemiological Studies Depression Scale (CES-D)
Description
self reported questionnaire on frequency of experiencing depression symptoms.
Time Frame
one month after completion of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine M Wright, MA
Organizational Affiliation
G F Strong
Official's Role
Principal Investigator
Facility Information:
Facility Name
G F Strong Rehabilitation Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22258995
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.
Results Reference
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PubMed Identifier
12209485
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.
Results Reference
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PubMed Identifier
16625614
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.
Results Reference
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PubMed Identifier
24575066
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.
Results Reference
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PubMed Identifier
16722953
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.
Results Reference
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PubMed Identifier
16834582
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.
Results Reference
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PubMed Identifier
22001666
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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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. Erratum In: BMC Med Res Methodol. 2023 Mar 11;23(1):59.
Results Reference
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