Arthritis, Rheumatoid Clinical Trial
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?
NCT number | NCT02436785 |
Other study ID # | H14-03446 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 6, 2015 |
Est. completion date | January 31, 2018 |
Verified date | January 2019 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | January 31, 2018 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | G F Strong Rehabilitation Centre | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Mary Pack Research Fund, Vancouver Coastal Health Research Institute |
Canada,
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. — View Citation
Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. Review. Update in: Cochrane Database Syst Rev. 2013;10:CD004843. — View 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. — View 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. — View Citation
Guétin S, Giniès P, Siou DK, Picot MC, Pommié 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. — View 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. — View Citation
Radner H, Ramiro S, Buchbinder R, Landewé 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:CD008951. doi: 10.1002/14651858.CD008951.pub2. Review. — View Citation
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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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Scale rating (on Routine Assessment of Patient Index Data 3) | Numeric pain rating from 0 to 10 with 0.5 increment | after attending 8 Music Therapy or Music Listening sessions over 4 weeks | |
Secondary | 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. | after attending 8 Music Therapy or Music Listening sessions over 4 weeks | |
Secondary | 6 Minute Walk Test (6MWT) | Objective measurement of walking endurance in 6 minutes. | after attending 8 Music Therapy or Music Listening sessions over 4 weeks | |
Secondary | Routine Assessment of Patient Index Data 3 (RAPID-3) | Subjective questionnaire on performance level of activities of daily living. | after attending 8 Music Therapy or Music Listening sessions over 4 weeks | |
Secondary | Canadian Occupational Performance Measures (COPM) | Subjective report on performance level of activities of daily living and self reported satisfaction level | after attending 8 Music Therapy or Music Listening sessions over 4 weeks | |
Secondary | Center for Epidemiological Studies Depression Scale (CES-D) | self reported questionnaire on frequency of experiencing depression symptoms. | after attending 8 Music Therapy or Music Listening sessions over 4 weeks | |
Secondary | Pain Scale rating (on Routine Assessment of Patient Index Data 3) | Numeric pain rating from 0 to 10 with 0.5 increment | one month after completion of intervention | |
Secondary | Rheumatoid Arthritis Self-efficacy Scale (RASE) | Self-reported questionnaire rating on self-efficacy in the areas of pain | one month after completion of intervention | |
Secondary | 6 Minute Walk Test (6MWT) | Objective measurement of walking endurance in 6 minutes. | one month after completion of intervention | |
Secondary | Routine Assessment of Patient Index Data 3 (RAPID-3) | Subjective questionnaire on performance level of activities of daily living. | one month after completion of intervention | |
Secondary | Canadian Occupational Performance Measures (COPM) | self reported questionnaire on frequency of experiencing depression symptoms. | one month after completion of intervention | |
Secondary | Center for Epidemiological Studies Depression Scale (CES-D) | self reported questionnaire on frequency of experiencing depression symptoms. | one month after completion of intervention |
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