NCT02436785

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

May 6, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

2.7 years

First QC Date

April 8, 2015

Last Update Submit

January 9, 2019

Conditions

Keywords

music therapypain managementself efficacypatient educationrelaxation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Rheumatoid Arthritis Self-efficacy Scale (RASE)

    after attending 8 Music Therapy or Music Listening sessions over 4 weeks

  • 6 Minute Walk Test (6MWT)

    after attending 8 Music Therapy or Music Listening sessions over 4 weeks

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

    after attending 8 Music Therapy or Music Listening sessions over 4 weeks

  • Canadian Occupational Performance Measures (COPM)

    after attending 8 Music Therapy or Music Listening sessions over 4 weeks

  • Center for Epidemiological Studies Depression Scale (CES-D)

    after attending 8 Music Therapy or Music Listening sessions over 4 weeks

  • +6 more secondary outcomes

Study Arms (2)

Music Therapy

ACTIVE COMPARATOR

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.

Other: Music Therapy

Music Listening

ACTIVE COMPARATOR

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

Other: Music Listening

Interventions

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 Therapy

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

Music Listening

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G F Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Related Publications (9)

  • 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.

    PMID: 22258995BACKGROUND
  • 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.

    PMID: 12209485BACKGROUND
  • 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.

    PMID: 16625614BACKGROUND
  • 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.

    PMID: 24575066BACKGROUND
  • 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.

    PMID: 16722953BACKGROUND
  • 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.

    PMID: 16834582BACKGROUND
  • 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.

    PMID: 22001666BACKGROUND
  • 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.

    PMID: 22066740BACKGROUND
  • 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.

    PMID: 20053272BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylarthropathiesArthritis, PsoriaticArthritisAgnosia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Katherine M Wright, MA

    G F Strong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
open label
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2015

First Posted

May 7, 2015

Study Start

May 6, 2015

Primary Completion

December 31, 2017

Study Completion

January 31, 2018

Last Updated

January 11, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations