跳至主要内容
临床试验/NCT02436785
NCT02436785已完成不适用

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

University of British Columbia2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2015年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Pain Scale rating (on Routine Assessment of Patient Index Data 3)

研究概览

简要总结

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.

详细描述

  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.
  1. Research Method

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

open label

入排标准

年龄范围
16 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Music Therapy (Other)

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.

干预措施: Music Listening (Other)

结局指标

主要结局

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

时间窗: after attending 8 Music Therapy or Music Listening sessions over 4 weeks

Numeric pain rating from 0 to 10 with 0.5 increment

次要结局

  • Routine Assessment of Patient Index Data 3 (RAPID-3)(one month after completion of intervention)
  • Center for Epidemiological Studies Depression Scale (CES-D)(one month after completion of intervention)
  • Rheumatoid Arthritis Self-efficacy Scale (RASE)(one month after completion of intervention)
  • Canadian Occupational Performance Measures (COPM)(one month after completion of intervention)
  • 6 Minute Walk Test (6MWT)(one month after completion of intervention)
  • Pain Scale rating (on Routine Assessment of Patient Index Data 3)(one month after completion of intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine Wright

Principal Investigator

University of British Columbia

研究点 (2)

Loading locations...

相似试验

Do Inflammatory Arthritis Inpatients Receiving Group... | 临床试验