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临床试验/NCT04380129
NCT04380129已完成不适用

A Randomized Clinical Trial Investigating the Effect of the Music Therapy Model "The Bonny Method of Guided Imagery and Music (GIM)" on Patients Suffering from Rheumatoid Arthritis with Chronic Pain

University of Thessaly2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
2
主要终点
Impact of the Bonny Method of Guided Imagery and Music (GIM) on relief of chronic pain from rheumatoid arthritis

研究概览

简要总结

The aim of this study is to investigate the effect of music therapy and in particular of the model "The Bonny Method of Guided Imagery and Music (GIM)" in patients with rheumatoid arthritis (RA) in relation to both chronic pain relief and other psychosocial parameters, as well as the effect of the method on caregiver burden.

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Rheumatoid arthritis (RA)
  • Over 18 years of age

排除标准

  • 未提供

结局指标

主要结局

Impact of the Bonny Method of Guided Imagery and Music (GIM) on relief of chronic pain from rheumatoid arthritis

时间窗: 3 years

The Wong-Baker Face Scale will be used to assess the pain with a simultaneous visual, numeric and functional analog display of the pain the patient is experiencing at the time of the interview. The scale depicts a series of six (6) face faces. The 6 faces are given the following marks: * 0 no pain * 2 slight pain not affecting certain activities * 4 slight pain affecting certain activities * 6 moderate pain that does not affect certain activities (such as telephone, TV, reading etc) * 8 severe pain affecting certain activities (such as telephone, TV, reading etc) * 10 intolerable pain that does not even allow for simple voice communication

The effect of GIM Bonny Method model on the careers and their relationship with patients both during the intervention period and three months after the first interview

时间窗: 3 years

The Zarit Burden Interview (ZBI) questionnaire was created to measure the burden on careers. It consists of 22 questions. The scale score varies from 0-88 and the smaller the score, the smaller the charge.

The SF-36 questionnaire

时间窗: 3 years

The SF-36 questionnaire, simultaneous recording of physical and mental health status of patients will be performed.

The effect of GIM Bonny Method model on the emotional status of careers

时间窗: 3 years

The Barthel scale has been used worldwide since it was created in 1965. It is a balanced instrument for scoring basic mobility, self-care and restraint activities, and has 10 thematic areas. The overall score varies from 0 to 100, indicating full dependency and full autonomy, respectively. To be considered autonomous, the patient should not seek human assistance in any of the activities rated. Scale of self-service assessment - Barthel scale

次要结局

未报告次要终点

研究者

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

Elena Arnaoutoglou

Professor of Anesthesiology

University of Thessaly

研究点 (2)

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