Music Therapy Model The Bonny Method of Guided Imagery and Music on Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis, Quality of Life, Chronic Pain

Intervention / Treatment
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* Other: Music therapy-conversation sessions
* Other: Discussion sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rheumatoid arthritis (RA) Over 18 years of age Exclusion Criteria: •None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Μusic therapy-conversation sessions<br> | Other: Music therapy-conversation sessions<br>* The intervention will be performed four times per patient at a frequency once weekly. An effort shall be made to ensure that each treatment is exactly seven days from the previous one within ± one day. Each session is expected to last approximately seventy minutes (75'). The musical hearing will include Helen Bonny's short program Caring short version, which is proposed by the author of this Music therapy model as the most suitable for patients with chronic and severe pain. The program is as follows: Haydn - Cello Konzert in C, Adagio with duration 9:42 Dvorak - Serenade in E-Dur, Larghetto with duration 6:49 Warlock - Capriol Suite, Pieds en I'air with duration 2:21<br>* Other names: GIM Bonny Method;|
| Active Comparator: Discussion sessions<br> | Other: Discussion sessions<br>* Discussion sessions without the application of music therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the Bonny Method of Guided Imagery and Music (GIM) on relief of chronic pain from rheumatoid arthritis | 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 | 3 years | 
| The SF-36 questionnaire | The SF-36 questionnaire, simultaneous recording of physical and mental health status of patients will be performed. | 3 years | 
| The effect of GIM Bonny Method model on the emotional status of careers | 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 | 3 years | 
| 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 | 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. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, GIM Bonny Method model