Music Therapy Model "The Bonny Method of Guided Imagery and Music" on Patients With Rheumatoid Arthritis (GIM)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Rheumatoid Arthritis; Chronic Pain
• Intervention / Treatment: Other: Music therapy-conversation sessions; Other: Discussion sessions

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georgia Nika, MSc; Phone Number: +306945086490; Email: georgia_nika@hotmail.com

Study Locations

• Greece
  • Thessaly
    • Larissa, Thessaly, Greece, Thessaly
      • University Hospital of Larisa, Department of Anesthesiology
      • Contact: Georgia Nika, MSc; Phone Number: +306945086490; Email: georgia_nika@hotmail.com
      • Contact: Eleni Arnaoutoglou, Prof., MD; Phone Number: +302413502953; Email: earnaout@gmail.com
      • Principal Investigator: Georgia Nika, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

•None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Μusic therapy-conversation sessions	Other: Music therapy-conversation sessions; 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; Other Names: GIM Bonny Method
ACTIVE_COMPARATOR: Discussion sessions	Other: Discussion sessions; Discussion sessions without the application of music therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Thessaly

Publications and helpful links

General Publications

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• Alamanos Y, Drosos AA. Epidemiology of adult rheumatoid arthritis. Autoimmun Rev. 2005 Mar;4(3):130-6. doi: 10.1016/j.autrev.2004.09.002.
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Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (ACTUAL): May 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; GIM Bonny Method model
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Chronic Pain
• Other Study ID Numbers: 24/4ης/11-3-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No