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
1 other identifier
interventional
74
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable rheumatoid-arthritis
Started Sep 2020
Longer than P75 for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 8, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedMarch 28, 2025
March 1, 2025
4.4 years
May 5, 2020
March 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Μusic therapy-conversation sessions
EXPERIMENTALMusic listening
ACTIVE COMPARATORInterventions
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. The musical hearing will include Helen Bonny's program "Caring", 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 * Dvorak - Serenade in E-Dur, Larghetto * Warlock - Capriol Suite, Pieds en I'air
Eligibility Criteria
You may qualify if:
- Rheumatoid arthritis (RA)
- Over 18 years of age
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Larissa, Department of Anesthesiology
Larissa, Thessaly, 41110, Greece
Related Publications (29)
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MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 8, 2020
Study Start
September 1, 2020
Primary Completion
January 15, 2025
Study Completion
February 1, 2025
Last Updated
March 28, 2025
Record last verified: 2025-03