Music Therapy Model "The Bonny Method of Guided Imagery and Music" on Patients With Rheumatoid Arthritis (GIM)
Primary Purpose
Rheumatoid Arthritis, Quality of Life, Chronic Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Music therapy-conversation sessions
Discussion sessions
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, GIM Bonny Method model
Eligibility Criteria
Inclusion Criteria:
- Rheumatoid arthritis (RA)
- Over 18 years of age
Exclusion Criteria:
•None
Sites / Locations
- University Hospital of Larisa, Department of Anesthesiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Μusic therapy-conversation sessions
Discussion sessions
Arm Description
Outcomes
Primary Outcome Measures
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
The SF-36 questionnaire
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
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04380129
Brief Title
Music Therapy Model "The Bonny Method of Guided Imagery and Music" on Patients With Rheumatoid Arthritis
Acronym
GIM
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Thessaly
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Quality of Life, Chronic Pain
Keywords
Rheumatoid Arthritis, GIM Bonny Method model
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Μusic therapy-conversation sessions
Arm Type
Experimental
Arm Title
Discussion sessions
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Music therapy-conversation sessions
Other Intervention Name(s)
GIM Bonny Method
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Discussion sessions
Intervention Description
Discussion sessions without the application of music therapy
Primary Outcome Measure Information:
Title
Impact of the Bonny Method of Guided Imagery and Music (GIM) on relief of chronic pain from rheumatoid arthritis
Description
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
Time Frame
3 years
Title
The SF-36 questionnaire
Description
The SF-36 questionnaire, simultaneous recording of physical and mental health status of patients will be performed.
Time Frame
3 years
Title
The effect of GIM Bonny Method model on the emotional status of careers
Description
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
Time Frame
3 years
Title
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
Description
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.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rheumatoid arthritis (RA)
Over 18 years of age
Exclusion Criteria:
•None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georgia Nika, MSc
Phone
+306945086490
Email
georgia_nika@hotmail.com
Facility Information:
Facility Name
University Hospital of Larisa, Department of Anesthesiology
City
Larissa
State/Province
Thessaly
ZIP/Postal Code
Thessaly
Country
Greece
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eleni Arnaoutoglou, Prof., MD
Phone
+302413502953
Email
earnaout@gmail.com
First Name & Middle Initial & Last Name & Degree
Georgia Nika, MSc
Phone
+306945086490
Email
georgia_nika@hotmail.com
First Name & Middle Initial & Last Name & Degree
Georgia Nika, MSc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Music Therapy Model "The Bonny Method of Guided Imagery and Music" on Patients With Rheumatoid Arthritis
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