search
Back to results

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
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, GIM Bonny Method model

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 5, 2020
Last Updated
May 7, 2020
Sponsor
University of Thessaly
search

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
Citations:
PubMed Identifier
15823498
Citation
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.
Results Reference
background
PubMed Identifier
16155784
Citation
Anagnostopoulos F, Niakas D, Pappa E. Construct validation of the Greek SF-36 Health Survey. Qual Life Res. 2005 Oct;14(8):1959-65. doi: 10.1007/s11136-005-3866-8.
Results Reference
background
PubMed Identifier
16690763
Citation
Andrianakos A, Trontzas P, Christoyannis F, Kaskani E, Nikolia Z, Tavaniotou E, Georgountzos A, Krachtis P; ESORDIG Study Group. Prevalence and management of rheumatoid arthritis in the general population of Greece--the ESORDIG study. Rheumatology (Oxford). 2006 Dec;45(12):1549-54. doi: 10.1093/rheumatology/kel140. Epub 2006 May 11.
Results Reference
background
PubMed Identifier
1285753
Citation
Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.
Results Reference
background
PubMed Identifier
10747763
Citation
Coons SJ, Rao S, Keininger DL, Hays RD. A comparative review of generic quality-of-life instruments. Pharmacoeconomics. 2000 Jan;17(1):13-35. doi: 10.2165/00019053-200017010-00002.
Results Reference
background
PubMed Identifier
24550173
Citation
Cross M, Smith E, Hoy D, Carmona L, Wolfe F, Vos T, Williams B, Gabriel S, Lassere M, Johns N, Buchbinder R, Woolf A, March L. The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1316-22. doi: 10.1136/annrheumdis-2013-204627. Epub 2014 Feb 18.
Results Reference
background
PubMed Identifier
10512920
Citation
Dorman PJ, Dennis M, Sandercock P. How do scores on the EuroQol relate to scores on the SF-36 after stroke? Stroke. 1999 Oct;30(10):2146-51. doi: 10.1161/01.str.30.10.2146.
Results Reference
background
PubMed Identifier
12237208
Citation
Elliott AM, Smith BH, Hannaford PC, Smith WC, Chambers WA. The course of chronic pain in the community: results of a 4-year follow-up study. Pain. 2002 Sep;99(1-2):299-307. doi: 10.1016/s0304-3959(02)00138-0.
Results Reference
background
PubMed Identifier
3300951
Citation
Fishman B, Pasternak S, Wallenstein SL, Houde RW, Holland JC, Foley KM. The Memorial Pain Assessment Card. A valid instrument for the evaluation of cancer pain. Cancer. 1987 Sep 1;60(5):1151-8. doi: 10.1002/1097-0142(19870901)60:53.0.co;2-g.
Results Reference
background
PubMed Identifier
10386115
Citation
Gallagher RM. Primary care and pain medicine. A community solution to the public health problem of chronic pain. Med Clin North Am. 1999 May;83(3):555-83, v. doi: 10.1016/s0025-7125(05)70124-3.
Results Reference
background
PubMed Identifier
8275167
Citation
Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.
Results Reference
background
PubMed Identifier
8142947
Citation
Jenkinson C, Wright L, Coulter A. Criterion validity and reliability of the SF-36 in a population sample. Qual Life Res. 1994 Feb;3(1):7-12. doi: 10.1007/BF00647843.
Results Reference
background
PubMed Identifier
14258950
Citation
MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
Results Reference
background
PubMed Identifier
10688396
Citation
Mathias SD, Colwell HH, Miller DP, Moreland LW, Buatti M, Wanke L. Health-related quality of life and functional status of patients with rheumatoid arthritis randomly assigned to receive etanercept or placebo. Clin Ther. 2000 Jan;22(1):128-39. doi: 10.1016/s0149-2918(00)87984-9.
Results Reference
background
PubMed Identifier
10648021
Citation
das Chagas Medeiros MM, Ferraz MB, Quaresma MR. The effect of rheumatoid arthritis on the quality of life of primary caregivers. J Rheumatol. 2000 Jan;27(1):76-83.
Results Reference
background
PubMed Identifier
1235985
Citation
Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5.
Results Reference
background
PubMed Identifier
12687514
Citation
Minnock P, Fitzgerald O, Bresnihan B. Quality of life, social support, and knowledge of disease in women with rheumatoid arthritis. Arthritis Rheum. 2003 Apr 15;49(2):221-7. doi: 10.1002/art.11001.
Results Reference
background
PubMed Identifier
16047519
Citation
Pappa E, Kontodimopoulos N, Niakas D. Validating and norming of the Greek SF-36 Health Survey. Qual Life Res. 2005 Jun;14(5):1433-8. doi: 10.1007/s11136-004-6014-y.
Results Reference
background
PubMed Identifier
11508587
Citation
Sokoll KB, Helliwell PS. Comparison of disability and quality of life in rheumatoid and psoriatic arthritis. J Rheumatol. 2001 Aug;28(8):1842-6.
Results Reference
background
PubMed Identifier
11297029
Citation
Stavem K, Lossius MI, Kvien TK, Guldvog B. The health-related quality of life of patients with epilepsy compared with angina pectoris, rheumatoid arthritis, asthma and chronic obstructive pulmonary disease. Qual Life Res. 2000;9(7):865-71. doi: 10.1023/a:1008993821253.
Results Reference
background
PubMed Identifier
8055200
Citation
Symmons DP, Barrett EM, Bankhead CR, Scott DG, Silman AJ. The incidence of rheumatoid arthritis in the United Kingdom: results from the Norfolk Arthritis Register. Br J Rheumatol. 1994 Aug;33(8):735-9. doi: 10.1093/rheumatology/33.8.735.
Results Reference
background
PubMed Identifier
19333951
Citation
van der Woude D, Houwing-Duistermaat JJ, Toes RE, Huizinga TW, Thomson W, Worthington J, van der Helm-van Mil AH, de Vries RR. Quantitative heritability of anti-citrullinated protein antibody-positive and anti-citrullinated protein antibody-negative rheumatoid arthritis. Arthritis Rheum. 2009 Apr;60(4):916-23. doi: 10.1002/art.24385.
Results Reference
background
PubMed Identifier
16103423
Citation
Wild CP. Complementing the genome with an "exposome": the outstanding challenge of environmental exposure measurement in molecular epidemiology. Cancer Epidemiol Biomarkers Prev. 2005 Aug;14(8):1847-50. doi: 10.1158/1055-9965.EPI-05-0456. No abstract available.
Results Reference
background
PubMed Identifier
2621341
Citation
Thompson C. The nursing assessment of the patient with cardiac pain on the coronary care unit. Intensive Care Nurs. 1989 Dec;5(4):147-54. doi: 10.1016/0266-612x(89)90002-3.
Results Reference
background
PubMed Identifier
1593914
Citation
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Results Reference
background
PubMed Identifier
4924784
Citation
Melzack R, Torgerson WS. On the language of pain. Anesthesiology. 1971 Jan;34(1):50-9. doi: 10.1097/00000542-197101000-00017. No abstract available.
Results Reference
background
PubMed Identifier
17022849
Citation
Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006 Oct;22(10):1911-20. doi: 10.1185/030079906X132488.
Results Reference
background
PubMed Identifier
11920397
Citation
Doran MF, Pond GR, Crowson CS, O'Fallon WM, Gabriel SE. Trends in incidence and mortality in rheumatoid arthritis in Rochester, Minnesota, over a forty-year period. Arthritis Rheum. 2002 Mar;46(3):625-31. doi: 10.1002/art.509.
Results Reference
background
PubMed Identifier
3283659
Citation
Deschamps M, Band PR, Coldman AJ. Assessment of adult cancer pain: shortcomings of current methods. Pain. 1988 Feb;32(2):133-139. doi: 10.1016/0304-3959(88)90061-9.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs