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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04380129
Other study ID # 24/4??/11-3-2020
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date December 1, 2023

Study information

Verified date May 2020
Source University of Thessaly
Contact Georgia Nika, MSc
Phone +306945086490
Email georgia_nika@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 74
Est. completion date December 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Rheumatoid arthritis (RA)

- Over 18 years of age

Exclusion Criteria:

•None

Study Design


Intervention

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
Discussion sessions
Discussion sessions without the application of music therapy

Locations

Country Name City State
Greece University Hospital of Larisa, Department of Anesthesiology Larissa Thessaly

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (29)

Alamanos Y, Drosos AA. Epidemiology of adult rheumatoid arthritis. Autoimmun Rev. 2005 Mar;4(3):130-6. Review. — View 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. — View 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. Epub 2006 May 11. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Deschamps M, Band PR, Coldman AJ. Assessment of adult cancer pain: shortcomings of current methods. Pain. 1988 Feb;32(2):133-9. Review. — View 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. — View 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. — View 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. — View Citation

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Freynhagen R, Baron R, Gockel U, Tölle 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. — View 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. Review. — View Citation

Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. — View 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. — View Citation

MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. — View 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. — View Citation

Melzack R, Torgerson WS. On the language of pain. Anesthesiology. 1971 Jan;34(1):50-9. — View Citation

Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-99. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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* Note: There are 29 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary The SF-36 questionnaire The SF-36 questionnaire, simultaneous recording of physical and mental health status of patients will be performed. 3 years
Primary 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
Primary 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
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