Rheumatoid ArthritisGIMNCT04380129
Music Therapy Model "The Bonny Method of Guided Imagery and Music" on Patients With Rheumatoid Arthritis
A study testing Music therapy-conversation sessions and Music Listening in people with Rheumatoid Arthritis and Quality of Life, run by University of Thessaly at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Quality of Life, Chronic Pain
- What is being tested?
- Music therapy-conversation sessions and Music Listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2020to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis (RA)
- Over 18 years of age
Who cannot join
- •None
Trial locations and contacts
1 site in 1 country.
Greece1 site
University Hospital of Larissa, Department of Anesthesiology
Larissa, Thessaly, 41110
About this study
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
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.
- Conditions
- Rheumatoid Arthritis, Quality of Life, Chronic Pain
- Being tested
- Music therapy-conversation sessions, Music Listening
- Keywords
- Rheumatoid Arthritis, GIM Bonny Method model
- Medical subject headings
- Arthritis, Rheumatoid, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy-conversation sessionsOther
Also called GIM Bonny Method
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
Music ListeningOther
Music Listening to Helen Bonny's programme.
| Study group | Role | What they receive |
|---|---|---|
| Μusic therapy-conversation sessions | Experimental | Not described Receives: Other: Music therapy-conversation sessions |
| Music listening | Active comparator | Not described Receives: Other: Music Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
The SF-36 questionnaire
The SF-36 questionnaire, simultaneous recording of physical and mental health status of patients will be performed.
Measured: 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
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start1 Sep 2020
- Primary completion15 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380129
- Sponsor's protocol ID
- 24/4ης/11-3-2020
- Acronym
- GIM
- Status last verified
- Mar 2025
- First submitted
- 5 May 2020
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15823498Anagnostopoulos 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.
PubMed 16155784Andrianakos 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.
PubMed 16690763Brazier 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.
PubMed 1285753Coons 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.
PubMed 10747763Cross 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.
PubMed 24550173Dorman 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.
PubMed 10512920Elliott 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.
PubMed 12237208Fishman 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.
PubMed 3300951Gallagher 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.
PubMed 10386115Hays 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.
PubMed 8275167Jenkinson 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.
PubMed 8142947MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950Mathias 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.
PubMed 10688396das 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.
PubMed 10648021
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04380129
- Acronym / sponsor ID
- GIM / 24/4ης/11-3-2020
- Conditions
- Rheumatoid Arthritis, Quality of Life, Chronic Pain
- Keywords
- Rheumatoid Arthritis, GIM Bonny Method model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Μusic therapy-conversation sessions | Experimental | Other: Music therapy-conversation sessions |
| Music listening | Active comparator | Other: Music Listening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Rheumatoid arthritis (RA)
- Over 18 years of age
Key exclusion criteria (1 listed)
- •None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapy-conversation sessionsAlso: GIM Bonny MethodThe 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 | Other | Μusic therapy-conversation sessions |
| Music ListeningMusic Listening to Helen Bonny's programme. | Other | Music listening |
Primary outcome
Impact of the Bonny Method of Guided Imagery and Music (GIM) on relief of chronic pain from rheumatoid arthritis
Time frame: 3 years
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
Time frame: 3 years
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
Time frame: 3 years
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
Time frame: 3 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Background: PubMed 15823498Alamanos Y, Drosos AA. Epidemiology of adult rheumatoid arthritis. Autoimmun Rev. 2005 Mar;4(3):130-6. doi: 10.1016/j.autrev.2004.09.002.
- Background: PubMed 16155784Anagnostopoulos 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.
- Background: PubMed 16690763Andrianakos 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.
- Background: PubMed 1285753Brazier 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.
- Background: PubMed 10747763Coons 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.
- Background: PubMed 24550173Cross 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.
- Background: PubMed 10512920Dorman 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.
- Background: PubMed 12237208Elliott 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.
- Background: PubMed 3300951Fishman 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.
- Background: PubMed 10386115Gallagher 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.
- Background: PubMed 8275167Hays 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.
- Background: PubMed 8142947Jenkinson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy-conversation sessions and Music Listening in people with Rheumatoid Arthritis and Quality of Life, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of the Bonny Method of Guided Imagery and Music (GIM) on relief of chronic pain from rheumatoid arthritis (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04380129, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.