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

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ClinicalTrials.gov Identifier: NCT04380129
Recruitment Status : Not yet recruiting
First Posted : May 8, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Elena Arnaoutoglou, University of Thessaly

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Quality of Life Chronic Pain Other: Music therapy-conversation sessions Other: Discussion sessions Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Μusic therapy-conversation sessions 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
Other Name: GIM Bonny Method
Active Comparator: Discussion sessions Other: Discussion sessions
Discussion sessions without the application of music therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis (RA)
  • Over 18 years of age

Exclusion Criteria:

•None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04380129


Contacts
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Contact: Georgia Nika, MSc +306945086490 georgia_nika@hotmail.com

Locations
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Greece
University Hospital of Larisa, Department of Anesthesiology
Larissa, Thessaly, Greece, Thessaly
Contact: Eleni Arnaoutoglou, Prof., MD    +302413502953    earnaout@gmail.com   
Contact: Georgia Nika, MSc    +306945086490    georgia_nika@hotmail.com   
Principal Investigator: Georgia Nika, MSc         
Sponsors and Collaborators
University of Thessaly
More Information
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Publications:

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Responsible Party: Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly
ClinicalTrials.gov Identifier: NCT04380129    
Other Study ID Numbers: 24/4ης/11-3-2020
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elena Arnaoutoglou, University of Thessaly:
Rheumatoid Arthritis
GIM Bonny Method model
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Chronic Pain
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations