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

Rheumatoid Arthritis Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04380129
• Other study ID #: 24/4??/11-3-2020
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Chronic Pain
• Quality of Life
• Rheumatoid Arthritis

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)

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* Note: There are 29 references in all — Click 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