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Clinical Trials/NCT04380129
NCT04380129
Completed
N/A

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

University of Thessaly1 site in 1 country74 target enrollmentSeptember 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
University of Thessaly
Enrollment
74
Locations
1
Primary Endpoint
Impact of the Bonny Method of Guided Imagery and Music (GIM) on relief of chronic pain from rheumatoid arthritis
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
February 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elena Arnaoutoglou

Professor of Anesthesiology

University of Thessaly

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 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.

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

Study Sites (1)

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