NCT04380129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

4.4 years

First QC Date

May 5, 2020

Last Update Submit

March 24, 2025

Conditions

Keywords

Rheumatoid ArthritisGIM Bonny Method model

Outcome Measures

Primary Outcomes (4)

  • 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

  • The SF-36 questionnaire

    The SF-36 questionnaire, simultaneous recording of physical and mental health status of patients will be performed.

    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

    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.

    3 years

Study Arms (2)

Μusic therapy-conversation sessions

EXPERIMENTAL
Other: Music therapy-conversation sessions

Music listening

ACTIVE COMPARATOR
Other: Music Listening

Interventions

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

Also known as: GIM Bonny Method
Μusic therapy-conversation sessions

Music Listening to Helen Bonny's programme.

Music listening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Larissa, Department of Anesthesiology

Larissa, Thessaly, 41110, Greece

Location

Related Publications (29)

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MeSH Terms

Conditions

Arthritis, RheumatoidChronic Pain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 8, 2020

Study Start

September 1, 2020

Primary Completion

January 15, 2025

Study Completion

February 1, 2025

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations