NCT07087899

Brief Summary

This randomized controlled study was designed to determine the effects of music on symptom management and quality of life in patients with rheumatoid arthritis. The study was conducted between October 2023 and August 2024 with 88 patients diagnosed with rheumatoid arthritis (41 experimental, 47 control) at the Rheumatology clinic and outpatient clinic of a university hospital in Edirne. Within the scope of this study, the Turkish validity and reliability of the Patient Symptom Thermometer scale were tested. Data were collected using the "Patient Information Form" including sociodemographic and disease-related characteristics, the "EQ-5D General Quality of Life Scale," the "Patient Symptom Thermometer," and the "DAS-28 Disease Activity Score."

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Oct 2023

Shorter than P25 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

Study Start

First participant enrolled

October 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

July 3, 2025

Last Update Submit

July 25, 2025

Conditions

Rheumatoid ArthritisMusicSymptoms Arthritis

Keywords

rheumatoid arthritismusicquality of lifesymptom management

Outcome Measures

Primary Outcomes (2)

  • quality of life score

    Change in the mean scores of the EQ-5D General Quality of Life Scale of the patients at the first interview, on the 15th day and on the 30th day

    one month

  • Patient Symptom Thermometer scores

    Change in mean Patient Symptom Thermometer scores of patients at the first visit, on the 15th day, and on the 30th day

    one month

Study Arms (2)

music

EXPERIMENTAL

The participants were informed about the research process during the first meeting. Participants were told that, if they agreed to participate in the study, they would need to listen to music twice a day-once during the day and once at night-for a period of one month. It was explained that each participant would be provided with a music player and headphones for one month, and that these items would need to be returned after the study ended. Participants were also given information on how to listen to the music. Participants were instructed on how to use the music player, informed that there were two playlists-one for daytime and one for nighttime-and advised to listen to each playlist for a maximum of 30 minutes.

Other: music

control

NO INTERVENTION

In the first interview, participants were informed about the research process. Patient information forms and scales (EQ-5D General Quality of Life Scale, DAS-28 Disease Activity Score and Patient Symptom Thermometer) that would be used in data collection were explained to the participants. Participants were informed about how often and how these forms and scales would be applied. No intervention was applied to the participants in the control group in the study.

Interventions

musicOTHER

listening music

music

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with RA by a physician according to the American College of Rheumatology - The European Alliance of Associations for Rheumatology (ACR-EULAR) 2010 criteria
  • Patients diagnosed with Rheumatoid Arthritis at least 6 months ago
  • Patients with Rheumatoid Arthritis who volunteer to participate in the study

You may not qualify if:

  • Patients with hearing problems
  • Rheumatoid Arthritis patients who do not volunteer to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Yıldız Çilengiroğlu

    Trakya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 28, 2025

Study Start

October 23, 2023

Primary Completion

December 23, 2023

Study Completion

August 25, 2024

Last Updated

July 28, 2025

Record last verified: 2025-07

Locations

TU(1)