NCT04823117

Brief Summary

This study's aim was to determine the effect of music therapy on symptoms and functions in patients with fibromyalgia syndrome (FMS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

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

June 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 25, 2021

Last Update Submit

March 26, 2021

Conditions

Keywords

fibromyalgiamusic therapyfibromyalgia Impact Questionnaire

Outcome Measures

Primary Outcomes (1)

  • Fibromyalgia Impact Questionnaire

    Changes in Fibromyalgia Impact Questionnaire, the total score is between 0-100. Higher total scores indicate higher disability

    6 months

Study Arms (2)

Music therapy group

Music therapy lasted 30 minutes every day for a total of 20 days.

Other: music therapy

Control group

No treatment given.

Interventions

music includes nature sounds recommended by the Turkish Psychological Association

Music therapy group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with fibromyalgia, admitted to polyclinics

You may qualify if:

  • Female patients over the age of 18
  • Being diagnosed as FMS according to 2010 American College of Rheumatology (ACR) criteria for FMS
  • Having the diagnosis of FMS at least six months

You may not qualify if:

  • Patients with hearing problems, pregnancy, another accompanying central sensitization syndrome or schizophrenia
  • Patients with psychiatric illness
  • Patients whose pharmacological treatment for FMS changed within the last three months
  • Patients without a listening device
  • Patients who do not have a cognitive level to answer the questions in the scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çağla Özdemir

Merkez, Kütahya, 43020, Turkey (Türkiye)

Location

Related Publications (3)

  • Garza-Villarreal EA, Wilson AD, Vase L, Brattico E, Barrios FA, Jensen TS, Romero-Romo JI, Vuust P. Music reduces pain and increases functional mobility in fibromyalgia. Front Psychol. 2014 Feb 11;5:90. doi: 10.3389/fpsyg.2014.00090. eCollection 2014.

    PMID: 24575066BACKGROUND
  • Alparslan GB, Babadag B, Ozkaraman A, Yildiz P, Musmul A, Korkmaz C. Effects of music on pain in patients with fibromyalgia. Clin Rheumatol. 2016 May;35(5):1317-21. doi: 10.1007/s10067-015-3046-3. Epub 2015 Aug 6.

    PMID: 26245724BACKGROUND
  • Korhan EA, Uyar M, Eyigor C, Hakverdioglu Yont G, Celik S, Khorshid L. The effects of music therapy on pain in patients with neuropathic pain. Pain Manag Nurs. 2014 Mar;15(1):306-14. doi: 10.1016/j.pmn.2012.10.006. Epub 2013 Jan 31.

    PMID: 23375348BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Çağla Özdemir

    Dışkapı Eğitim ve Araştırma Hastanesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
family medicine specialist

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 30, 2021

Study Start

June 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations