FibromyalgiaNCT04823117
The Effect of Music on Quality of Life in Fibromyalgia Patients
An observational study of Fibromyalgia and Music Therapy, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study's aim was to determine the effect of music therapy on symptoms and functions in patients with fibromyalgia syndrome (FMS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibromyalgia, Music Therapy, Quality of Life
- What is being tested?
- music therapy
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2017to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with fibromyalgia, admitted to polyclinics
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Therapeutic Use of Music on Quality of Life in Fibromyalgia Patients: a Randomized Controlled Trial
This study's aim was to determine the effect of music therapy on symptoms and functions in patients with fibromyalgia syndrome (FMS).
Read the detailed description
This study's aim was to determine the effect of music therapy on symptoms and functions in patients with fibromyalgia syndrome (FMS). Women diagnosed with FMS for at least 6 months included in the study. 16 patients were in the music treatment group and 51 patients were in the control group. Patients in music treatment group were given a music CD which includes nature sounds recommended by the Turkish Psychological Association. The patients were evaluated with Fibromyalgia Impact Questionnaire (FIQ) before and after the treatment.
- Conditions
- Fibromyalgia, Music Therapy, Quality of Life
- Being tested
- music therapy
- Keywords
- fibromyalgia, music therapy, fibromyalgia Impact Questionnaire
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyOther
music includes nature sounds recommended by the Turkish Psychological Association
| Study group | Role | What they receive |
|---|---|---|
| Music therapy group | Music therapy lasted 30 minutes every day for a total of 20 days. Receives: Other: music therapy | |
| Control group | No treatment given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire
Changes in Fibromyalgia Impact Questionnaire, the total score is between 0-100. Higher total scores indicate higher disability
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Jun 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagla Ozdemir, Diskapi Teaching and Research Hospital
- Investigators
- Çağla Özdemir, Principal investigator, Dışkapı Eğitim ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823117
- Sponsor's protocol ID
- 34/13
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24575066Alparslan 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.
PubMed 26245724Korhan 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.
PubMed 23375348
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Use of Music on Quality of Life in Fibromyalgia Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04823117
- Acronym / sponsor ID
- 34/13
- Conditions
- Fibromyalgia, Music Therapy, Quality of Life
- Keywords
- fibromyalgia, music therapy, fibromyalgia Impact Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study's aim was to determine the effect of music therapy on symptoms and functions in patients with fibromyalgia syndrome (FMS).
Detailed description
This study's aim was to determine the effect of music therapy on symptoms and functions in patients with fibromyalgia syndrome (FMS). Women diagnosed with FMS for at least 6 months included in the study. 16 patients were in the music treatment group and 51 patients were in the control group. Patients in music treatment group were given a music CD which includes nature sounds recommended by the Turkish Psychological Association. The patients were evaluated with Fibromyalgia Impact Questionnaire (FIQ) before and after the treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music therapy group | – | Other: music therapyMusic therapy lasted 30 minutes every day for a total of 20 days. |
| Control group | – | –No treatment given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with fibromyalgia, admitted to polyclinics
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music therapymusic includes nature sounds recommended by the Turkish Psychological Association | Other | Music therapy group |
Primary outcome
Fibromyalgia Impact Questionnaire
Time frame: 6 months
Changes in Fibromyalgia Impact Questionnaire, the total score is between 0-100. Higher total scores indicate higher disability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Background: PubMed 24575066Garza-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.
- Background: PubMed 26245724Alparslan 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.
- Background: PubMed 23375348Korhan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Çağla Özdemir principal investigator
Dışkapı Eğitim ve Araştırma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Music Therapy, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04823117, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.