FibromyalgiaMusicNCT06957457
The Effect of Music Accompanied Aerobic Exercise
A study testing Exercise in people with Fibromyalgia and Fibromyalgia (FM), run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study, which was planned as a single-blind randomized controlled design, was to investigate whether aerobic exercise accompanied by music has positive effects on pain, quality of life and well-being in patients with fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Fibromyalgia (FM), Syndrome Pain
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2023to 21 Dec 2024
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria in the Physical Therapy and Rehabilitation unit of the University of Health Sciences Kanuni Sultan Süleyman Training and Research Hospital,
- Being between the ages of 18 and 65,
- Volunteering to participate in the study.
- Having no problem with perception
- Being diagnosed with fibromyalgia at least 6 (six) months ago.
- Not using any alternative treatment method (acupuncture, mud, etc.).
Who cannot join
- Cardiovascular, respiratory, metabolic and rheumatic diseases that may limit exercise;
- Diseases associated with autonomic dysfunction such as arterial hypertension, diabetes and coronary insufficiency;
- Having exercised in the last 3 months,
- Having a disease that causes problems in understanding the questionnaires
- Pregnancy or breastfeeding.
- History of surgery in the last four months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music Accompanied Aerobic Exercise on Pain, Quality of Life and Well-Being in Patients With Fibromyalgia Syndrome
Objective: The aim of this study, which was planned as a single-blind randomized controlled design, was to investigate whether aerobic exercise accompanied by music has positive effects on pain, quality of life and well-being in patients with fibromyalgia syndrome.
Materials and Methods: The study sample consisted of 80 patients diagnosed with fibromyalgia syndrome The patients were randomly assigned to either the experimental (n=40) or control group (n=40) using a computer-based randomization method. Data collection tools included the Personal Information Form , Fibromyalgia Impact Questionnaire Scale , State Anxiety Scale (STAI-I/STAI II) , Psychological Well-Being Scale
Read the detailed description
Objective: The aim of this study, which was planned as a single-blind randomized controlled design, was to investigate whether aerobic exercise accompanied by music has positive effects on pain, quality of life and well-being in patients with fibromyalgia syndrome.
Materials and Methods: The study sample consisted of 80 patients diagnosed with fibromyalgia syndrome The patients were randomly assigned to either the experimental (n=40) or control group (n=40) using a computer-based randomization method. Data collection tools included the Personal Information Form , Fibromyalgia Impact Questionnaire Scale , State Anxiety Scale (STAI-I/STAI II) , Psychological Well-Being Scale
- Conditions
- Fibromyalgia, Fibromyalgia (FM), Syndrome Pain, Exercise
- Being tested
- Exercise, Control (Standard treatment)
- Keywords
- fibromyalgia, syndrome, exercise
- Medical subject headings
- Fibromyalgia, Somatoform Disorders, Motor Activity, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
The exercise program lasts 32 minutes in total. The first 6 (six) minutes of this program consists of warm-up exercises. Active exercise time is 21 (twenty-one) minutes. Relaxation exercises consist of 5 (five) minutes of relaxation exercises. exercise was accompanied by music. it consists of warm-up exercise and relaxation sections.
Control (Standard treatment)Behavioural
do nothing
| Study group | Role | What they receive |
|---|---|---|
| Experimental: exercise | Experimental | Do Exercise Receives: Behavioral: Exercise |
| Control | Active comparator | do nothing Receives: Behavioral: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire Scale
The first item in the questionnaire includes a scale of 0-3 (0: always 1: most of the time 2: sometimes 3: never) for 11 activities of daily living such as shopping, laundry, cooking, making beds, washing dishes by hand, vacuuming carpets, walking a few blocks, visiting friends/relatives, gardening, driving, and climbing stairs. The second and third items ask about well-being and the number of days of problems due to illness. The next seven items assess the patients' ability to work, pain intensity, fatigue, stiffness, good sleep, anxiety and depression during the previous week using VAS. The maximum total score is 100. High scores indicate low functionality of the patient.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start21 Dec 2023
- Primary completion23 Nov 2024
- Study completion21 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Assuming a power of 80% and an α risk of. 05, a sample size of 75 was determined to be appropriate. Considering the possibility of missing data, the study initially included 80 participants in both the experimental and control groups. A computer-based random number generator was used for group assignment, and allocation concealment was ensured by using sealed envelopes containing random numbers opened by a separate researcher. The study was completed with 40 participants in the experimental group and 40 in the control group, due to some participants withdrawing.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Dincer, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957457
- Sponsor's protocol ID
- IstanbulMU
- Acronym
- Music
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Accompanied Aerobic Exercise on Pain, Quality of Life and Well-Being in Patients With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT06957457
- Acronym / sponsor ID
- Music / IstanbulMU
- Conditions
- Fibromyalgia, Fibromyalgia (FM), Syndrome Pain, Exercise
- Keywords
- fibromyalgia, syndrome, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 23 Nov 2024 (actual)
- Study completion
- 21 Dec 2024 (actual)
- First posted
- 4 May 2025 (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.
Objective: The aim of this study, which was planned as a single-blind randomized controlled design, was to investigate whether aerobic exercise accompanied by music has positive effects on pain, quality of life and well-being in patients with fibromyalgia syndrome.
Materials and Methods: The study sample consisted of 80 patients diagnosed with fibromyalgia syndrome The patients were randomly assigned to either the experimental (n=40) or control group (n=40) using a computer-based randomization method. Data collection tools included the Personal Information Form , Fibromyalgia Impact Questionnaire Scale , State Anxiety Scale (STAI-I/STAI II) , Psychological Well-Being Scale
Detailed description
Objective: The aim of this study, which was planned as a single-blind randomized controlled design, was to investigate whether aerobic exercise accompanied by music has positive effects on pain, quality of life and well-being in patients with fibromyalgia syndrome.
Materials and Methods: The study sample consisted of 80 patients diagnosed with fibromyalgia syndrome The patients were randomly assigned to either the experimental (n=40) or control group (n=40) using a computer-based randomization method. Data collection tools included the Personal Information Form , Fibromyalgia Impact Questionnaire Scale , State Anxiety Scale (STAI-I/STAI II) , Psychological Well-Being Scale
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Assuming a power of 80% and an α risk of. 05, a sample size of 75 was determined to be appropriate. Considering the possibility of missing data, the study initially included 80 participants in both the experimental and control groups. A computer-based random number generator was used for group assignment, and allocation concealment was ensured by using sealed envelopes containing random numbers opened by a separate researcher. The study was completed with 40 participants in the experimental group and 40 in the control group, due to some participants withdrawing.
| Arm | Type | Receives |
|---|---|---|
| Experimental: exercise | Experimental | Behavioral: ExerciseDo Exercise |
| Control | Active comparator | Behavioral: Control (Standard treatment)do nothing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being diagnosed with fibromyalgia according to the 2016 American College of Rheumatology criteria in the Physical Therapy and Rehabilitation unit of the University of Health Sciences Kanuni Sultan Süleyman Training and Research Hospital,
- Being between the ages of 18 and 65,
- Volunteering to participate in the study.
- Having no problem with perception
- Being diagnosed with fibromyalgia at least 6 (six) months ago.
Key exclusion criteria (6 listed)
- Cardiovascular, respiratory, metabolic and rheumatic diseases that may limit exercise;
- Diseases associated with autonomic dysfunction such as arterial hypertension, diabetes and coronary insufficiency;
- Having exercised in the last 3 months,
- Having a disease that causes problems in understanding the questionnaires
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| ExerciseThe exercise program lasts 32 minutes in total. The first 6 (six) minutes of this program consists of warm-up exercises. Active exercise time is 21 (twenty-one) minutes. Relaxation exercises consist of 5 (five) minutes of relaxation exercises. exercise was accompanied by music. it consists of warm-up exercise and relaxation sections. | Behavioural | Experimental: exercise |
| Control (Standard treatment)do nothing | Behavioural | Control |
Primary outcome
Fibromyalgia Impact Questionnaire Scale
Time frame: up to 4 weeks
The first item in the questionnaire includes a scale of 0-3 (0: always 1: most of the time 2: sometimes 3: never) for 11 activities of daily living such as shopping, laundry, cooking, making beds, washing dishes by hand, vacuuming carpets, walking a few blocks, visiting friends/relatives, gardening, driving, and climbing stairs. The second and third items ask about well-being and the number of days of problems due to illness. The next seven items assess the patients' ability to work, pain intensity, fatigue, stiffness, good sleep, anxiety and depression during the previous week using VAS. The maximum total score is 100. High scores indicate low functionality of the patient.
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 4 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Fibromyalgia and Fibromyalgia (FM), run by Istanbul Medeniyet University 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 6 inclusion and 6 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 4 May 2025. 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 Scale (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2025.