Clinical trial NCT06957457: The Effect of Music Accompanied Aerobic Exercise
Official title: The Effect of Music Accompanied Aerobic Exercise on Pain, Quality of Life and Well-Being in Patients With Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Fibromyalgia (FM)
Syndrome Pain
Exercise
Keywords: fibromyalgia
syndrome
exercise
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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.).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire Scale
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul
state: Kartal
Study officials:
References: