The Effect of Music Accompanied Aerobic Exercise (Music)

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

Study Overview

• Status: Completed
• Conditions: Fibromyalgia; Exercise; Fibromyalgia (FM); Syndrome Pain
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Control (Standard treatment)

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kartal
    • İstanbul, Kartal, Turkey, 34862
      • İstanbul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: exercise; Do Exercise	Behavioral: Exercise; 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.
Active Comparator: Control; do nothing	Behavioral: Control (Standard treatment); do nothing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 4 weeks

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2023
• Primary Completion (Actual): November 23, 2024
• Study Completion (Actual): December 21, 2024

Study Registration Dates

• First Submitted: April 25, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: exercise; fibromyalgia; syndrome
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Neuromuscular Diseases; Rheumatic Diseases; Disease; Syndrome; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: IstanbulMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No