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Completed

NCT Number: NCT06957457

The Effect of Music Accompanied Aerobic Exercise

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul

Istanbul, Kartal, 34862, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

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)

Behavioral

do nothing

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

The Effect of Music Accompanied Aerobic Exercise on Pain, Quality of Life and Well-Being in Patients With Fibromyalgia Syndrome

Acronym: Music

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 4, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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