The Effect of Music Accompanied Aerobic Exercise

NCT ID: NCT06957457

Last Updated: 2025-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-21

Study Completion Date

2024-12-21

Brief Summary

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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

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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

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Fibromyalgia Fibromyalgia (FM) Syndrome Pain Exercise

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental: exercise

Do Exercise

Group Type EXPERIMENTAL

Exercise

Intervention Type 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

do nothing

Group Type ACTIVE_COMPARATOR

Control (Standard treatment)

Intervention Type BEHAVIORAL

do nothing

Interventions

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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.

Intervention Type BEHAVIORAL

Control (Standard treatment)

do nothing

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Berna Dincer

Nursing Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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İstanbul

Istanbul, Kartal, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IstanbulMU

Identifier Type: -

Identifier Source: org_study_id

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