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临床试验/NCT06957457
NCT06957457已完成不适用

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

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年12月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Fibromyalgia Impact Questionnaire Scale

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.).

排除标准

  • •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.

研究组 & 干预措施

Experimental: exercise

Experimental

Do Exercise

干预措施: Exercise (Behavioral)

Control

Active Comparator

do nothing

干预措施: Control (Standard treatment) (Behavioral)

结局指标

主要结局

Fibromyalgia Impact Questionnaire Scale

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Berna Dincer

Nursing Associate Professor

Istanbul Medeniyet University

研究点 (1)

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