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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05695274
Other study ID # 2022/14-05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 10, 2022
Est. completion date November 30, 2023

Study information

Verified date April 2024
Source Aksaray University Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Relaxation techniques are a non-pharmacological therapy option applied to alleviate the symptoms of many different chronic diseases. It has been reported in the literature that PMR is effective on pain, fatigue and stress symptoms in fibromyalgia patients. No study has been found examining the effect of PMR on kinesiophobia and functional status in FM. This study was planned to examine the effect of progressive muscle relaxation exercises on pain, kinesiophobia and functional status in fibromyalgia patients.


Description:

Fibromyalgia (FM), which is a chronic pain disorder, is a difficult disease to treat, and it is stated that a multidisciplinary approach is required in its treatment rather than a single treatment method. Approaches that consider optimal symptom management and functional status in treatment, include non-pharmacological methods in addition to pharmacological treatment, and include psychosocial and behavioral methods are recommended. Non-pharmacological methods that have proven their effectiveness in FM treatment include aerobic exercise, patient education, cognitive therapies, balneotherapy, and physical therapy agents. One of the methods that can be applied in patients with FM is progressive muscle relaxation (PMR) exercises. PMR is an easy, low-cost, and side-effect-free relaxation technique. PMR helps individuals feel calmer and more relaxed through sequential muscle tension and relaxation. It has been reported in the literature that PMR is effective on pain, fatigue and stress symptoms in fibromyalgia patients. No study has been found examining the effect of PMR on kinesiophobia and functional status in FM. Therefore, this study was planned to examine the effect of progressive muscle relaxation exercises on pain, kinesiophobia and functional status in fibromyalgia patients.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date November 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Being older than 18 years of age - Having been diagnosed with fibromiyalgia for at least 6 months ago. - Having no mental disability Exclusion Criteria: - Individuals receiving another complementary and integrative treatment - Individuals who have done progressive muscle relaxation exercise before.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Progressive muscle relaxation exercise
Experimental group Fibromyalgia patients will be provided with progressive relaxation exercises twice a week. Progressive relaxation technique includes stretching and relaxing the bigmuscle groups (hands, arms, neck, shoulders, face, chest, abdomen,hip, feet andfingers) in the human body on purpose. When steps ofProgressive Relaxation Exercises are analyzed, it is observed thatlearning how to take correct and deep breaths is the most impor-tant step towards learning relaxation.

Locations

Country Name City State
Turkey Aksaray University Health Science Faculty Aksaray
Turkey Cemile KÜTMEÇ YILMAZ Merkez Aksaray

Sponsors (1)

Lead Sponsor Collaborator
Aksaray University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progressive muscle relaxation exercise changes pain Visual Pain Scale The pain scores of the patients will be measured before the PMR application and at the end of the PMR application (at the end of the 8th week) two days a week for the 8th week using the visual pain scale. The pain score is min 1 - max 10.
Primary Progressive muscle relaxation exercise changes kinesiophobia Tampa Scale for Kinesiophobia The Kinesiophobia scores of patients will be measured before the PMR application and at the end of the PMR application (at the end of the 8th week) two days a week for the 8th week. A total of 17-68 points are obtained from the scale.
Primary Progressive muscle relaxation exercise changes functional status Revised Fibromyalgia Impact Questionnaire The functional status scores of patients will be measured before the PMR application and at the end of the PMR application (at the end of the 8th week) two days a week for the 8th week. A high score indicates increased disability due to FM.
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