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Progressive Muscle Relaxation Exercises on Pain, Kinesiophobia and Functional Status

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive muscle relaxation exercise
Sponsored by
Aksaray University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fibromyalgia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cemile KÜTMEÇ YILMAZRecruiting
  • Aksaray University Health Science FacultyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

To examine the effects of progressive muscle relaxation exercises on pain, kinesiophobia and functional status in fibromyalgia patients.

Control group; routine care and treatment will be applied.

Outcomes

Primary Outcome Measures

Progressive muscle relaxation exercise changes pain
Visual Pain Scale
Progressive muscle relaxation exercise changes kinesiophobia
Tampa Scale for Kinesiophobia
Progressive muscle relaxation exercise changes functional status
Revised Fibromyalgia Impact Questionnaire

Secondary Outcome Measures

Full Information

First Posted
January 5, 2023
Last Updated
January 12, 2023
Sponsor
Aksaray University Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05695274
Brief Title
Progressive Muscle Relaxation Exercises on Pain, Kinesiophobia and Functional Status
Official Title
Effect of Progressive Muscle Relaxation Exercises on Pain, Kinesiophobia and Functional Status in Fibromyalgia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
May 10, 2023 (Anticipated)
Study Completion Date
June 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aksaray University Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
To examine the effects of progressive muscle relaxation exercises on pain, kinesiophobia and functional status in fibromyalgia patients.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group; routine care and treatment will be applied.
Intervention Type
Behavioral
Intervention Name(s)
Progressive muscle relaxation exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progressive muscle relaxation exercise changes pain
Description
Visual Pain Scale
Time Frame
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.
Title
Progressive muscle relaxation exercise changes kinesiophobia
Description
Tampa Scale for Kinesiophobia
Time Frame
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.
Title
Progressive muscle relaxation exercise changes functional status
Description
Revised Fibromyalgia Impact Questionnaire
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CEMİLE KÜTMEÇ YILMAZ, Dr.
Phone
+9003822882784
Email
cemilekutmec@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kadriye SAYIN KASAR, Dr.
Phone
+9003822882785
Email
kadriye_syn_321@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CEMİLE KÜTMEÇ YILMAZ
Organizational Affiliation
Aksaray University, Faculty of Health Science, Nursing Department, Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cemile KÜTMEÇ YILMAZ
City
Merkez
State/Province
Aksaray
ZIP/Postal Code
68100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cemile K YILMAZ
Phone
3822882771
Email
cemilekutmec@yahoo.com
First Name & Middle Initial & Last Name & Degree
Cemile K YILMAZ
Phone
03822882771
Email
cemilekutmec@yahoo.com
Facility Name
Aksaray University Health Science Faculty
City
Aksaray
ZIP/Postal Code
68100
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Progressive Muscle Relaxation Exercises on Pain, Kinesiophobia and Functional Status

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