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Clinical Trials/NCT05835427
NCT05835427CompletedNot Applicable

The Effect of Stretching and Relaxation Exercises on Anxiety in Individuals With Fibromyalgia

Istanbul Medipol University Hospital2 sites in 1 country100 target enrollmentStarted: April 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
2
Primary Endpoint
Fibromyalgia Impact Questionnaire

Study Overview

Brief Summary

Fibromyalgia is a non-articular, chronic rheumatic disease of unknown etiology characterized by widespread musculoskeletal pain, sleep disturbance, fatigue, and the presence of multiple tender points.

Detailed Description

Although the exact etiology cannot be determined in fibromyalgia, it is thought that there are many mechanisms that contribute to the formation of Fibromyalgia. Evidence for some biochemical, neurohormonal, central nervous system, immunological, psychological and environmental factors that may play a role in the disease has been found.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Volunteer
  • Being diagnosed with fibromyalgia

Exclusion Criteria

  • Known neurological disorder
  • Serious orthopedic disorders that will prevent him from exercising
  • Cognitive impairment
  • Using regular NSAIDs
  • Being malnourished and malnourished

Outcomes

Primary Outcomes

Fibromyalgia Impact Questionnaire

Time Frame: 8 weeks

In this scale filled by the patient; Physical function, feeling well, not being able to go to work, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression were measured. With the exception of the well-being trait, low scores indicate recovery or less affliction. Each subheading was asked to be scored between 0-10. Values of 50 points and below were considered as mildly affected, and values above 50 points were considered as severely affected.

Beck Anxiety Scale

Time Frame: 8 weeks

It measures the frequency of anxiety symptoms experienced by the individual. It is a Likert-type self-assessment scale consisting of 21 items and scored between 0-3. The individual is asked to mark only one of the "None", "Mild", "Moderate" and "Severe" options for each item. The total score range is between 0-63. The high score total indicates the high level of anxiety experienced by the individual.

The Pittsburg Sleep Quality Index

Time Frame: 8 weeks

The Pittsburg Sleep Quality Index is a 19-item self-report scale that assesses sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality".

Fibromyalgia ACR Criterion assessed by Composite the Widespread Pain Scale and the Symptom Severity Scale

Time Frame: 8 weeks

It is obtained by adding the Widespread Pain Scale and the Symptom Severity Scale. The maximum total score here is 19+12=31. Accordingly, scores below a total of 12 do not suggest fibromyalgia. Widespread Pain Scale ≥7 and Symptom Severity Scale ≥5.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Istanbul Medipol University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

hazal genc

Principal Investigator

Istanbul Medipol University Hospital

Study Sites (2)

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