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Psychological Wellbeing, Physical Activity, and Disability in Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05946356
Recruitment Status : Recruiting
First Posted : July 14, 2023
Last Update Posted : July 14, 2023
Sponsor:
Information provided by (Responsible Party):
Mohamed Magdy ElMeligie, Ahram Canadian University

Study Description
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Brief Summary:
This study aims to investigate the association between psychological wellbeing, physical activity, and disability in patients with fibromyalgia. Participants will complete self-reported questionnaires to assess psychological wellbeing, physical activity, and disability. The study will use descriptive statistics, correlation analysis, and multiple regression analysis to analyze the data.

Condition or disease Intervention/treatment
Fibromyalgia Other: no intervention - cross-sectional observational only

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Relationship Between Psychological Wellbeing, Physical Activity, and Disability in Patients With Fibromyalgia: A Cross-Sectional Study
Estimated Study Start Date : July 15, 2023
Estimated Primary Completion Date : November 25, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Fibromyalgia patients
Participants will complete self-reported questionnaires to assess psychological wellbeing, physical activity, and disability.
 Other: no intervention - cross-sectional observational only
no intervention - cross-sectional observational only


Outcome Measures
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Primary Outcome Measures :
  1. Depression, Anxiety, and Stress Scale (DASS) [ Time Frame: Baseline ]
    epression, Anxiety, and Stress Scale (DASS) is a self-report questionnaire that is used to assess the severity of depression, anxiety, and stress. The DASS consists of 42 items that are scored on a scale of 0 to 3, with 0 indicating "not at all" and 3 indicating "severely." The total score for the DASS is the sum of the scores for the 42 items. A higher score indicates more severe symptoms of depression, anxiety, or stress.

  2. International Physical Activity Questionnaire (IPAQ) [ Time Frame: Baseline ]
    International Physical Activity Questionnaire (IPAQ) is a self-report questionnaire that is used to assess physical activity levels. The IPAQ consists of 7 questions that ask about the frequency, duration, and intensity of physical activity. The IPAQ can be used to assess physical activity levels in people of all ages and activity levels.

  3. Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: Baseline ]
    is a self-report questionnaire that is used to measure disability in patients with fibromyalgia. The FIQ consists of 21 items that ask about the impact of fibromyalgia on physical function, social function, and role function. The FIQ can be used to assess the severity of fibromyalgia and to monitor the effectiveness of treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with fibromyalgia
Criteria

Inclusion Criteria:

  • Diagnosis of fibromyalgia
  • Age between 18 and 70 years old

Exclusion Criteria:

  • Unable to complete self-reported questionnaires
  • Presence of other chronic pain conditions
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05946356


Contacts
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Contact: Mohamed M ElMeligie, Ph.d +201064442032 mohamed.elmeligie@acu.edu.eg

Locations
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Egypt
Outpatient clinic of faculty of physical therapy, Ahram Canadian University Recruiting
Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
Contact: Mohamed M ElMeligie, Ph.d    01064442032    mohamed.elmeligie@acu.edu.eg   
Sponsors and Collaborators
Ahram Canadian University
Investigators
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Study Director: Amal Fawzy, Ph.d Faculty of Physical Therapy, Ahram Canadian University
More Information
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Responsible Party: Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University
ClinicalTrials.gov Identifier: NCT05946356    
Other Study ID Numbers: FIBRO8002023
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases