Psychological Wellbeing, Physical Activity, and Disability in Fibromyalgia

July 7, 2023 updated by: Mohamed Magdy ElMeligie, Ahram Canadian University

The Relationship Between Psychological Wellbeing, Physical Activity, and Disability in Patients With Fibromyalgia: A Cross-Sectional Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Giza
      • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
        • Recruiting
        • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with fibromyalgia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahram Canadian University

Investigators

  • Study Director: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2023

Primary Completion (Estimated)

November 25, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 7, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIBRO8002023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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