FibromyalgiaNCT05946356
Psychological Wellbeing, Physical Activity, and Disability in Fibromyalgia
An observational study of Fibromyalgia, run by Ahram Canadian University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with fibromyalgia
Who may be able to join
- Diagnosis of fibromyalgia
- Age between 18 and 70 years old
Who cannot join
- Unable to complete self-reported questionnaires
- Presence of other chronic pain conditions
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: 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.
- Conditions
- Fibromyalgia
- Being tested
- no intervention - cross-sectional observational only
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention - cross-sectional observational onlyOther
no intervention - cross-sectional observational only
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia patients | Participants will complete self-reported questionnaires to assess psychological wellbeing, physical activity, and disability. Receives: Other: no intervention - cross-sectional observational only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Anxiety, and Stress Scale (DASS)
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.
Measured: Baseline
International Physical Activity Questionnaire (IPAQ)
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.
Measured: Baseline
Fibromyalgia Impact Questionnaire (FIQ)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start15 Jul 2023 (estimated)
- Primary completion25 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study director, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946356
- Sponsor's protocol ID
- FIBRO8002023
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Psychological Wellbeing, Physical Activity, and Disability in Patients With Fibromyalgia: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05946356
- Acronym / sponsor ID
- FIBRO8002023
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 25 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia patients | – | Other: no intervention - cross-sectional observational onlyParticipants will complete self-reported questionnaires to assess psychological wellbeing, physical activity, and disability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with fibromyalgia
Key inclusion criteria (2 listed)
- Diagnosis of fibromyalgia
- Age between 18 and 70 years old
Key exclusion criteria (2 listed)
- Unable to complete self-reported questionnaires
- Presence of other chronic pain conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention - cross-sectional observational onlyno intervention - cross-sectional observational only | Other | Fibromyalgia patients |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Fawzy, Ph.d study director
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, Anxiety, and Stress Scale (DASS) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.