FibromyalgiaNCT05883215
Effects of Social Media Usage on Pain Catastrophizing and Disease Impact in Female Patients With Fibromyalgia Syndrome
An observational study of Fibromyalgia, run by Uskudar State Hospital.
Trial summary
The aim of this study is to investigate the effects of social media usage on pain catastrophizing and disease impact in female individuals diagnosed with fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Pain catastrophizing scale, Beck Anxiety Inventory and Social Media Use Integration Scale
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Dec 2024
- How long will I take part?
- 1 Day
- 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 to 65 years
- Women only
- Adult, Older adult
Study population: Female patients with fibromyalgia syndrome diagnosis who gave consent to participate.
Who may be able to join
- Giving consent.
- Being diagnosed with Fibromyalgia syndrome
- Being female
Who cannot join
- Not giving consent.
- Any disability or illness that may prevent filling out the form or communicating.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to investigate the effects of social media usage on pain catastrophizing and disease impact in female individuals diagnosed with fibromyalgia syndrome.
Read the detailed description
In this study, the total number of female patients obtained as a result of sample size calculations was 73, and the effect of social media use on pain catastrophizing and disease impact of patients diagnosed with fibromyalgia will be investigated. Social media use will be evaluated with the Social Media Use Integration Scale, disease impact with the Fibromyalgia Impact Questionnaire, anxiety levels with the Beck Anxiety Inventory, and pain catastrophizing level with the pain catastrophizing scale. At the same time, a form including demographic data of the patients will be filled. The results will be evaluated with the tests prescribed by the statistical expert, and correlation will be investigated.
- Conditions
- Fibromyalgia
- Being tested
- Pain catastrophizing scale, Beck Anxiety Inventory, Social Media Use Integration Scale, Fibromyalgia Impact Questionnaire
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain catastrophizing scaleOther
The pain catastrophizing scale is a self-report questionnaire used to assess an individual's tendency to engage in catastrophic thinking when experiencing pain. It measures the extent to which a person magnifies, feels helpless, and feels unable to cope with pain. The scale typically consists of several items that ask individuals to rate the degree to which they experience specific thoughts or emotions related to pain catastrophizing, such as "I worry all the time about whether the pain will end" or "I feel like I can't stand it anymore." Participants provide responses on a Likert scale indicating the intensity or frequency of their agreement with each statement. The scale helps researchers and healthcare professionals gain insights into an individual's cognitive and emotional responses to pain, which can have implications for pain management strategies and overall well-being.
Beck Anxiety InventoryOther
Beck Anxiety Inventory" (BAI), which is designed to measure the severity of anxiety symptoms in individuals. The BAI is a self-report questionnaire consisting of 21 items that assess various symptoms of anxiety, such as nervousness, fear, and physiological manifestations of anxiety. Participants rate the intensity of their symptoms over the past week on a scale ranging from 0 (not at all) to 3 (severely). The scores obtained on the BAI can help clinicians and researchers evaluate the presence and severity of anxiety symptoms, monitor changes over time, and guide treatment decisions. It is important to note that the BAI is not a diagnostic tool but rather a measure of self-reported anxiety symptoms.
Social Media Use Integration ScaleOther
The Social Media Use Integration Scale (SMUIS) is a self-report measure that assesses the degree to which individuals integrate social media into their daily lives. It aims to capture the extent to which individuals incorporate social media use into various aspects of their routines, behaviors, and identity. The scale typically consists of items that assess factors such as the frequency and duration of social media use, the importance and impact of social media on personal relationships, the integration of social media into daily activities, and the emotional connection to social media.
Fibromyalgia Impact QuestionnaireOther
The Fibromyalgia Impact Questionnaire (FIQ) is a widely used self-report measure specifically designed to assess the impact of fibromyalgia on various aspects of a person's life. It is a multidimensional questionnaire that evaluates the physical functioning, social functioning, and overall well-being of individuals with fibromyalgia.
The FIQ typically consists of items that ask individuals to rate the impact of fibromyalgia on their ability to perform daily activities, such as work, household chores, and recreational activities. It also assesses the severity of fibromyalgia symptoms, including pain, fatigue, sleep disturbances, and cognitive difficulties. Additionally, the questionnaire may include items related to emotional well-being, social support, and overall quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Female Patients Diagnosed with Fibromyalgia Syndrome | Female patients who give consent to participate and are diagnosed with fibromyalgia syndrome. Receives: Other: Pain catastrophizing scale; Other: Beck Anxiety Inventory; Other: Social Media Use Integration Scale; Other: Fibromyalgia Impact Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between social media use and pain catastrophizing
The possible correlation between the results obtained with the social media integration scale and the results obtained with the pain catastrophizing scale will be investigated with statistical methods.
Measured: 1 day
Correlation between social media use and disease impact
The possible correlation between the results obtained with the social media integration scale and the results obtained with the fibromyalgia impact questionnaire will be investigated with statistical methods.
Measured: 1 day
Correlation between social media use and anxiety
The possible correlation between the results obtained with the social media integration scale and the results obtained with the Beck Anxiety Inventory will be investigated with statistical methods.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 73 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Uskudar State Hospital
- Sponsor type
- Other government
- Collaborators
- Başakşehir Çam & Sakura City Hospital, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Responsible party
- Principal investigator, Mustafa Hüseyin Temel, Uskudar State Hospital
- Investigators
- Mustafa H Temel, M.D., Principal investigator, Uskudar State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883215
- Sponsor's protocol ID
- FMS1
- Status last verified
- May 2023
- First submitted
- 20 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data will be shared upon reasonable request by the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Social Media Usage on Pain Catastrophizing and Disease Impact in Female Patients With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT05883215
- Acronym / sponsor ID
- FMS1
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Uskudar State HospitalOther government
- Collaborators
- Başakşehir Çam & Sakura City Hospital, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 31 May 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.
The aim of this study is to investigate the effects of social media usage on pain catastrophizing and disease impact in female individuals diagnosed with fibromyalgia syndrome.
Detailed description
In this study, the total number of female patients obtained as a result of sample size calculations was 73, and the effect of social media use on pain catastrophizing and disease impact of patients diagnosed with fibromyalgia will be investigated. Social media use will be evaluated with the Social Media Use Integration Scale, disease impact with the Fibromyalgia Impact Questionnaire, anxiety levels with the Beck Anxiety Inventory, and pain catastrophizing level with the pain catastrophizing scale. At the same time, a form including demographic data of the patients will be filled. The results will be evaluated with the tests prescribed by the statistical expert, and correlation will be investigated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female Patients Diagnosed with Fibromyalgia Syndrome | – | Other: Pain catastrophizing scale, Other: Beck Anxiety Inventory, Other: Social Media Use Integration Scale, Other: Fibromyalgia Impact QuestionnaireFemale patients who give consent to participate and are diagnosed with fibromyalgia syndrome. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Female patients with fibromyalgia syndrome diagnosis who gave consent to participate.
Key inclusion criteria (3 listed)
- Giving consent.
- Being diagnosed with Fibromyalgia syndrome
- Being female
Key exclusion criteria (2 listed)
- Not giving consent.
- Any disability or illness that may prevent filling out the form or communicating.
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 |
|---|---|---|
| Pain catastrophizing scaleThe pain catastrophizing scale is a self-report questionnaire used to assess an individual's tendency to engage in catastrophic thinking when experiencing pain. It measures the extent to which a person magnifies, feels helpless, and feels unable to cope with pain. The scale typically consists of several items that ask individuals to rate the degree to which they experience specific thoughts or emotions related to pain catastrophizing, such as "I worry all the time about whether the pain will end" or "I feel like I can't stand it anymore." Participants provide responses on a Likert scale indicating the intensity or frequency of their agreement with each statement. The scale helps researchers and healthcare professionals gain insights into an individual's cognitive and emotional responses to pain, which can have implications for pain management strategies and overall well-being. | Other | Female Patients Diagnosed with Fibromyalgia Syndrome |
| Beck Anxiety InventoryBeck Anxiety Inventory" (BAI), which is designed to measure the severity of anxiety symptoms in individuals. The BAI is a self-report questionnaire consisting of 21 items that assess various symptoms of anxiety, such as nervousness, fear, and physiological manifestations of anxiety. Participants rate the intensity of their symptoms over the past week on a scale ranging from 0 (not at all) to 3 (severely). The scores obtained on the BAI can help clinicians and researchers evaluate the presence and severity of anxiety symptoms, monitor changes over time, and guide treatment decisions. It is important to note that the BAI is not a diagnostic tool but rather a measure of self-reported anxiety symptoms. | Other | Female Patients Diagnosed with Fibromyalgia Syndrome |
| Social Media Use Integration ScaleThe Social Media Use Integration Scale (SMUIS) is a self-report measure that assesses the degree to which individuals integrate social media into their daily lives. It aims to capture the extent to which individuals incorporate social media use into various aspects of their routines, behaviors, and identity. The scale typically consists of items that assess factors such as the frequency and duration of social media use, the importance and impact of social media on personal relationships, the integration of social media into daily activities, and the emotional connection to social media. | Other | Female Patients Diagnosed with Fibromyalgia Syndrome |
| Fibromyalgia Impact QuestionnaireThe Fibromyalgia Impact Questionnaire (FIQ) is a widely used self-report measure specifically designed to assess the impact of fibromyalgia on various aspects of a person's life. It is a multidimensional questionnaire that evaluates the physical functioning, social functioning, and overall well-being of individuals with fibromyalgia. The FIQ typically consists of items that ask individuals to rate the impact of fibromyalgia on their ability to perform daily activities, such as work, household chores, and recreational activities. It also assesses the severity of fibromyalgia symptoms, including pain, fatigue, sleep disturbances, and cognitive difficulties. Additionally, the questionnaire may include items related to emotional well-being, social support, and overall quality of life. | Other | Female Patients Diagnosed with Fibromyalgia Syndrome |
Primary outcome
Correlation between social media use and pain catastrophizing
Time frame: 1 day
The possible correlation between the results obtained with the social media integration scale and the results obtained with the pain catastrophizing scale will be investigated with statistical methods.
Correlation between social media use and disease impact
Time frame: 1 day
The possible correlation between the results obtained with the social media integration scale and the results obtained with the fibromyalgia impact questionnaire will be investigated with statistical methods.
Correlation between social media use and anxiety
Time frame: 1 day
The possible correlation between the results obtained with the social media integration scale and the results obtained with the Beck Anxiety Inventory will be investigated with statistical methods.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Undecided. The individual participant data will be shared upon reasonable request by the corresponding author.
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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.
Mustafa H Temel, M.D. principal investigator
Uskudar State Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Uskudar State Hospital.
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 3 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 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Mustafa H Temel, M.D. (+905342714872, mhuseyintemel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between social media use and pain catastrophizing (time frame: 1 day). 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 31 May 2023.