Assessment of Pain Experience in Fibromyalgia

June 17, 2026 updated by: Zülal TATAR

Assessment of Pain Experience in Fibromyalgia Using Abstract Animations and Graphic Body Maps, and Determinants of Pain Quality

The aim of this study is to assess pain in individuals with fibromyalgia using abstract animations and graphical body maps, and to investigate the determinants of pain quality.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

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

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study will be conducted on individuals followed by the Rheumatology Department of Pamukkale University Faculty of Medicine and diagnosed with Fibromyalgia according to the 2016 ACR Fibromyalgia Syndrome diagnostic criteria.

Description

Inclusion Criteria:

  • Being 18 years of age or older
  • Being female
  • Having a diagnosis of fibromyalgia syndrome according to the American Rheumatology Association Criteria
  • Not receiving active physiotherapy and rehabilitation treatment
  • Volunteering to participate in the study.

Exclusion Criteria:

  • Having a serious pathology or disease that could compromise the assessment process or affect clinical decision-making (metastasis, cancer, untreated or unhealed fractures, central nervous system disease or history of diabetes, pain outside the musculoskeletal system)
  • Having severe mental and psychological disorders

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Painimation Mobile App
Time Frame: At baseline (Day 1)
An electronic pain assessment tool designed to measure the location, nature, and intensity of pain using "pain animations and graphical images." Patients use a colorable body image to indicate the areas affected by pain. They then select from eight animations that represent their pain experiences. The size, speed, and intensity of these animations can be adjusted to accurately represent pain severity. Painimation animations are derived from the McGill Pain Questionnaire Short Form. They were developed through a human-centered design process involving patients with acute and chronic pain, clinicians, researchers, and design students. The animations correspond to the following pain qualities: "pounding," "shooting," "throbbing," "tingling," "cramping," "burning," "stabbing," and "electrifying." The area of the body affected by pain will be calculated based on the proportion of selected pixels.
At baseline (Day 1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PainDetect Questionnaire
Time Frame: At baseline (Day 1)
The PainDetect Questionnaire is a simple, self-administered, and convenient screening questionnaire that allows for the identification of neuropathic pain components in patients with chronic pain. It consists of four main sections. The total score is calculated by summing the scores from the last three sections and ranges from -1 to 38. Scores of 12 and below indicate that the neuropathic pain component is unlikely, while scores of 19 and above indicate a high probability of the neuropathic pain component being present. Scores between 12 and 19 are considered inconclusive.
At baseline (Day 1)
Central Sensitization Scale
Time Frame: At baseline (Day 1)
The Central Sensitization Scale consists of two sections. Section A comprises 25 items that assess symptoms related to physical and emotional health commonly seen in disorders associated with central sensitization. Each item is scored on a 5-point Likert scale ranging from (0) "never" to (4) "always," with a total score of 100. Higher scores indicate a higher level of symptom presence. Section B includes 7 diagnoses assessed within the scope of central sensitization syndrome (tension-type headache or migraine, fibromyalgia, irritable bowel syndrome, restless legs syndrome, temporomandibular joint disorder, chronic fatigue syndrome, and multiple chemical sensitivities) and three additional diagnoses reported to be associated with central sensitization (depression, anxiety or panic attacks, and neck injury). Participants are asked the following question: "Have you been diagnosed by a doctor with any of the following conditions?" and the year of diagnosis is indicated.
At baseline (Day 1)
Pain Catastrophizing Scale
Time Frame: At baseline (Day 1)
The Pain Catastrophizing Scale is a scale used to assess the psychological aspects of pain-related symptoms in three dimensions: rumination, helplessness, and amplification. The scale includes 13 items related to specific emotions and thoughts defined as negative associations. Five of these items relate to rumination, six to helplessness, and two to amplification. Patients are asked how frequently they recall each thought in these items. Each item is scored between 0-4, and the total score is calculated between 0-52.
At baseline (Day 1)
Brief Pain Inventory
Time Frame: At baseline (Day 1)
The Brief Pain Inventory is a short, easy-to-administer assessment method that can be used to evaluate pain. It consists of two sections: pain intensity and impairment caused by pain. It has 4 items related to pain intensity and 7 items related to impairment caused by pain. Each item is rated on a scale of 0 to 10. The total score for both sections is calculated by summing the scores given to each item and dividing the sum by the number of questions, and ranges from 0 to 10. Higher scores indicate more pain and greater impairment caused by pain.
At baseline (Day 1)
Fatigue Severity Scale
Time Frame: At baseline (Day 1)
Published by Krupp in 1989, the FSS consists of nine items. For each item, the patient is asked to choose a number between 1 and 7 indicating how much they agree with the statement; 1 means strongly disagree, and 7 means strongly agree. Generally, scores of 4 and above indicate severe fatigue.
At baseline (Day 1)
The Short Form-12 Health Questionnaire
Time Frame: At baseline (Day 1)
A summary version of the Short Form-36 Health Questionnaire, the SF-12 can also be divided into physical and mental sections and consists of a total of 12 questions. The physical component of the scale is scored between 24 and 56 points, while the mental component is scored between 19 and 60 points. Higher scores on the scale indicate a higher quality of life.
At baseline (Day 1)
Hospital Anxiety and Depression Scale
Time Frame: At baseline (Day 1)
The Hospital Anxiety and Depression Scale is a 14-item, two-factor scale that assesses patients' anxiety and depression levels. Seven of these items assess anxiety, and the other seven assess depression. Each item is scored on a four-point scale. The total score for anxiety and depression ranges from 0 to 21. Scores between 0 and 7 indicate a normal emotional state. Scores above 7 on either the anxiety or depression subscales have been reported to indicate the presence of anxiety and depressive disorders.
At baseline (Day 1)
Revised Fibromyalgia Impact Questionnaire
Time Frame: At baseline (Day 1)
The Revised Fibromyalgia Impact Questionnaire is a questionnaire evaluating limitations and functional disability in patients with fibromyalgia. It consists of 21 questions divided into three sections: function, general, and symptoms. All questions are rated on a numerical scale from 0 to 10. A score of 70 or higher indicates severe disability in this patient group. Higher scores indicate greater fibromyalgia-related disability.
At baseline (Day 1)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zülal TATAR

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Painanimation

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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