Assessment of Pain Experience in Fibromyalgia

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: Enrolling by invitation
• Conditions: Pain; Fybromyalgia

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Şirnak
    • Denizli, Şirnak, Turkey (Türkiye)
      • Pamukkale University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Painimation Mobile App	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

Outcome Measure	Measure Description	Time Frame
PainDetect Questionnaire	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	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	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	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	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	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	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	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

• Sponsor: Zülal TATAR

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Estimated): April 3, 2027
• Study Completion (Estimated): June 24, 2027

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID 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