Assessment of Pain Experience in Fibromyalgia

NCT07663604 | Enrolling By Invitation

• 1 other identifier: Painanimation
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fybromyalgia; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• PainDetect Questionnaire

  At baseline (Day 1)

• Central Sensitization Scale

  At baseline (Day 1)

• Pain Catastrophizing Scale

  At baseline (Day 1)

• Brief Pain Inventory

  At baseline (Day 1)

• Fatigue Severity Scale

  At baseline (Day 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zülal TATAR: lead

Study Sites (1)

Pamukkale University

Denizli, Şirnak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): April 3, 2027
• Study Completion (Estimated): June 24, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

TU (1)