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Assessment of Pain Experience in Fibromyalgia

17 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

70

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Painimation Mobile App
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PainDetect Questionnaire
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 febbraio 2026

Completamento primario (Stimato)

3 aprile 2027

Completamento dello studio (Stimato)

24 giugno 2027

Date di iscrizione allo studio

Primo inviato

17 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 giugno 2026

Primo Inserito (Effettivo)

23 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • Painanimation

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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