Assessment of Pain Experience in Fibromyalgia
Assessment of Pain Experience in Fibromyalgia Using Abstract Animations and Graphic Body Maps, and Determinants of Pain Quality
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Contatti e Sedi
Luoghi di studio
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Şirnak
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Denizli, Şirnak, Turchia (Türkiye)
- Pamukkale University
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
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
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Painimation Mobile App
Lasso di tempo: At baseline (Day 1)
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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.
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At baseline (Day 1)
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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PainDetect Questionnaire
Lasso di tempo: At baseline (Day 1)
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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.
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At baseline (Day 1)
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Central Sensitization Scale
Lasso di tempo: At baseline (Day 1)
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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.
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At baseline (Day 1)
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Pain Catastrophizing Scale
Lasso di tempo: At baseline (Day 1)
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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.
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At baseline (Day 1)
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Brief Pain Inventory
Lasso di tempo: At baseline (Day 1)
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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.
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At baseline (Day 1)
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Fatigue Severity Scale
Lasso di tempo: At baseline (Day 1)
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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.
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At baseline (Day 1)
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The Short Form-12 Health Questionnaire
Lasso di tempo: At baseline (Day 1)
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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.
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At baseline (Day 1)
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Hospital Anxiety and Depression Scale
Lasso di tempo: At baseline (Day 1)
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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.
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At baseline (Day 1)
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Revised Fibromyalgia Impact Questionnaire
Lasso di tempo: At baseline (Day 1)
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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.
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At baseline (Day 1)
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Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
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- Painanimation
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