An observational study in Fibromyalgia, Interoception and Central Sensitization, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Observational
In fibromyalgia, the increased central sensitization symptom burden can lead to a disruption in the individual's interoception and difficulties in managing symptoms. Additionally, impaired internal perception can also affect conditions such as pain severity, fatigue, sleep quality, and accompanying depression and anxiety in fibromyalgia patients. With this study, the relationship between central sensitization and interoceptive sensitivity in fibromyalgia will be examined, and the relationship of interoceptive sensitivity with issues such as sleep quality, pain severity, fatigue, anxiety, and depression in fibromyalgia patients will also be investigated.
Fibromyalgia is characterized by a complex symptom profile that includes pain, fatigue, sleep disturbances, and psychological distress. Interoception refers to the perception and interpretation of internal bodily signals and may be relevant to how individuals with fibromyalgia experience their symptoms. Examining interoceptive sensitivity alongside central sensitization-related symptoms may help clarify the relationship between internal bodily perception and symptom burden.
This cross-sectional observational study aims to investigate the association between interoceptive sensitivity and central sensitization symptom severity in individuals with fibromyalgia. Additional objectives are to examine the associations of interoceptive sensitivity with pain severity, fatigue, sleep quality, anxiety, and depression. Participants will undergo assessments of these domains using standardized measures, and the relationships between assessment scores will be analyzed.
The study will explore whether differences in interoceptive sensitivity are associated with central sensitization symptom burden and other clinical features of fibromyalgia. The findings may support a more comprehensive understanding of symptom experience in fibromyalgia and provide a basis for future longitudinal and interventional research.
1,369 studies on the registry are indexed under Fibromyalgia; 272 are open to participants now.
This study's planned enrollment of 110 is close to the median of 100 across 282 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 107 studies on the registry; 31 are open to participants now.
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Individuals applying to the Physical Medicine and Rehabilitation Outpatient Clinic of Sultan 2. Abdülhamid Han Training and Research Hospital will be evaluated, and fibromyalgia patients who meet the inclusion criteria and sign the voluntary consent form will be included in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Women with a diagnosis of fibromyalgia
Other: Central Sensitization Inventory · Other: The Multidimensional Assessment of Interoceptive Awareness scale-2 · Other: Revised Fibromyalgia Impact Questionnaire · Other: Numeric rating scale · Other: Hospital Anxiety and Depression Scale
The Central Sensitization Inventory is used by some researchers to investigate pain sensitivity through symptoms associated with central sensitization and related comorbidities. It can help determine the severity of central sensitization. The scale was developed to detect central sensitization in patients with chronic pain and consists of two sections: Section A and Section B. For scoring purposes, only Section A is used. A score of 40 or higher out of 100 is associated with an increased likelihood of central sensitization.
Also known as: CSI
The Multidimensional Assessment of Interoceptive Awareness (MAIA) 2 is a 32-item self-report questionnaire assessing eight dimensions of interoceptive awareness. Items are rated from 0 (never) to 5 (always). Each subscale score is calculated as the mean of its items, with higher scores indicating greater awareness in the corresponding dimension. No total score is calculated.
Also known as: MAIA-2
The Revised Fibromyalgia Impact Questionnaire is composed of 10 items. The first item contains 11 questions related to physical functioning - each question is rated on a 4 point Likert type scale. Items 2 and 3 ask the patient to mark the number of days they felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression. The maximum scale score is 100, with higher scores associated with increasing disability.
Also known as: R-FIQ
Numeric Rating Scale will be used to determine pain intensity during assessments. Participants will be asked to rate their pain intensity by selecting a value between 0 and 10. Higher scores are associated with increased pain severity.
Also known as: NRS
This scale is used to assess anxiety and depression symptoms and consists of 14 items (7 items for anxiety, 7 items for depression). For each subscale, scores range from 0 to 21: • 0-7 points: No symptoms or very mild symptoms • 8-10 points: Moderate symptoms • 11 points or higher
Also known as: HADS
Multidimensional Assessment of Interoceptive Awareness-2, MAIA-2
The participant is required to evaluate "how often each statement generally applies to you in daily life" using a six-point Likert scale with 32 items, where responses range from 0 ("never") to 5 ("always"). The score for each scale is calculated by averaging the scores of its items (ranging from 0 to 5), with higher scores indicating a higher expression of the internal perception components examined by the survey.
Time frame: baseline
Central Sensitization Inventory, CSI
The central sensitization scale is a tool used to assess the hypersensitivity of the central nervous system. This scale includes questions that examine individuals' pain perception and its effects on daily life to detect the effects of central sensitization, which are often seen in chronic pain conditions. The scale evaluates how individuals perceive pain in response to physical contact or other stimuli (pain sensitivity), changes in their sensitivity to hot, cold, or pressure (sensory changes), how the persistence of pain affects their daily activities, and the impact of pain on their emotional state (anxiety, depression, etc.).
Time frame: Baseline
Revised Fibromyalgia Impact Questionnaire
It will be used to evaluate the disease impact and symptom severity related to fibromyalgia in participants. It is a scale that evaluates the functional status, overall disease impact, and symptom severity in fibromyalgia patients over the past 7 days. As the total score obtained increases, it is accepted that the disease impact associated with fibromyalgia also increases.
Time frame: Baseline
HOSPITAL ANXIETY AND DEPRESSION SCALE
It is a 14-item self-report scale that quickly, reliably, and independently of medical conditions assesses patients' anxiety and depression symptoms over the past week.
Time frame: Baseline
Numeric Pain Rating Scale, NPRS
Pain severity will be evaluated using a scale ranging from 0 (no pain) to 10 (unbearable pain). Participants will be asked to rate their average pain levels over the past week.
Time frame: Baseline
Fatigue Severity Scale
It will be used to assess the participants' level of fatigue. The scale is a 9-item measure that evaluates the impact of fatigue on daily life activities, physical function, motivation, and social life. The items are scored on a scale of 1-7, with higher scores indicating greater fatigue severity.
Time frame: Baseline
Pittsburgh Sleep Quality Index
It will be used to evaluate the sleep quality of the participants. It is a scale that evaluates sleep quality and sleep disorders within the last month. The scale consists of seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Time frame: Baseline
Started Sep 2026 (actual). Primary completion is estimated for Jan 2027, 4 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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