FibromyalgiaNCT07878286
The Role of Interoceptive Sensitivity in Central Sensitization Symptom Severity in Fibromyalgia
An observational study of Fibromyalgia and Interoception, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia, Interoception, Central Sensitization
- What is being tested?
- Central Sensitization Inventory, The Multidimensional Assessment of Interoceptive Awareness scale-2 and Revised Fibromyalgia Impact Questionnaire
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2026to 15 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Women patients aged 18-65
- Diagnosed with fibromyalgia according to the 2016 ACR criteria
- Experiencing widespread pain for at least 3 months
- Having the cognitive ability to complete the scales
- Having read and signed the informed consent form (ICF)
Who cannot join
- Being under 18 or over 65 years old
- Pregnancy
- Active inflammatory rheumatic disease
- Neurological disease
- Malignancy
- Severe psychiatric disorder
- Serious systemic disease such as heart or kidney failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan Abdülhamid Han Eğitim ve Araştırma Hastanesi
Istanbul
Feyza Nur Yücel, Assoc.Prof., (0216) 542 20 00, dr.fny28@gmail.com
About this study
Official title: Association Between Interoceptive Sensitivity and Central Sensitization Symptom Burden in Women With Fibromyalgia: A Cross-Sectional Study
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.
Read the detailed description
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.
- Conditions
- Fibromyalgia, Interoception, Central Sensitization
- Being tested
- Central Sensitization Inventory, The Multidimensional Assessment of Interoceptive Awareness scale-2, Revised Fibromyalgia Impact Questionnaire, Numeric rating scale, Hospital Anxiety and Depression Scale
- Keywords
- fibromyalgia, interoception, central sensitization
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central Sensitization InventoryOther
Also called CSI
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.
The Multidimensional Assessment of Interoceptive Awareness scale-2Other
Also called MAIA-2
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.
Revised Fibromyalgia Impact QuestionnaireOther
Also called R-FIQ
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.
Numeric rating scaleOther
Also called NRS
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.
Hospital Anxiety and Depression ScaleOther
Also called HADS
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
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia | Women with a diagnosis of fibromyalgia Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (6)
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.).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start9 Sep 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Nur Yucel, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Feyza Nur Yücel, Assoc. Prof., Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878286
- Sponsor's protocol ID
- 30
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scarpina F, Navarra ME, Varallo G, Bernorio R. The role of interoceptive sensibility on central sensitization to pain in vulvodynia. J Sex Med. 2025 Apr 8;22(3):491-499. doi: 10.1093/jsxmed/qdae203.
PubMed 39787715Valenzuela-Moguillansky C, Reyes-Reyes A, Gaete MI. Exteroceptive and Interoceptive Body-Self Awareness in Fibromyalgia Patients. Front Hum Neurosci. 2017 Mar 13;11:117. doi: 10.3389/fnhum.2017.00117. eCollection 2017.
PubMed 28348526Colgan DD, Eddy A, Green K, Oken B. Adaptive body awareness predicts fewer central sensitization-related symptoms and explains relationship between central sensitization-related symptoms and pain intensity: A cross-sectional study among individuals with chronic pain. Pain Pract. 2022 Feb;22(2):222-232. doi: 10.1111/papr.13083. Epub 2021 Nov 11.
PubMed 34651401
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Interoceptive Sensitivity and Central Sensitization Symptom Burden in Women With Fibromyalgia: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07878286
- Acronym / sponsor ID
- 30
- Conditions
- Fibromyalgia, Interoception, Central Sensitization
- Keywords
- fibromyalgia, interoception, central sensitization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 ScaleWomen with a diagnosis of fibromyalgia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Women patients aged 18-65
- Diagnosed with fibromyalgia according to the 2016 ACR criteria
- Experiencing widespread pain for at least 3 months
- Having the cognitive ability to complete the scales
- Having read and signed the informed consent form (ICF)
Key exclusion criteria (7 listed)
- Being under 18 or over 65 years old
- Pregnancy
- Active inflammatory rheumatic disease
- Neurological disease
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central Sensitization InventoryAlso: CSIThe 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. | Other | Fibromyalgia |
| The Multidimensional Assessment of Interoceptive Awareness scale-2Also: MAIA-2The 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. | Other | Fibromyalgia |
| Revised Fibromyalgia Impact QuestionnaireAlso: R-FIQThe 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. | Other | Fibromyalgia |
| Numeric rating scaleAlso: NRSNumeric 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. | Other | Fibromyalgia |
| Hospital Anxiety and Depression ScaleAlso: HADSThis 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 | Other | Fibromyalgia |
Primary outcome
Multidimensional Assessment of Interoceptive Awareness-2, MAIA-2
Time frame: baseline
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.
6 secondary outcomes
Central Sensitization Inventory, CSI
Time frame: Baseline
Revised Fibromyalgia Impact Questionnaire
Time frame: Baseline
HOSPITAL ANXIETY AND DEPRESSION SCALE
Time frame: Baseline
Numeric Pain Rating Scale, NPRS
Time frame: Baseline
Fatigue Severity Scale
Time frame: Baseline
Pittsburgh Sleep Quality Index
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 39787715Scarpina F, Navarra ME, Varallo G, Bernorio R. The role of interoceptive sensibility on central sensitization to pain in vulvodynia. J Sex Med. 2025 Apr 8;22(3):491-499. doi: 10.1093/jsxmed/qdae203.
- Background: PubMed 28348526Valenzuela-Moguillansky C, Reyes-Reyes A, Gaete MI. Exteroceptive and Interoceptive Body-Self Awareness in Fibromyalgia Patients. Front Hum Neurosci. 2017 Mar 13;11:117. doi: 10.3389/fnhum.2017.00117. eCollection 2017.
- Background: PubMed 34651401Colgan DD, Eddy A, Green K, Oken B. Adaptive body awareness predicts fewer central sensitization-related symptoms and explains relationship between central sensitization-related symptoms and pain intensity: A cross-sectional study among individuals with chronic pain. Pain Pract. 2022 Feb;22(2):222-232. doi: 10.1111/papr.13083. Epub 2021 Nov 11.
Related trials for Fibromyalgia
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Active, not recruiting
PEACE: Comparing Chronic Pain Treatment Options
Chronic Pain, Musculoskeletal Pain
Enrolling by invitation
Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation
Arthritis, Fibromyalgia
Active, not recruiting
Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia
Fibromyalgia
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feyza Nur Yücel, Assoc. Prof. study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Interoception, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feyza Nur Yücel, Assoc. Prof. ((0216) 542 20 00 ext. +90, dr.fny28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Assessment of Interoceptive Awareness-2, MAIA-2 (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07878286, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.