[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656684":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":30,"studyPopulation":31,"armGroups":32,"interventions":38,"overallOfficials":26,"centralContacts":43,"locations":49,"responsibleParty":65,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":26,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":91,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Marmara University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"20-Item Toronto Alexithymia Scale (TAS-20) Total Score","The TAS-20 is a self-report questionnaire used to assess the severity of alexithymia. It contains 20 items scored on a 5-point Likert scale ranging from 1 to 5. The total score ranges from 20 to 100, where higher scores indicate greater alexithymia severity. Established cut-off scores: ≤51 indicates non-alexithymia, 52 to 60 indicates possible alexithymia, and ≥61 indicates alexithymia.","Baseline (immediately prior to the Ganglion Impar Block procedure)",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Pain Intensity Measured by Visual Analog Scale (VAS)","Pain intensity is evaluated using a standard 10-cm horizontal Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores reflect greater subjective pain severity.",{"measure":18,"description":19,"timeFrame":12},"Hospital Anxiety and Depression Scale (HADS) Scores","The HADS evaluates psychological distress using 14 items categorized into two 7-item subscales: Anxiety (HADS-A) and Depression (HADS-D). Each item is scored from 0 to 3, yielding subscale scores between 0 and 21. Higher scores reflect higher severity of symptoms (cut-off scores: ≥10 for anxiety, ≥7 for depression).",{"measure":21,"description":22,"timeFrame":12},"Health-Related Quality of Life Measured by 12-Item Short Form Survey (SF-12)","A 12-item self-administered generic health questionnaire used to evaluate health-related quality of life across Physical Component Summary (PCS) and Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores reflecting better functional status and quality of life.",{"measure":24,"description":25,"timeFrame":12},"Childhood Trauma Questionnaire (CTQ-33) Total Score","The CTQ-33 is a self-report instrument assessing retrospective childhood traumatic experiences across subscales of emotional, physical, and sexual abuse, emotional and physical neglect, and overprotection\u002Fcontrol. Total scores range from 25 to 150, where higher scores indicate higher severity of childhood trauma.",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"COHORT","CROSS_SECTIONAL","This is a single-center, prospective analytical cross-sectional observational study conducted at Marmara University Pendik Training and Research Hospital, Division of Algology, in collaboration with the Department of Psychiatry.\n\nGanglion Impar Block (GIB) is performed strictly for routine therapeutic indication and standard clinical practice; it is not an experimental intervention designed for this trial. No additional experimental interventions or post-procedural longitudinal follow-up evaluations are administered as part of the research protocol.\n\nFollowing written voluntary informed consent, all study data are collected prospectively at a single pre-procedural time point immediately prior to the injection procedure. Assessment instruments completed by participants (taking approximately 25 to 35 minutes) include:\n\n1. Sociodemographic and Clinical Questionnaire: Age, gender, duration and characteristics of pain, educational level, employment, analgesics, and psychiatric history.\n2. 20-Item Toronto Alexithymia Scale (TAS-20): Assesses total alexithymia severity and its three subdimensions (Difficulty Identifying Feelings, Difficulty Describing Feelings, and Externally Oriented Thinking).\n3. Visual Analog Scale (VAS 0-10 cm): Evaluates subjective baseline pain intensity.\n4. Hospital Anxiety and Depression Scale (HADS): Assesses symptom severity for anxiety (HADS-A) and depression (HADS-D).\n5. 12-Item Short Form Health Survey (SF-12): Evaluates health-related quality of life summary components.\n6. Childhood Trauma Questionnaire (CTQ-33): Assesses retrospective self-reports of childhood maltreatment and neglect.\n\nThe study aims to analyze bivariate correlations among TAS-20 scores, pain intensity, quality of life, and affective symptoms, compare clinical profiles between alexithymic and non-alexithymic cohorts, and determine independent predictors of alexithymia severity using multivariable linear regression models.","Adult patients presenting to Marmara University Pendik Training and Research Hospital, Division of Algology outpatient clinic, who are diagnosed with chronic coccydynia and scheduled for clinically indicated Ganglion Impar Block.",[33],{"label":34,"type":26,"description":35,"interventionNames":36},"Chronic Coccydynia Patients","Adult patients aged 18 years or older diagnosed with chronic coccydynia for at least 3 months, who are scheduled to undergo fluoroscopy-guided Ganglion Impar Block due to persistent pain despite conservative treatments.",[37],"Other: Psychometric and Clinical Survey Battery",[39],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":26},"Psychometric and Clinical Survey Battery","Cross-sectional pre-procedural assessment consisting of self-report questionnaires administered immediately prior to the Ganglion Impar Block procedure. The battery includes the 20-Item Toronto Alexithymia Scale (TAS-20), Visual Analog Scale (VAS 0-10 cm), Hospital Anxiety and Depression Scale (HADS), 12-Item Short Form Health Survey (SF-12), and Childhood Trauma Questionnaire (CTQ-33), alongside a structured sociodemographic data form.",[34],[44],{"name":45,"role":46,"phone":47,"phoneExt":26,"email":48},"OSMAN H GÜNDÜZ, MD, Prof.","CONTACT","+90 216 657 06 06","gunduzh@marmara.edu.tr",[50],{"facility":51,"status":26,"city":52,"state":26,"zip":53,"country":54,"countryCode":26,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Marmara University Pendik Training and Research Hospital","Istanbul","34899","Turkey (Türkiye)",{"type":56,"coordinates":57},"Point",[58,59],28.94966,41.01384,{"lat":59,"lon":58},[62],{"name":63,"role":46,"phone":64,"phoneExt":26,"email":48},"Osman H Gündüz, MD, Prof.","+902166570606",{"type":66,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100656684","alexithymia-pain-intensity-quality-of-life-and-psychological-symptoms-in-chronic-coccydynia-patients-scheduled-for-ganglion-impar-block-100656684",false,"NCT07828145","Alexithymia, Pain Intensity, Quality of Life, and Psychological Symptoms in Chronic Coccydynia Patients Scheduled for Ganglion Impar Block","The Relationship Between Alexithymia Levels and Pain Intensity, Quality of Life, and Psychological Symptoms in Patients Scheduled for Ganglion Impar Block Due to Chronic Coccydynia: A Prospective Analytical Cross-Sectional Study","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Clinical diagnosis of chronic coccydynia persisting for at least 3 months.\n3. Clinical indication and scheduled for Ganglion Impar Block due to persistent pain refractory to conservative treatments.\n4. Literate and possessing sufficient mental capacity to comprehend and complete self-report instruments.\n5. Provision of voluntary written informed consent.\n\nExclusion Criteria:\n\n1. Significant cognitive impairment or communication barriers impairing informed consent capacity or questionnaire completion.\n2. Active psychotic disorder or current manic episode.\n3. Suspected acute self-harm or suicidal risk identified during clinical evaluation.\n4. Chronic coccygeal pain secondary to malignancy, acute fractures, or active infection.\n5. Severe active psychiatric disease currently under medical treatment (e.g., severe mental illness, schizophrenia, bipolar affective disorder).\n\n(Note: Depressive symptoms alone are not an exclusion criterion; they are assessed via HADS and controlled for as covariates in analytical models).","ALL","18 Years",{"count":77,"type":78},70,"ESTIMATED","OBSERVATIONAL","Chronic coccydynia is characterized by pain localized to the coccygeal region that typically worsens with sitting, leading to notable impairments in functional performance and health-related quality of life. In clinical practice, fluoroscopy-guided Ganglion Impar Block (GIB) is commonly performed as an interventional treatment in patients unresponsive to conservative medical therapies.\n\nAlexithymia, defined as a multidimensional personality construct involving difficulty identifying and describing feelings alongside an externally oriented thinking style, has been shown to be prevalent in chronic pain conditions and associated with pain intensity, mood symptoms, and functional disability.\n\nThe primary objective of this prospective analytical cross-sectional study is to examine the relationship between alexithymia levels (evaluated via the 20-item Toronto Alexithymia Scale \\[TAS-20\\]) and pain intensity, health-related quality of life, anxiety, depression, and childhood trauma in patients with chronic coccydynia who are scheduled to undergo Ganglion Impar Block based on routine clinical indications.",[82,83,84],"Coccydynia","Chronic Pain","Alexithymia",[86,82,84,87,88,89,90],"Ganglion Impar Block","TAS-20","Quality of Life","Hospital Anxiety and Depression Scale","Childhood Trauma","NOT_YET_RECRUITING","2026-09-14",{"date":94,"type":95},"2026-09-18","ACTUAL",{"date":97,"type":78},"2026-09",{"date":99,"type":78},"2027-09",{"name":5,"class":6},1]