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- Ensayo clínico NCT07696260
Evaluation of Alexithymia and Its Relationship With Clinical Parameters in Patients With Chronic Coccydynia
Evaluation of the Presence of Alexithymia and Its Relationship With Clinical Parameters in Patients With Chronic Coccydynia (>=3 Months)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Chronic coccydynia is a persistent pain condition localized to the coccygeal region, often exacerbated by sitting and significantly impairing daily activities, functionality, and health-related quality of life. While biomechanical and structural variables play a substantial role in its etiology, the pain can become chronic, making it difficult to explain solely through structural changes. Chronic pain is a complex phenomenon that interacts bidirectionally with cognitive-emotional processes and stress response systems. Within this framework, alexithymia-characterized by difficulty identifying and describing emotions-has been recognized as a psychological trait associated with higher pain intensity and functional interference in chronic pain populations.
The relationship between chronic pain, anxiety, depressive symptoms, and early adverse life events such as childhood trauma is also clinically critical, as these factors can amplify pain perception and restriction of activities. Despite these known associations in general chronic pain conditions, studies comprehensively evaluating alexithymia levels alongside pain duration, mood symptoms, childhood trauma history, and quality of life specifically within the coccydynia population remain limited. This gap in the literature underscores the importance of systematically examining the biopsychosocial components of chronic coccydynia to help optimize multidisciplinary treatment planning.
This prospective, observational cohort study aims to investigate the presence and levels of alexithymia in patients with chronic coccydynia (≥3 months) and to analyze its relationship with clinical and psychological variables. Patients presenting with tailbone pain will be evaluated at the multidisciplinary clinics. Following written informed consent, data collection will be completed in a single session utilizing a comprehensive battery of validated psychometric instruments. These include the Visual Analog Scale (VAS) for pain intensity, the 20-item Toronto Alexithymia Scale (TAS-20), the Hospital Anxiety and Depression Scale (HADS), the 33-item Childhood Trauma Questionnaire (CTQ-33), and the 12-item Short-Form Health Survey (SF-12). The findings are expected to contribute to the early identification of high-risk patient subgroups and strengthen the integration of supportive psychosocial interventions into future chronic pain management protocols.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Reclutamiento
- Marmara University Pendik Training and Research Hospital
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Contacto:
- Osman Hakan Gunduz, Prof. MD
- Número de teléfono: 02166570606
- Correo electrónico: ipek98uyanik@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Being older than 18 years of age
- Volunteering to participate in the study and providing written informed consent
- Being literate and having the mental capacity to comprehend the questionnaires
- Having no active, treated severe psychiatric disorder (such as schizophrenia or bipolar affective disorder)
Exclusion Criteria:
- - Cognitive impairment or communication barriers that compromise the capacity to consent
- Active psychotic disorder or manic episode
- Suspected self-harm or suicide risk during the clinical interview
- Distinct secondary causes of pain such as malignancy, active infection, or acute fracture
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Chronic Coccydynia Patients
Patients aged 18 and older who present to the algology outpatient clinic with a diagnosis of chronic coccydynia lasting for 3 months or longer.
Participants will undergo a single-time biopsychosocial assessment using validated psychometric scales including TAS-20, HADS, CTQ-33, VAS, and SF-12 during their routine evaluation.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Toronto Alexithymia Scale (TAS-20) Score
Periodo de tiempo: Baseline (Single-time assessment during the clinical interview)
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A 20-item self-report questionnaire used to evaluate the presence and severity of alexithymia.
It assesses three subscales: difficulty identifying feelings, difficulty describing feelings, and externally-oriented thinking.
Total scores range from 20 to 100, where higher scores indicate a higher level of alexithymia.
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Baseline (Single-time assessment during the clinical interview)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Visual Analog Scale (VAS) for Pain
Periodo de tiempo: Baseline (Single-time assessment)
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A 10-cm horizontal scale used to measure pain intensity.
Scores range from 0 (no pain) to 10 (worst possible pain).
Participants indicate their current tailbone pain level on this line.
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Baseline (Single-time assessment)
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Hospital Anxiety and Depression Scale (HADS) Score
Periodo de tiempo: Baseline (Single-time assessment)
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A 14-item self-report questionnaire consisting of two subscales: anxiety (7 items) and depression (7 items).
Each subscale is scored from 0 to 21, where higher scores reflect greater severity of anxiety or depression.
Cut-off scores are 10 for anxiety and 7 for depression.
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Baseline (Single-time assessment)
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Childhood Trauma Questionnaire (CTQ-33) Score
Periodo de tiempo: Baseline (Single-time assessment)
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A 33-item scale evaluating retrospective childhood and adolescent adverse experiences.
It assesses emotional abuse, physical abuse, sexual abuse, emotional neglect, physical neglect, and overprotection-control.
Total scores range from 25 to 150, with higher scores representing more severe childhood trauma.
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Baseline (Single-time assessment)
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Short Form Health Survey (SF-12) Score
Periodo de tiempo: Baseline (Single-time assessment)
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A 12-item health-related quality of life survey consisting of 8 domains.
Total and component scores range from 0 to 100, where higher scores indicate better health-related quality of life.
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Baseline (Single-time assessment)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 09.2026.26-0189
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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