Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Evaluation of Alexithymia and Its Relationship With Clinical Parameters in Patients With Chronic Coccydynia

10 de agosto de 2026 actualizado por: Haner Direskeneli, Marmara University

Evaluation of the Presence of Alexithymia and Its Relationship With Clinical Parameters in Patients With Chronic Coccydynia (>=3 Months)

This study aims to investigate the prevalence and levels of alexithymia in patients diagnosed with chronic coccydynia (tailbone pain lasting for 3 months or longer) and to explore its relationship with various clinical and psychological parameters. Chronic coccydynia can significantly impair daily activities, functionality, and reduce quality of life. Participants in this prospective, observational study will be evaluated during their routine visits to the pain management clinic. Evaluation of the participants will be performed using validated self-report questionnaires, including the Toronto Alexithymia Scale (TAS-20) for alexithymia, the Hospital Anxiety and Depression Scale (HADS) for mood symptoms, the Childhood Trauma Questionnaire (CTQ-33) for early life adverse experiences, the Visual Analog Scale (VAS) for pain intensity, and the 12-Item Short Form Health Survey (SF-12) for quality of life. The primary objective of the study is to determine how alexithymia relates to pain severity, duration, emotional symptoms, childhood trauma history, and overall quality of life in this specific population. The results of this pilot study may help strengthen the biopsychosocial approach in the evaluation of chronic coccydynia and optimize future multidisciplinary treatment strategies.

Descripción general del estudio

Estado

Reclutamiento

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

De observación

Inscripción (Estimado)

15

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Istanbul, Turquía (Türkiye)
        • Reclutamiento
        • Marmara University Pendik Training and Research Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Patients aged 18 and older who present to the algology outpatient clinic and meet the diagnostic criteria for chronic coccydynia lasting for 3 months or longer.

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Toronto Alexithymia Scale (TAS-20) Score
Periodo de tiempo: Baseline (Single-time assessment during the clinical interview)
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.
Baseline (Single-time assessment during the clinical interview)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Visual Analog Scale (VAS) for Pain
Periodo de tiempo: Baseline (Single-time assessment)
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.
Baseline (Single-time assessment)
Hospital Anxiety and Depression Scale (HADS) Score
Periodo de tiempo: Baseline (Single-time assessment)
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.
Baseline (Single-time assessment)
Childhood Trauma Questionnaire (CTQ-33) Score
Periodo de tiempo: Baseline (Single-time assessment)
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.
Baseline (Single-time assessment)
Short Form Health Survey (SF-12) Score
Periodo de tiempo: Baseline (Single-time assessment)
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.
Baseline (Single-time assessment)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de marzo de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

6 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de julio de 2026

Publicado por primera vez (Actual)

10 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de agosto de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir