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

10 de agosto de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

15

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Istanbul, Turquia (Türkiye)
        • Recrutamento
        • Marmara University Pendik Training and Research Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Toronto Alexithymia Scale (TAS-20) Score
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Visual Analog Scale (VAS) for Pain
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de março de 2026

Conclusão Primária (Estimado)

1 de março de 2027

Conclusão do estudo (Estimado)

1 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

6 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de julho de 2026

Primeira postagem (Real)

10 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de agosto de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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