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Recruiting NCT07696260

EVALUATION OF ALEXITHYMIA AND ITS RELATIONSHIP WITH CLINICAL PARAMETERS IN PATIENTS WITH CHRONIC COCCYDYNIA

Observational Chronic Coccydynia Alexithymia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Coccydynia, Alexithymia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

EVALUATION OF THE PRESENCE OF ALEXITHYMIA AND ITS RELATIONSHIP WITH CLINICAL PARAMETERS IN PATIENTS WITH CHRONIC COCCYDYNIA (>=3 MONTHS)

Overview

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 SF-12 Health Survey 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.

Detailed description

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.

Primary outcome measures

  • Toronto Alexithymia Scale (TAS-20) Score [Time frame: Baseline (Single-time assessment during the clinical interview)]
Secondary outcome measures (4)
  • Visual Analog Scale (VAS) for Pain [Time frame: Baseline (Single-time assessment)]
  • Hospital Anxiety and Depression Scale (HADS) Score [Time frame: Baseline (Single-time assessment)]
  • Childhood Trauma Questionnaire (CTQ-33) Score [Time frame: Baseline (Single-time assessment)]
  • Short Form Health Survey (SF-12) Score [Time frame: Baseline (Single-time assessment)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Marmara University Pendik Training and Research Hospital — Istanbul

Identifiers

NCT: NCT07696260 · 09.2026.26-0189

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗