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NCT Number: NCT07696260

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Osman Hakan Gunduz, Prof. MD

CONTACT

[email protected]

02166570606

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Toronto Alexithymia Scale (TAS-20) Score

    Time frame: 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.

Secondary outcomes

  1. Visual Analog Scale (VAS) for Pain

    Time frame: 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.

  2. Hospital Anxiety and Depression Scale (HADS) Score

    Time frame: 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.

  3. Childhood Trauma Questionnaire (CTQ-33) Score

    Time frame: 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.

  4. Short Form Health Survey (SF-12) Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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