- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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)
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Места учебы
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Istanbul, Турция (Туркие)
- Рекрутинг
- Marmara University Pendik Training and Research Hospital
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Контакт:
- Osman Hakan Gunduz, Prof. MD
- Номер телефона: 02166570606
- Электронная почта: ipek98uyanik@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Toronto Alexithymia Scale (TAS-20) Score
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Visual Analog Scale (VAS) for Pain
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 09.2026.26-0189
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .