Alexithymia, Pain Intensity, Quality of Life, and Psychological Symptoms in Chronic Coccydynia Patients Scheduled for Ganglion Impar Block
The Relationship Between Alexithymia Levels and Pain Intensity, Quality of Life, and Psychological Symptoms in Patients Scheduled for Ganglion Impar Block Due to Chronic Coccydynia: A Prospective Analytical Cross-Sectional Study
Chronic coccydynia is characterized by pain localized to the coccygeal region that typically worsens with sitting, leading to notable impairments in functional performance and health-related quality of life. In clinical practice, fluoroscopy-guided Ganglion Impar Block (GIB) is commonly performed as an interventional treatment in patients unresponsive to conservative medical therapies.
Alexithymia, defined as a multidimensional personality construct involving difficulty identifying and describing feelings alongside an externally oriented thinking style, has been shown to be prevalent in chronic pain conditions and associated with pain intensity, mood symptoms, and functional disability.
The primary objective of this prospective analytical cross-sectional study is to examine the relationship between alexithymia levels (evaluated via the 20-item Toronto Alexithymia Scale [TAS-20]) and pain intensity, health-related quality of life, anxiety, depression, and childhood trauma in patients with chronic coccydynia who are scheduled to undergo Ganglion Impar Block based on routine clinical indications.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This is a single-center, prospective analytical cross-sectional observational study conducted at Marmara University Pendik Training and Research Hospital, Division of Algology, in collaboration with the Department of Psychiatry.
Ganglion Impar Block (GIB) is performed strictly for routine therapeutic indication and standard clinical practice; it is not an experimental intervention designed for this trial. No additional experimental interventions or post-procedural longitudinal follow-up evaluations are administered as part of the research protocol.
Following written voluntary informed consent, all study data are collected prospectively at a single pre-procedural time point immediately prior to the injection procedure. Assessment instruments completed by participants (taking approximately 25 to 35 minutes) include:
- Sociodemographic and Clinical Questionnaire: Age, gender, duration and characteristics of pain, educational level, employment, analgesics, and psychiatric history.
- 20-Item Toronto Alexithymia Scale (TAS-20): Assesses total alexithymia severity and its three subdimensions (Difficulty Identifying Feelings, Difficulty Describing Feelings, and Externally Oriented Thinking).
- Visual Analog Scale (VAS 0-10 cm): Evaluates subjective baseline pain intensity.
- Hospital Anxiety and Depression Scale (HADS): Assesses symptom severity for anxiety (HADS-A) and depression (HADS-D).
- 12-Item Short Form Health Survey (SF-12): Evaluates health-related quality of life summary components.
- Childhood Trauma Questionnaire (CTQ-33): Assesses retrospective self-reports of childhood maltreatment and neglect.
The study aims to analyze bivariate correlations among TAS-20 scores, pain intensity, quality of life, and affective symptoms, compare clinical profiles between alexithymic and non-alexithymic cohorts, and determine independent predictors of alexithymia severity using multivariable linear regression models.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: OSMAN H GÜNDÜZ, MD, Prof.
- Номер телефона: +90 216 657 06 06
- Электронная почта: gunduzh@marmara.edu.tr
Места учебы
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Istanbul, Турция (Туркие), 34899
- Marmara University Pendik Training and Research Hospital
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Контакт:
- Osman H Gündüz, MD, Prof.
- Номер телефона: +902166570606
- Электронная почта: gunduzh@marmara.edu.tr
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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:
- Age 18 years or older.
- Clinical diagnosis of chronic coccydynia persisting for at least 3 months.
- Clinical indication and scheduled for Ganglion Impar Block due to persistent pain refractory to conservative treatments.
- Literate and possessing sufficient mental capacity to comprehend and complete self-report instruments.
- Provision of voluntary written informed consent.
Exclusion Criteria:
- Significant cognitive impairment or communication barriers impairing informed consent capacity or questionnaire completion.
- Active psychotic disorder or current manic episode.
- Suspected acute self-harm or suicidal risk identified during clinical evaluation.
- Chronic coccygeal pain secondary to malignancy, acute fractures, or active infection.
- Severe active psychiatric disease currently under medical treatment (e.g., severe mental illness, schizophrenia, bipolar affective disorder).
(Note: Depressive symptoms alone are not an exclusion criterion; they are assessed via HADS and controlled for as covariates in analytical models).
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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Chronic Coccydynia Patients
Adult patients aged 18 years or older diagnosed with chronic coccydynia for at least 3 months, who are scheduled to undergo fluoroscopy-guided Ganglion Impar Block due to persistent pain despite conservative treatments.
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Cross-sectional pre-procedural assessment consisting of self-report questionnaires administered immediately prior to the Ganglion Impar Block procedure.
The battery includes the 20-Item Toronto Alexithymia Scale (TAS-20), Visual Analog Scale (VAS 0-10 cm), Hospital Anxiety and Depression Scale (HADS), 12-Item Short Form Health Survey (SF-12), and Childhood Trauma Questionnaire (CTQ-33), alongside a structured sociodemographic data form.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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20-Item Toronto Alexithymia Scale (TAS-20) Total Score
Временное ограничение: Baseline (immediately prior to the Ganglion Impar Block procedure)
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The TAS-20 is a self-report questionnaire used to assess the severity of alexithymia.
It contains 20 items scored on a 5-point Likert scale ranging from 1 to 5. The total score ranges from 20 to 100, where higher scores indicate greater alexithymia severity.
Established cut-off scores: ≤51 indicates non-alexithymia, 52 to 60 indicates possible alexithymia, and ≥61 indicates alexithymia.
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Baseline (immediately prior to the Ganglion Impar Block procedure)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Pain Intensity Measured by Visual Analog Scale (VAS)
Временное ограничение: Baseline (immediately prior to the Ganglion Impar Block procedure)
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Pain intensity is evaluated using a standard 10-cm horizontal Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores reflect greater subjective pain severity.
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Baseline (immediately prior to the Ganglion Impar Block procedure)
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Hospital Anxiety and Depression Scale (HADS) Scores
Временное ограничение: Baseline (immediately prior to the Ganglion Impar Block procedure)
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The HADS evaluates psychological distress using 14 items categorized into two 7-item subscales: Anxiety (HADS-A) and Depression (HADS-D).
Each item is scored from 0 to 3, yielding subscale scores between 0 and 21.
Higher scores reflect higher severity of symptoms (cut-off scores: ≥10 for anxiety, ≥7 for depression).
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Baseline (immediately prior to the Ganglion Impar Block procedure)
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Health-Related Quality of Life Measured by 12-Item Short Form Survey (SF-12)
Временное ограничение: Baseline (immediately prior to the Ganglion Impar Block procedure)
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A 12-item self-administered generic health questionnaire used to evaluate health-related quality of life across Physical Component Summary (PCS) and Mental Component Summary (MCS).
Scores range from 0 to 100, with higher scores reflecting better functional status and quality of life.
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Baseline (immediately prior to the Ganglion Impar Block procedure)
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Childhood Trauma Questionnaire (CTQ-33) Total Score
Временное ограничение: Baseline (immediately prior to the Ganglion Impar Block procedure)
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The CTQ-33 is a self-report instrument assessing retrospective childhood traumatic experiences across subscales of emotional, physical, and sexual abuse, emotional and physical neglect, and overprotection/control.
Total scores range from 25 to 150, where higher scores indicate higher severity of childhood trauma.
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Baseline (immediately prior to the Ganglion Impar Block procedure)
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
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
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 09.2026.880
Информация о лекарствах и устройствах, исследовательские документы
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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