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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 20-Item Toronto Alexithymia Scale (TAS-20) Total Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Psychometric and Clinical Survey Battery (Other)
结局指标
主要结局
20-Item Toronto Alexithymia Scale (TAS-20) Total Score
时间窗: Baseline (immediately prior to the Ganglion Impar Block procedure)
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.
次要结局
- Pain Intensity Measured by Visual Analog Scale (VAS)(Baseline (immediately prior to the Ganglion Impar Block procedure))
- Hospital Anxiety and Depression Scale (HADS) Scores(Baseline (immediately prior to the Ganglion Impar Block procedure))
- Health-Related Quality of Life Measured by 12-Item Short Form Survey (SF-12)(Baseline (immediately prior to the Ganglion Impar Block procedure))
- Childhood Trauma Questionnaire (CTQ-33) Total Score(Baseline (immediately prior to the Ganglion Impar Block procedure))