Situation and Characteristics of Pain in Patients With Congenital Coagulopathies in Spain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Perception of joint pain
研究概览
简要总结
Introduction. The development of joint hemorrhages in patients with congenital coagulopathies favor the development of an intra-articular, degenerative and progressive lesion (hemophilic arthropathy). Pain is one of the main clinical manifestations of hemophilic arthropathy and is related to the development of disability and a worse quality of life.
Objective. Observe the characteristics of pain, coping models and the perception of quality of life in patients with congenital coagulopathies.
Study design. Observational, cross-sectional and multi-center study. Method. 80 patients with congenital coagulopathies (hemophilia A and B, and von Willebrand's disease), of legal age, will be included in the study. Patients will be recruited in six centers, from different regions of Spain. The study variables and measurement instruments used will be: pain perception (numerical pain scale, Tampa Scale of kinesiophobia and Pain Catastrophizing Scale); perception of quality of life (Short Form -36 questionnaires); anxiety (State-Trait Anxiety Questionnaire); coping strategies (Coping Strategy Questionnaire); and disease perception (Illness behaviour questionnaire and Revised Illness Perception Questionnaire). A descriptive statistical analysis of the dependent and independent variables will be carried out. In the same way, the correlations between the variables and the characteristics of the subjects will be analyzed according to age, the type of coagulopathy and the degree of sequelae.
Expected results. Observe the characteristics of pain, its coping models and its implication in the quality of life in patients with congenital coagulopathies, and evaluate the independent variables related to the perception of pain.
详细描述
Objectives:
Main objective: to observe the characteristics of pain, its coping models and its implication in the quality of life in patients with congenital coagulopathies. Secondary objectives: to evaluate the degree of kinesiofobia and catastrophism in patients with congenital coagulopathies; analyze the perception of quality of life, of disease and of anxiety in patients with hemophilia and von Willebrand's disease of age; and to identify the ingestion and administration of analgesic drugs in patients with hemophilia or von Willebrand's disease for the control of pain.
Design of the investigation Describe the type of study, methodology, research variables Cross-sectional and multicentric observational study, carried out in patients with congenital coagulopathies, with the aim of knowing the characteristics of pain, its coping strategies and its implications for quality of life.
Collection of information Instruments and data collection process
- Numerical scale of pain. The patient assigns pain a numerical value between 0 and 10. With this scale pain is considered a simple one-dimensional concept and is measured only according to its intensity. The scale is discrete, not continuous.
- Short Form 36 Health Survey (SF-36). Health questionnaire that measures the quality of life related to health. Generic instrument consisting of 36 questions, covering 8 dimensions (physical functioning, physical role, body pain, general health, vitality, social functioning, emotional role and mental health of the patient).
- State-Trait Anxiety Inventory (STAI). Generic instrument that assesses the current level of anxiety and the predisposition of the person to respond to stress. It consists of two sections that let you know how you feel at a certain time and how you feel in general. The score for each scale can range from 0-30, indicating higher scores, higher levels of anxiety.
- Tampa Scale of kinesiophobia (TSK-11SV). Through this scale the fear of movement of the patients included in the study will be evaluated. This self-report measure contains 17 items on fear of movement and recurrence of a new lesion. Four of the items have a negative wording and carry an inverse notation. The scores of the different items evaluated are added to give a total score, where the highest values reflect a greater fear of injury or relapse of the same.
- Pain catastrophizing scale (PCS). Self-administered scale of 13 items used to assess the 3-dimensional pain-mapping construct: rumination, magnification and hopelessness. Low scores indicate a low catastrophization, and high values, high catastrophization.
- Coping Strategies Questionnaire (CSQ). Questionnaire composed of 42 items grouped in 7 scales of 6 items each. Each item is scored according to a scale of 7 points: deviation of attention, reinterpretation of pain sensations, ignorance of pain sensations, self-assertive coping, prayer and hope, catastrophism and increased level of activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients with medical diagnosis of congenital coagulopathies: hemophilia A, hemophilia B, or von Willebrand's disease
- •Patients over 18 years of age
- •Patients in a prophylactic or on demand regimen with FVIII / FIX concentrates
- •Patients that have accepted the informed consent document.
排除标准
- •Patients with neurological or cognitive disorders that prevent the comprehension of the questionnaires
- •Patients without capacity to walk autonomously or with orthosis
- •Patients without access to digital media to complement the measuring instruments.
结局指标
主要结局
Perception of joint pain
时间窗: Screening visit
Measurement with numerical scale of pain. The patient must assign pain to a numerical value between two extreme points (0 to 10). Although the subject is asked to use numerical values to indicate the level of pain, the use of keywords, as well as previous instructions, are necessary if the investigators expect the patient to conceptualize their pain in numerical terms. The scale is discrete, not continuous, but to perform statistical analyzes, equal intervals can be assumed between categories.
次要结局
- kinesiophobia(Screening visit)
- Perception of pain coping strategies(Screening visit)
- Perception of quality of life(Screening visit)
- Perception of anxiety(Screening visit)
- Perception of pain catastrophizing(Screening visit)
研究者
Rubén Cuesta-Barriuso, PhD
Principal Investigator
Real Fundación Victoria Eugenia