Hemophilia Arthropathy Clinical Trial
Official title:
Situation and Characteristics of Pain in Patients With Congenital Coagulopathies in Spain
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.
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.
Subjects of the study Number and characteristics of the sample. The inclusion criteria to
participate in the present study are patients: with a medical diagnosis of congenital
coagulopathies (hemophilia A and B, or von Willebrand's disease); adults; in a prophylactic
or on demand regimen with FVIII / FIX concentrates; and that they have signed the informed
consent document. On the other hand, those patients with: neurological or cognitive
alterations that impede the comprehension of the questionnaires will be excluded from the
study; inability to walk autonomously or with an orthosis; and without access to digital
media to complement the measuring instruments.
It is expected to recruit a total of 80 patients for inclusion in the study. The sample size
is justified with respect to the prevalence of patients with hemophilia (2039 patients with
hemophilia A and B in Spain). Based on the established selection criteria (n = 678, according
to the census of the Spanish Federation of Hemophilia) the sample size at the national level
would be 151, with a level of confidence or 95% confidence and an expected proportion of
dropouts from the fifteen%. Thus, for the 6 regions of Spain where the study will be
developed, a sample of 80 patients is established for the established study period (April to
December 2018).
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