Hemophilia Arthropathy Clinical Trial
— He-PainSitOfficial 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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | February 1, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Real Fundación Victoria Eugenia |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perception of joint pain | 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. | Screening visit | |
Secondary | Perception of pain coping strategies | Measurement with Coping Strategies Questionnaire [CSQ]. Questionnaire composed of 42 items grouped in 7 scales of 6 items each, plus 2 items referring to the control exercised over pain and the ability to reduce it. Each item is scored according to a scale of 7 points (0 = never, 3 = sometimes, 6 = always). The scales included in this measuring instrument are: deviation of attention, reinterpretation of pain sensations, ignoring pain sensations, self-assertive coping, prayer and hope, catastrophism and increased level of activity. | Screening visit | |
Secondary | Perception of quality of life | Measurement with Short Form 36 Health Survey [SF-36]. This health questionnaire is one of the most widely used, validated and translated instruments in the field of measuring the quality of life related to health. The SF-36 health questionnaire is a generic instrument consisting of 36 questions, which provides a profile of the health status and is applicable to both patients and the healthy population. The questionnaire covers 8 dimensions: physical functioning, physical role, corporal pain, general health, vitality, social functioning, emotional role and mental health of the patient. | Screening visit | |
Secondary | Perception of anxiety | Measurement with State-Trait Anxiety Inventory [STAI]. This generic measurement instrument evaluates the current level of anxiety and the predisposition of the person to respond to stress. The STAI scale consists of two sections: the A-state scale contains 20 elements with which the patient can express how they feel at a given time and in the A-trait sscala, which also includes 20 elements, the subject can indicate how they feel. feel in general. The score for each scale can range from 0-30, indicating higher scores, higher levels of anxiety. | Screening visit | |
Secondary | kinesiophobia | Measurement with 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. | Screening visit | |
Secondary | Perception of pain catastrophizing | Measurement with Pain catastrophizing scale [PCS]. This self-administered scale of 13 items is one of the most used to assess the construct catrastofización before pain. It includes 3 dimensions: rumination, magnification and despair. The theoretical range of the instrument is between 13 and 62, indicating low scores a low catastrophization, and high values, high catastrophizing. | Screening visit |
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