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Pain in Patients With Congenital Coagulopathies

NCT03499522 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2018-04-17

No results posted yet for this study

Summary

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.

Conditions

  • Hemophilia Arthropathy

Interventions

OTHER

Observational group

The dependent variables (pain, quality of life, anxiety and coping strategies) and the outcome measures used to measure these variables will be: * Numerical scale of pain * Short Form 36 Health Survey \[SF-36\]. * State-Trait Anxiety Inventory \[STAI\]. * Tampa Scale of Kinesiophofia \[TSK-11SV\]. * Pain catastrophizing scale \[PCS\]. * Coping Strategies Questionnaire \[CSQ\].

Sponsors & Collaborators

  • Real Fundación Victoria Eugenia

    lead OTHER

Principal Investigators

  • Rubén Cuesta Barriuso · Royal Victoria Eugenia Foundation

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2018-12-31
Completion
2019-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03499522 on ClinicalTrials.gov