Pain in Patients With Congenital Coagulopathies

NCT03499522 | Unknown

• 1 other identifier: He-Pain Situation
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Hemophilic arthropathy; Pain; Functional Disease Present; Quality of life; Anxiety; Stress; Coping strategies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Perception of pain coping strategies

  Screening visit

• Perception of quality of life

  Screening visit

• Perception of anxiety

  Screening visit

• kinesiophobia

  Screening visit

• Perception of pain catastrophizing

  Screening visit

Study Arms (1)

Observational group

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 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.

Other: Observational group

Interventions

Observational group OTHER

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 \[CSQ\].

Observational group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hemophilia attending in six hemophilia Associations into Spanish Federation of Hemophilia (Fedhemo).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Real Fundación Victoria Eugenia: lead

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Rubén Cuesta Barriuso

  Royal Victoria Eugenia Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubén Cuesta Barriuso, PhD

CONTACT

607547274; ruben.cuestab@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 17, 2018
• Study Start: May 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: February 1, 2019
• Last Updated: April 17, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share