Ignite Creation Date:
2024-05-06 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03499522
Status:
UNKNOWN
Last Update Posted:
2018-04-17
First Post:
2018-04-11
Brief Title:
Pain in Patients With Congenital Coagulopathies
Sponsor:
Real Fundación Victoria Eugenia
Organization:
Real Fundación Victoria Eugenia
Study Overview
Official Title:
Situation and Characteristics of Pain in Patients With Congenital Coagulopathies in Spain
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
He-PainSit
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 Willebrands 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
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 Willebrands 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
Detailed Description:
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 Willebrands disease of age and to identify the ingestion and administration of analgesic drugs in patients with hemophilia or von Willebrands 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 Willebrands 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
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 Willebrands disease of age and to identify the ingestion and administration of analgesic drugs in patients with hemophilia or von Willebrands 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 Willebrands 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None