Sponsor study identifier
observational
109
1 country
1
Study Start
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 3, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Introduction: Haemophilia is a congenital coagulopathy characterised by haemarthrosis, mainly in the knees, ankles and elbows. Prophylactic treatment is the most effective therapeutic option for preventing or minimising these bleeds. Bispecific monoclonal antibodies have been shown to be effective in reducing bleeding in patients with haemophilia. Objectives: To investigate the associations between chronic residual pain and pain catastrophising, perceived self-efficacy regarding the disease and treatment, and body image and perception of visible disability. Methods. Multicentre cross-sectional cohort studies. 109 patients with severe haemophilia A from different regions of Spain will be included in the study. The primary variable will be chronic residual pain and its functional interference (Brief Pain Inventory-Short Form). Secondary variables will be pain catastrophising (Pain Catastrophising Scale), perceived self-efficacy regarding the disease and treatment (Pain Self-Efficacy Questionnaire), and body image and perception of visible disability (Body Image Scale). Potential confounding variables will include sociodemographic variables (age and educational level), clinical variables (time on monoclonal antibody treatment and number of previous bleeds in the last 12 months) and anthropometric variables (body mass index). Expected results: It is expected that residual chronic pain will persist in patients with severe haemophilia A treated with monoclonal antibodies and that it will be associated with greater catastrophising, lower self-efficacy and poorer body image, modulating the experience of pain beyond bleeding control.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 24, 2025
Actual (reported)July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 31, 2025
Actual (reported)October 3, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Assessment of residual chronic pain and its functional interference at the time of the study.
Chronic residual pain and its functional interference will be assessed using the Spanish version of the Brief Pain Inventory-Short Form (BPI-SF). This multidimensional self-administered questionnaire explores pain intensity using four items: maximum, minimum, average and current pain, on a scale of 0-10. The degree of interference of pain in daily life is assessed using seven items: mood, activity, work, relationships, sleep, enjoyment of life, and walking, on a scale of 0-10. An average score is calculated for each dimension (intensity and interference). This instrument has shown excellent reliability and validity
Screening visit
Assessment of catastrophising at the time of the study.
Screening visit
Assessment of perceived self-efficacy for managing chronic pain at the time of the study.
Screening visit
Assessment of body image perception at the time of the study.
Screening visit
Assessment of the sociodemographic variable age at the time of the study.
Screening visit
Assessment of the sociodemographic variable educational level at the time of the study.
Screening visit
Assessment of the clinical variable time with prophylactic treatment with bispecific monoclonal antibodies at the time of the study.
Screening visit
Patients with severe haemophilia A from different regions of Spain will be included in the study. Patients who meet the selection criteria will be informed of the characteristics and objectives of the study. They will be provided with an information and informed consent document. After confirming that they do not meet any of the exclusion criteria, the primary and secondary dependent variables and confounding factors will be assessed
Patients with haemophilia who meet the selection criteria will be informed of the characteristics of the study and the objectives to be achieved. Subjects included in the study will be required to complete a workbook containing a series of questionnaires designed to assess chronic residual pain and pain catastrophising, perceived self-efficacy in relation to the disease and treatment, and body image and perception of visible disability in patients with haemophilia.
Universidad de Oviedo
Oviedo, Principality of Asturias, 33006, Spain
Rubén Cuesta-Barriuso, PhD
Universidad de Oviedo
First Submitted
July 24, 2025
First Posted
July 31, 2025
Study Start
July 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 3, 2025
The Safety of Emicizumab SC Injection in Korean Hemophilia A Patients With/Without FVIII Inhibitors
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 1, 2025
Record last verified: 2025-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: