Chronic Venous Disease
Conditions
Keywords
Ultrasound-Guided Foam Sclerotherapy, Nursing Intervention, Advanced Practice Nursing, Venous Clinical Severity Score, Health-Related Quality of Life, CIVIQ-20
Brief summary
Chronic venous disease can cause pain, swelling, functional limitations, and reduced health-related quality of life. Ultrasound-guided foam sclerotherapy is commonly used to treat venous insufficiency. This randomized controlled trial evaluated whether a structured nursing intervention program, in addition to usual care, improved clinical severity and health-related quality of life in adults undergoing ultrasound-guided foam sclerotherapy at Vall d'Hebron University Hospital. Participants were randomly assigned to usual care or to the nursing intervention program. The program included nursing assessment and education before the procedure, support during treatment, telephone follow-up on the following day, guidance on compression and self-care, access to telephone support, and scheduled follow-up. Clinical severity was assessed using the Venous Clinical Severity Score (VCSS), and health-related quality of life was evaluated using the Chronic Venous Insufficiency Questionnaire (CIVIQ-20). Satisfaction with care was also assessed in the intervention group.
Interventions
OTHERStructured Nursing Intervention Program
The structured nursing intervention program was delivered in addition to usual care. It included a nursing consultation before the procedure with clinical assessment and individualized education; support during the sclerotherapy procedure; telephone follow-up on the following day; guidance on compression therapy, self-care, and warning signs; access to telephone support; and scheduled follow-up at three weeks and six months. Ultrasound-guided foam sclerotherapy was clinically indicated background treatment and was not assigned by the study.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Official College of Nurses of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Two-arm parallel randomized controlled trial comparing a structured nursing intervention program plus usual care with usual care alone in patients undergoing ultrasound-guided foam sclerotherapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with chronic venous insufficiency undergoing ultrasound-guided sclerotherapy, with or without active lower-extremity ulcers. * Patients able to attend all scheduled sessions during the study period. * Patients who provided written informed consent after receiving
Exclusion criteria
* Patients who required hospital admission or discontinued participation during the study period. * Patients who, because of neurological, psychological, or psychiatric conditions, were unable to continue attending the scheduled sessions. Accepts Healthy Volunteers: No Sex: All Gender Based: No Minimum Age: 18 Years Maximum Age: No Limit (N/A)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Venous Clinical Severity Score at 6 Months | Baseline and 6 months after the procedure | Clinical severity was assessed using the Venous Clinical Severity Score (VCSS). The scale consists of 10 clinical domains scored from 0 to 3, producing a total score ranging from 0 to 30. Higher scores indicate greater venous disease severity. A decrease from baseline indicates clinical improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in CIVIQ-20 Score at 6 Months | Baseline and 6 months after the procedure | Health-related quality of life was assessed using the 20-item Chronic Venous Insufficiency Questionnaire (CIVIQ-20), which evaluates pain, physical, psychological, and social dimensions. The global score is transformed to a scale from 0 to 100, with higher scores indicating better health-related quality of life. A positive change from baseline indicates improvement. |
| Patient Satisfaction With Nursing Care Assessed Using the Baker Questionnaire | At 6 months after the procedure | Patient satisfaction was assessed using the 13-item Baker Consultation Satisfaction Questionnaire. The questionnaire was administered only to participants in the nursing intervention group because it evaluated satisfaction with the structured nursing intervention program, which was not received by the usual care group. Items are rated on a 5-point Likert scale and evaluate three dimensions: professional care, professional relationship, and consultation time. Items were coded according to the questionnaire scoring method, and mean scores were calculated for each dimension. Higher scores indicate greater satisfaction after accounting for reverse-scored items. |
Countries
Spain
Outcome results
None listed