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NCT Number: NCT07787065

Effectiveness of a Nursing Intervention Program for Patients Undergoing Ultrasound-Guided Foam Sclerotherapy

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.

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Key information

Conditions

Chronic Venous Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Structured Nursing Intervention Program

Other

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.

Primary outcomes

  1. Change From Baseline in Venous Clinical Severity Score at 6 Months

    Time frame: 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 outcomes

  1. Change From Baseline in CIVIQ-20 Score at 6 Months

    Time frame: 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.

  2. Patient Satisfaction With Nursing Care Assessed Using the Baker Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Official College of Nurses of Barcelona

Registry information

Official study title

Eficacia de un Programa de intervención Enfermera Para Pacientes Sometidos a Escleroterapia de Vena Safena Interna

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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