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

NCT07787065 | Completed

• 1 other identifier: PR(AG)133/2020
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Disease

Keywords

Ultrasound-Guided Foam Sclerotherapy; Nursing Intervention; Advanced Practice Nursing; Venous Clinical Severity Score; Health-Related Quality of Life; CIVIQ-20

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Venous Clinical Severity Score at 6 Months

  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.

  Baseline and 6 months after the procedure

Secondary Outcomes (2)

• Change From Baseline in CIVIQ-20 Score at 6 Months

  Baseline and 6 months after the procedure

• Patient Satisfaction With Nursing Care Assessed Using the Baker Questionnaire

  At 6 months after the procedure

Study Arms (2)

Usual Care Group

NO INTERVENTION

Participants received the usual outpatient care associated with ultrasound-guided foam sclerotherapy. They did not receive the structured nursing intervention program evaluated in this study. The sclerotherapy procedure was part of their clinically indicated treatment and was not assigned by the study.

Nursing Intervention Group

EXPERIMENTAL

Participants received a structured nursing intervention program in addition to the usual outpatient care associated with ultrasound-guided foam sclerotherapy. 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.

Other: Structured Nursing Intervention Program

Interventions

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.

Nursing Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Official College of Nurses of Barcelona: collaborator

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2026
• First Posted: August 26, 2026
• Study Start: October 9, 2020
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)