NCT07570277

Brief Summary

This study constructed a postoperative self-management nursing intervention program for VVLE patients based on the ITHBC theory, and explored the impact of this program on the patients' postoperative self-management ability, self-efficacy, complication rate and quality of life.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
May 2025Jun 2026

Study Start

First participant enrolled

May 15, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2026

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 6, 2026

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 11, 2025

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Self-Management Scale for Lower Extremity Varicose Veins

    This scale was developed by Wang Sumin et al in 2021. It consists of three dimensions: daily living, medical disease management, and self-management efficacy, with a total of 25 items. The scale adopts a 5-point Likert scoring system, with total scores ranging from 25 to 125. A higher score indicates a stronger self-management ability

    Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention

Secondary Outcomes (3)

  • Self-Efficiacy Scale for Chronic(SESC)

    Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention

  • ChronIc Venous dIsease quality of life Questionnaire(CIVIQ-20)

    Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention

  • Incidence of complications

    3 months post-intervention

Study Arms (2)

Routine nursing

PLACEBO COMPARATOR

After admission, the responsible nurse introduces the hospital's rules and regulations, conducts a routine assessment of the patient (including age, vital signs, weight, self-care ability, health history, etc.), assesses the psychological and social support status, proposes a nursing diagnosis and formulates nursing measures. (2) Complete the preoperative preparations before the operation and inform the patient of the preoperative precautions. (3) After the operation, explain the postoperative precautions, guide the patient to get out of bed and move around as soon as possible, and perform ankle pump exercises (such as extension, flexion, and circular rotation) while lying in bed. (4) Before (at) discharge, guide the patient to undergo stress therapy and exercise, and suggest changing bad living habits (such as standing or sitting for long periods, smoking and drinking, carrying heavy loads for long periods, crossing legs, etc.). Instruct the patient to take the medicine strictly as p

Behavioral: Routine nursing

Experimental group

EXPERIMENTAL
Behavioral: ITHBC-based self-management intervention for postoperative varicose veins

Interventions

Routine nursingBEHAVIORAL

After admission, the responsible nurse introduces the hospital's rules and regulations, conducts a routine assessment of the patient (including age, vital signs, weight, self-care ability, health history, etc.), assesses the psychological and social support status, proposes a nursing diagnosis and formulates nursing measures. (2) Complete the preoperative preparations before the operation and inform the patient of the preoperative precautions. (3) After the operation, explain the postoperative precautions, guide the patient to get out of bed and move around as soon as possible, and perform ankle pump exercises (such as extension, flexion, and circular rotation) while lying in bed. (4) Before (at) discharge, guide the patient to undergo stress therapy and exercise, and suggest changing bad living habits (such as standing or sitting for long periods, smoking and drinking, carrying heavy loads for long periods, crossing legs, etc.). Instruct the patient to take the medicine strictly as pr

Routine nursing

The postoperative self-management intervention for patients with varicose veins of the lower extremities based on the ITHBC theory is mainly carried out from the following four aspects: (1) Individualized assessment: including the assessment of patients' poor health behaviors, disease perception, and the stage of change the patients are in. (2) Based on the assessment results, provide targeted knowledge and belief education to patients: on the basis of increasing knowledge, help patients build confidence and motivation for recovery, enhance their knowledge and skills in dealing with diseases, and promote the establishment of disease management behaviors. (3) Set corresponding goals based on the patient's condition: Jointly formulate short-term rehabilitation goals with the patient, guide and supervise the establishment and maintenance of the patient's self-management behavior. (4) Creative social support: Create a supportive social environment for patients by providing supp.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • It meets the diagnostic criteria for varicose veins of the lower extremities in the "Chinese Guidelines for the Diagnosis and Treatment of Chronic Venous Diseases";
  • The first surgical treatment for varicose veins of the lower extremities was received;
  • Age \>18 years old;
  • The patient is conscious, has no language communication barriers, possesses certain reading and writing abilities, and is proficient in using intelligent devices;
  • Informed consent and voluntary participation.

You may not qualify if:

  • Secondary varicose veins of the lower extremities ;
  • Patients with a history of severe organ diseases or mental illness;
  • Patients with combined lower extremity arterial diseases, acute infections and malignant tumors;
  • Participate in other researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jang XI, 330006, China

RECRUITING

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

May 6, 2026

Study Start

May 15, 2025

Primary Completion (Estimated)

May 25, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 6, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations