Research on the Application of Nursing Intervention Based on ITHBC Theory in Postoperative Self-Management of Patients With Varicose Veins of the Lower Extremities

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.

Study Overview

• Status: Recruiting
• Conditions: Varicose Veins
• Intervention / Treatment: Behavioral: Routine nursing; Behavioral: ITHBC-based self-management intervention for postoperative varicose veins

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yujin Yang; Phone Number: 86 18979136718; Email: 18979136718@163.com

Study Locations

• China
  • Jang XI
    • Nanchang, Jang XI, China, 330006
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University
      • Contact: Chunyan zheng; Phone Number: 8618979136718; Email: zhengchunyan120@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Behavioral: ITHBC-based self-management intervention for postoperative varicose veins; 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.
Placebo Comparator: Routine nursing; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficiacy Scale for Chronic(SESC)	This scale was developed by Lorig et al and later adapted into Chinese by Zhang Meixia. The scale consists of 6 items, each scored from 1 to 10. The mean score of all items is used as the total score for self-efficacy, with a higher score indicating greater confidence.	Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
ChronIc Venous dIsease quality of life Questionnaire（CIVIQ-20）	This scale was developed by Launois et al. in 1996. It consists of four dimensions: physical function (4 items), psychological state (9 items), social activity (3 items), and pain level (4 items), with a total of 20 items. A 5-point Likert scale is used for scoring, with total scores ranging from 20 to 100. A lower score indicates a better quality of life.	Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
Incidence of complications	"Record and compare the incidence of complications such as limb swelling, skin ecchymosis, incision infection, DVT, and disease recurrence within three months after surgery between the two groups of patients. The complication rate = (number of cases with complications / total number of cases in each group) × 100%."	3 months post-intervention

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 11, 2025
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Varicose Veins
• Other Study ID Numbers: IIT-I-2025-037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No