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RecruitingNCT07570277Updated May 6, 2026

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

An interventional study of Routine nursing and ITHBC-based self-management intervention for postoperative varicose veins in Varicose Veins, sponsored by Second Affiliated Hospital of Nanchang University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Second Affiliated Hospital of Nanchang University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Varicose Veins with a site in China — 7 open to participants now, 11 under way, none of them phase 3. Varicose Veins · China.

Planned enrollment
11th of 13
104 · median 180
Started
2025
the only one that year
No phase
13 of 23
5 open now
Primary completion
2026-05
later than 7 of 10 live
Registered
19th of 23
by date

Among the 23 studies in Varicose Veins with a site in China, this one is the 11th largest by planned enrollment of the 13 interventional ones that give a count, is the only one that started in 2025, is one of 13 with no phase, reaches primary completion later than 7 of the 10 other live ones, and was the 19th registered.

Varicose Veins

226 studies on the registry are indexed under Varicose Veins; 30 are open to participants now.

Browse Varicose Veins studies →

Open to participants now

7 of the 23 studies in Varicose Veins with a site in China are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 22 Varicose Veins studies recruiting now, 12 (55%) set no upper age limit and 4 (18%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Varicose Veins

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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;
  • and voluntary participation.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
104 participants (estimated)

Study arms

  • 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

  • Experimental
    Experimental group

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

Interventions

  • BehavioralRoutine 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

  • BehavioralITHBC-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.

06

What researchers measure

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

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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%."

    Time frame: 3 months post-intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2025 (actual). Primary completion is estimated for May 2026, 12 months after the start.

Of 62 non-industry interventional studies with no phase under Varicose Veins, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 12 months is below that.

Counting every sponsor, half of 72 studies reached it within 22 months; a quarter within 11 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2025
First posted
May 6, 2026
StartActual
May 15, 2025
Primary completionEst.
May 25, 2026
CompletionEst.
Jun 1, 2026
Last update
May 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07570277
Lead sponsor
Second Affiliated Hospital of Nanchang University
Responsible party
Sponsor
First posted
May 6, 2026
Start date
May 15, 2025
Primary completion
May 25, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
May 6, 2026

Study contacts

Yujin Yang
Contact
18979136718@163.com
86 18979136718

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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