Varicose VeinsNCT07570277
Research on the Application of Nursing Intervention Based on ITHBC Theory in Postoperative Self-Management of Patients With Varicose Veins of the Lower Extremities
A study testing Routine nursing and ITHBC-based self-management intervention for postoperative varicose veins in people with Varicose Veins, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Routine nursing and ITHBC-based self-management intervention for postoperative varicose veins
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jang XI, 330006
Chunyan zheng, 8618979136718, zhengchunyan120@163.com
About this study
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.
- Conditions
- Varicose Veins
- Being tested
- Routine nursing, ITHBC-based self-management intervention for postoperative varicose veins
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine nursingBehavioural
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
ITHBC-based self-management intervention for postoperative varicose veinsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Routine nursing |
| Experimental group | Experimental | Not described Receives: Behavioral: ITHBC-based self-management intervention for postoperative varicose veins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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%."
Measured: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start15 May 2025
- Primary completion25 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570277
- Sponsor's protocol ID
- IIT-I-2025-037
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Application of Nursing Intervention Based on ITHBC Theory in Postoperative Self-Management of Patients With Varicose Veins of the Lower Extremities
- ClinicalTrials.gov ID
- NCT07570277
- Acronym / sponsor ID
- IIT-I-2025-037
- Conditions
- Varicose Veins
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine nursing | Placebo comparator | Behavioral: Routine nursingAfter 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 |
| Experimental group | Experimental | Behavioral: ITHBC-based self-management intervention for postoperative varicose veins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine nursingAfter 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 | Behavioural | Routine nursing |
| ITHBC-based self-management intervention for postoperative varicose veinsThe 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. | Behavioural | Experimental group |
Primary outcome
Postoperative Self-Management Scale for Lower Extremity Varicose Veins
Time frame: Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
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
3 secondary outcomes
Self-Efficiacy Scale for Chronic(SESC)
Time frame: Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
ChronIc Venous dIsease quality of life Questionnaire（CIVIQ-20）
Time frame: Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
Incidence of complications
Time frame: 3 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine nursing and ITHBC-based self-management intervention for postoperative varicose veins in people with Varicose Veins, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yujin Yang (86 18979136718, 18979136718@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Self-Management Scale for Lower Extremity Varicose Veins (time frame: Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.