- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07570277
Research on the Application of Nursing Intervention Based on ITHBC Theory in Postoperative Self-Management of Patients With Varicose Veins of the Lower Extremities
29. april 2026 opdateret af: Second Affiliated Hospital of Nanchang University
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.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
104
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yujin Yang
- Telefonnummer: 86 18979136718
- E-mail: 18979136718@163.com
Studiesteder
-
-
Jang XI
-
Nanchang, Jang XI, Kina, 330006
- Rekruttering
- The Second Affiliated Hospital of Nanchang University
-
Kontakt:
- Chunyan zheng
- Telefonnummer: 8618979136718
- E-mail: zhengchunyan120@163.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Eksperimentel gruppe
|
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 komparator: 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
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative Self-Management Scale for Lower Extremity Varicose Veins
Tidsramme: 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
|
Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-Efficiacy Scale for Chronic(SESC)
Tidsramme: Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
|
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)
Tidsramme: Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
|
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
Tidsramme: 3 months post-intervention
|
"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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. maj 2025
Primær færdiggørelse (Anslået)
25. maj 2026
Studieafslutning (Anslået)
1. juni 2026
Datoer for studieregistrering
Først indsendt
11. juni 2025
Først indsendt, der opfyldte QC-kriterier
29. april 2026
Først opslået (Faktiske)
6. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. april 2026
Sidst verificeret
1. juni 2025
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIT-I-2025-037
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Åreknuder
-
Kafrelsheikh UniversityAktiv, ikke rekrutterendeÅreknuder i underekstremiteterne | Great Saphenous Vein (GSV) med venøs reflukssygdomEgypten
-
Medtronic EndovascularAfsluttetGreat Saphenous Vein (GSV) med venøs reflukssygdomForenede Stater
-
Medtronic EndovascularSapheon, Inc.AfsluttetGreat Saphenous Vein (GSV) med venøs reflukssygdomForenede Stater
-
Novartis PharmaceuticalsAfsluttetMakulaødem Sekundært til Branch Retinal Vein Oklusion (BRVO)Japan
-
Moscow City Hospital named after A.K. EramishantsevPirogov Russian National Research Medical University; Vishnevsky Center...AfsluttetÅreknuder | Venøs refluks | Kronisk venøs insufficiens (CVI) | Kronisk venøs lidelse | Great Saphenous Vein (GSV) med venøs reflukssygdomDen Russiske Føderation
Kliniske forsøg med Routine nursing
-
Hospital Clinic of BarcelonaAfsluttet
-
Ege Miray TopcuAfsluttetAngst | Sygeplejerskestyret støttende pleje | SygeplejepersonaleTyrkiet (Türkiye)
-
Jouf UniversityAfsluttetKirurgi | Pædiatrisk ALT | Sygeplejerskens rolleEgypten
-
Kocaeli UniversityAfsluttetPostoperative komplikationer | Sygeplejerskens rolle | Klinisk forringelseKalkun
-
National Taipei University of Nursing and Health...Tilmelding efter invitationForudsigelse af højrisikopopulationer for sarkopeniTaiwan
-
Washington University School of MedicineAfsluttetSeptisk chok | Alvorlig sepsis | Åndedrætsstop | Hjerte-lungearrest | Optrapning af plejeForenede Stater
-
Taizhou Hospital of Traditional Chinese MedicineAfsluttetKritisk syge patienter | Gastrointestinal blødning | Ernæringsstøtte | Lungeinfektioner | Akut nyreskade (AKI)Kina
-
The First Hospital of Hebei Medical UniversityAfsluttet
-
National University of SingaporeIkke rekrutterer endnuDepression | Fysisk aktivitet | Stress | Angst | Modstandsdygtighed | Praksis parathed | Spiseadfærd
-
The Fourth Affiliated Hospital of Zhejiang University...Rekruttering