- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
104
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yujin Yang
- Telefonnummer: 86 18979136718
- E-post: 18979136718@163.com
Studiesteder
-
-
Jang XI
-
Nanchang, Jang XI, Kina, 330006
- Rekruttering
- The Second Affiliated Hospital of Nanchang University
-
Ta kontakt med:
- Chunyan zheng
- Telefonnummer: 8618979136718
- E-post: zhengchunyan120@163.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Eksperimentell 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.
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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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
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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.
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Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
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Incidence of complications
Tidsramme: 3 months post-intervention
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"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%."
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3 months post-intervention
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
15. mai 2025
Primær fullføring (Antatt)
25. mai 2026
Studiet fullført (Antatt)
1. juni 2026
Datoer for studieregistrering
Først innsendt
11. juni 2025
Først innsendt som oppfylte QC-kriteriene
29. april 2026
Først lagt ut (Faktiske)
6. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. april 2026
Sist bekreftet
1. juni 2025
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IIT-I-2025-037
Plan for individuelle deltakerdata (IPD)
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NEI
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