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- Ensaio Clínico 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 de abril de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
104
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Yujin Yang
- Número de telefone: 86 18979136718
- E-mail: 18979136718@163.com
Locais de estudo
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Jang XI
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Nanchang, Jang XI, China, 330006
- Recrutamento
- The Second Affiliated Hospital of Nanchang University
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Contato:
- Chunyan zheng
- Número de telefone: 8618979136718
- E-mail: zhengchunyan120@163.com
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Grupo experimental
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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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Comparador de Placebo: 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
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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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Postoperative Self-Management Scale for Lower Extremity Varicose Veins
Prazo: Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
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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
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Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Self-Efficiacy Scale for Chronic(SESC)
Prazo: Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
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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)
Prazo: Baseline (pre-intervention), 1 month post-intervention, and 3 months post-intervention
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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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de maio de 2025
Conclusão Primária (Estimado)
25 de maio de 2026
Conclusão do estudo (Estimado)
1 de junho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
11 de junho de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de abril de 2026
Primeira postagem (Real)
6 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de abril de 2026
Última verificação
1 de junho de 2025
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IIT-I-2025-037
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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