- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02082951
Family Empathic Behaviour Versus Nurse Empathic Behaviour
Family Empathic Behaviour Versus Nurse Empathic Behaviour: Comparison of Anxiety Symptoms in the Preoperative Cardiac Surgery Patients
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Primary outcome is anxiety. Anxiety was assessed by a nurse using of an instrument developed and validated previous, based on 19 defining characteristics described by NANDA-International for the nursing diagnosis anxiety: verbalization of fear (expressed concern); apprehension, nervousness, tension, restlessness, anxiety, anxious, insomnia, abnormal respiratory rate, increased pulse, dry mouth, increased perspiration, fatigue, cranky; voice / ends trembling, chest / abdominal pain, urinary urgency, nausea, and vomiting.
Patients were evaluated for the presence and absence of these anxiety symptoms through scores: 0 (no symptom) and 1 (presence of symptom). For analysis of the results was carried out the sum of the scores of each symptom, ranging from 0 to 21, with the higher the score, the greater was the anxiety symptoms presented by the patient.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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SP
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São Paulo, SP, Brasil, 04023-061
- Federal University of São Paulo
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Patients older than 18 years;
- Literate;
- Patient who agreed to participate in the study by signing the consent form at least 24 hours prior to surgery.
Exclusion Criteria:
- Patients with a history of surgery;
- Patients in preoperative cardiac transplantation;
- Patients who did not have at least two defining characteristics of the nursing diagnosis anxiety;
- Patients using anxiolytics;
- Smokers and / or patients who drank any amount of alcohol daily.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Group 2: empathic behaviour by family.
Considered the empathic behaviour performed by family as a hospital visit with greater than 45 minutes duration, a person with whom the patient had a good relationship, he considered it to be important and welcome.
It is emphasized that these families did not have any prior training and after the visit, patients were asked about how the visit had been seeking to detect the presence of any conversations that have been unpleasant for patients and, if present, the patients were excluded from the study.
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Considered the empathic behaviour performed by family as a hospital visit with greater than 45 minutes duration, a person with whom the patient had a good relationship, he considered it to be important and welcome.
It is emphasized that these families did not have any prior training and after the visit, patients were asked about how the visit had been seeking to detect the presence of any conversations that have been unpleasant for patients and, if present, the patients were excluded from the study.
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Experimental: Group 1: empathic behaviour by nurses.
The empathic behaviour in group 1 was performed by a trained nurse.
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The empathic behaviour in group 1 was performed by a trained nurse.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The primary outcome was Anxiety.
Prazo: Participants were followed for the duration of preoperative period, an expected average of 4 days.
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Anxiety was assessed by a nurse using an instrument developed and validated previous, based on 19 defining characteristics described by NANDA-International for the nursing diagnosis anxiety: verbalization of fear (expressed concern); apprehension, nervousness, tension, restlessness, anxiety, anxious, insomnia, abnormal respiratory rate, increased pulse, dry mouth, increased perspiration, fatigue, cranky; voice / ends trembling, chest / abdominal pain, urinary urgency, nausea, and vomiting. Patients were evaluated for the presence and absence of these anxiety symptoms through scores: 0 (no symptom) and 1 (presence of symptom). For analysis of the results was carried out the sum of the scores of each symptom, ranging from 0 to 21, with the higher the score, the greater was the anxiety symptoms presented by the patient. |
Participants were followed for the duration of preoperative period, an expected average of 4 days.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cinthia C Assis, PhD, Federal University
- Diretor de estudo: Luiz Antônio Nogueira-Martins, PhD, Federal University of São Paulo
- Cadeira de estudo: Alba Lucia BL Barros, PhD, Federal University of SãoPaulo
- Cadeira de estudo: Juliana L Lopes, PhD, Federal University of São Paulo
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UNIFESP23
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