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- Registro de ensayos clínicos de EE. UU.
- Ensayo 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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SP
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São Paulo, SP, Brasil, 04023-061
- Federal University of São Paulo
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The primary outcome was Anxiety.
Periodo de tiempo: 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.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cinthia C Assis, PhD, Federal University
- Director de estudio: Luiz Antônio Nogueira-Martins, PhD, Federal University of São Paulo
- Silla de estudio: Alba Lucia BL Barros, PhD, Federal University of SãoPaulo
- Silla de estudio: Juliana L Lopes, PhD, Federal University of São Paulo
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UNIFESP23
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