- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02156284
Nurse Empathic Behaviour to Reduce the Fear in Patients of Preoperative Cardiac Surgery
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Primary outcome is fear. Fear was assessed by a nurse using of an instrument developed and validated previous, based on 15 defining characteristics described by North American Nursing Diagnosis Association for the nursing diagnosis fear: apprehension, increased tension, exciting, nervousness, verbalization of fear (expressed concern), increased pulse, nausea, vomiting, fatigue, abnormal respiratory rate, increased perspiration, dry mouth, fear of death (reported), crying and impaired bowel motility.
Patients were evaluated for the presence and absence of these fear 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 15, with the higher the score, the greater was the fear symptoms presented by the patient.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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
- Patient who agreed to participate in the study by signing the consent form at least 24 hours prior to surgery
Exclusion Criteria:
- Patients in preoperative cardiac transplantation
- Patients who did not have at least two defining characteristics of the nursing diagnosis fear
- 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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Empathic behaviour by nurses
Patients who received empathic behaviour was performed by a trained nurse.
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Control group: patients without specific empathic behaviour Intervention group: patients who received the empathic behaviour was performed by a trained nurse. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The primary outcome was Fear.
Periodo de tiempo: Participants were followed for the duration of preoperative period, an expected average of 4 days.
|
Fear was assessed by a nurse using an instrument developed and validated previous, based on 15 defining characteristics described by North American Nursing Diagnosis Association for the nursing diagnosis fear: apprehension, increased tension, exciting, nervousness, verbalization of fear (expressed concern), increased pulse, nausea, vomiting, fatigue, abnormal respiratory rate, increased perspiration, dry mouth, fear of death (reported), crying and impaired bowel motility. Patients were evaluated for the presence and absence of these fear 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 15, with the higher the score, the greater was the fear 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
- Silla de estudio: Juliana L Lopes, PhD, Federal University of São Paulo
- Investigador principal: Juliana S Jurko, Federal University of São Paulo
- Director de estudio: Alba Lucia B L Barros, PhD, Federal University of São Paulo
- Silla de estudio: Cinthia C Assis, 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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- U111111568736
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