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临床试验/NCT02082951
NCT02082951已完成不适用

Family Empathic Behaviour Versus Nurse Empathic Behaviour: Comparison of Anxiety Symptoms in the Preoperative Cardiac Surgery Patients

Juliana de Lima Lopes2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2011年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
2
主要终点
The primary outcome was Anxiety.

研究概览

简要总结

The objective was to compare the frequency and intensity of symptoms of anxiety in patients of preoperative cardiac surgery who received empathic behaviour from nurse or family or those who received no specific type of empathic behaviour. This is a randomized clinical trial. The sample consisted of 66 patients in preoperative of cardiac surgery, who were divided in three groups: empathic behaviour by nurses, without specific empathic behaviour and by family. Anxiety was assessed at two time points: before and after the intervention. The instrument used was developed and validated, comprising 19 defining characteristics of the nursing diagnosis anxiety. The hypothesis is that the group who received empathic behaviour from nurse or family will reduce the anxiety.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

The primary outcome was Anxiety.

时间窗: Participants were followed for the duration of preoperative period, an expected average of 4 days.

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.

次要结局

未报告次要终点

研究者

发起方
Juliana de Lima Lopes
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Juliana de Lima Lopes

Juliana de Lima Lopes

Federal University of São Paulo

研究点 (2)

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