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临床试验/NCT01724762
NCT01724762已完成不适用

Evaluation of the Efficacy of Nursing Orientation to Reduce the Anxiety of Patients With Acute Coronary Syndrome Undergoing Bed Bath

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年4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
120
试验地点
2
主要终点
STAI-state

研究概览

简要总结

This study's general objective was to evaluate the efficacy of nursing orientation to reduce the anxiety of patients with acute coronary syndrome undergoing bed bath. The specific objectives included: the development and validation of an informative manual concerning bed bath; correlation of physiological variables (systolic and diastolic blood pressure and heart and respiratory rate) with the patients' state anxiety; correlation of antecedent variables (age, gender, cardiovascular risk factor, use of beta blockers, trait anxiety, depression, prior hospitalization, prior experience with bed baths, the patients' preference for a female or male professional to perform the bath, pain, fear, and embarrassment) with the patients' state anxiety.

详细描述

Patients with acute coronary syndrome present many physiological and psychological changes, especially anxiety, which can be more intense when the patient expects or experiences certain procedures, such as bed bath. The association of anxiety and acute myocardial infarction has shown negative impact on the prognosis of these patients. The anxiety causes activation of the sympathetic nervous system by increasing cardiac contractility, blood pressure, heart rate and oxygen consumption, worsening disease progression. Thus, minimizing the effects of patients' anxiety in the face of various nursing procedures is essential to quality care. The anxiety can be reduced using medications and/or nursing orientation.

This study was conducted in the Coronary Care Units, Brazilian Heart Institute. The study was divided into two phases. The first comprised the development and validation of an informative manual by nurses and patients. The manual was developed by the researchers and then submitted to validation by five nursing professors from the field of nursing fundamentals and five nurses with experience in coronary care units. The Delphi Technique was used to validate the manual in this phase. After validation by nurses, the manual was validated by 35 patients hospitalized in the coronary care unit who experienced bed bath at least once. A score above 4 should be achieved for the manual to be considered comprehensible and validated by patients. The statistical analysis at this phase was performed through the Wilcoxon rank-sum test and percentage of score 5 with its confidence interval. The study's second phase comprised assessment of the efficacy of nursing orientation to reduce the anxiety of patients with acute coronary syndrome undergoing bed baths. The sample population was composed of 120 patients with acute coronary syndrome hospitalized in coronary care units divided into two groups: control group (patients who did not read the informative manual concerning bed bath and received only the unit's routine information) and the intervention group (patients who received nursing orientation and read the informative manual concerning bed bath). The STAI-state was used to assess anxiety. It was applied immediately after informing the patients about the bed bath, immediately after orientation (intervention group) or immediately after the unit's routine information (control group), and immediately after the bath.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of acute coronary syndrome Killip 1
  • Patients who were undergoing the bed bath for the first time in the current hospitalization
  • Literate and at least 4 years of study
  • Patients with age less than 75 years
  • Patients who agreed to participate

排除标准

  • Patients with vascular diseases or arteriovenous fistulas in the left arm
  • Situations that could influence patients' anxiety and / or vital signs (arrhythmias such as ventricular tachycardia, second or third-degree atrioventricular block ; ischemic pain before, during or after bath; patients with Killip 2, 3 and 4; invasive procedures on the day of data collection, such as catheterization and surgery, and use of benzodiazepines and / or anxiolytics
  • Situations in which patients were not able to complete the questionnaires (altered level of consciousness, visual impairment and / or patients who could not read and / or write)
  • Situations in which the patient requested information about bed bath, previously the beginning of the evaluation.

结局指标

主要结局

STAI-state

时间窗: Participants were followed for the duration of hospital stay, an average of 2 weeks

The STAI-state was applied immediately after informing the patients about the bed bath, immediately after orientation (intervention group) or immediately after the unit's routine information (control group), and immediately after the bath.

次要结局

未报告次要终点

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juliana de Lima Lopes

Master Degree

Federal University of São Paulo

研究点 (2)

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