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临床试验/NCT03369873
NCT03369873已完成不适用

Effectiveness of Nursing Orientation for the Reduction of Anxiety and Stress of Patients That Waiting Cardiac Catheterization: Randomized Clinical Trial.

Federal University of São Paulo0 个研究点目标入组 122 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
122
主要终点
Change from score of anxiety and stress

研究概览

简要总结

This study´s objective was to identify the effectiveness of nursing orientation for the reduction of anxiety and stress of patients that was waiting cardiac catheterization. Method. This is a randomized clinical trial. The sample consisted of patients that was waiting cardiac catheterization who were divided into two groups: intervention group (patients who received nursing orientation with a validated guidance manual about this procedure) and control group (patients who received the routine nursing orientation). The primary end points were the anxiety and stress, which was evaluated in two moments (before and after the nursing orientation). The State Anxiety Inventory (STAI-state) was used to assess anxiety and the Perceived Stress Scale (PSS-10) was used to assess stress. Prior to the collection, the research project was submitted to the Research Ethics Committee and the data was collected after its approval.

详细描述

This study´s objective was to identify the effectiveness of nursing orientation for the reduction of anxiety and stress of patients that was waiting cardiac catheterization. Method. This is a randomized clinical trial. The sample consisted of patients that was waiting cardiac catheterization who were divided into two groups: intervention group (patients who received nursing orientation with a validated guidance manual about this procedure) and control group (patients who received the routine nursing orientation). The subjects were consulted about the desire to participate, and those who agreed, signed the consent form. The patients were randomized to one of two groups (control or intervention), according to the sequence determined by the Random System. Randomization was carried out by a teacher who did not participate of any phase of this study. After randomization, the patients were instructed how to fill out the instruments. The primary end points were the anxiety and stress, which was evaluated in two moments (before and after the nursing orientation). The State Anxiety Inventory (STAI-state) was used to assess anxiety and the Perceived Stress Scale (PSS-10) was used to assess stress. Subsequent to this first evaluation, the patients, both in the control group and in the intervention group, received the intervention by another profissional. After the patients were evaluated about anxiety and stress. Prior to the collection, the research project was submitted to the Research Ethics Committee and the data was collected after its approval.

研究设计

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

盲法说明

The profissional that evaluated the patients, was not informed if the patients were of the control or intervention group. The outcomes assessor was not informed if the group 1 and 2 was control or intervention group.

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Minimum 18 years
  • Stable patients in Killip I and II
  • Maximum 79 years

排除标准

  • Hemodynamic instability
  • Precordial pain
  • Patients who undergo emergency cardiac catheterization
  • Patients with visual deficit and / or with some alteration of the level of consciousness
  • Patients using benzodiazepine, anxiolytic and / or herbal medicines
  • Situations that patient received orientation about the procedure prior to initiation of the current hospitalization survey and / or when reporting that they do not wish to receive information.

研究组 & 干预措施

Nursing Orientation with guidance manual

Experimental

The patients received the nursing orientation with validated guidance manual of cardiac catheterization.

干预措施: Guidance Manual (Other)

Routine Nursing Orientation

No Intervention

The patients received the routine nursing orientation about cardiac catheterization.

结局指标

主要结局

Change from score of anxiety and stress

时间窗: The patients were followed for one day

The anxiety and stress were evaluated using the State Anxiety Inventory (STAI-state) and the Perceived Stress Scale (PSS-10), immediately before and after interventions. The STAI -state consists of 20 items, with Likert responses ranging from 1 (Absolutely not) to 4 (Very High), obtaining values from 20 to 80 points, that the higher the score, the greater the patient's anxiety. Anxiety was categorized as follows: low anxiety (20-34 points), moderate anxiety (35-49 points), high anxiety (50-64 points) and very high anxiety (65-80 points). The PSS-10 has 10 items, whose score varies from 0 to 40 points, and the higher the scores, the greater the perceived stress of the patient.

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

PhD

Federal University of São Paulo

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