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NCT Number: NCT03369873

Effectiveness of Nursing Orientation for the Reduction of Anxiety and Stress

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Guidance Manual

Other

The intervention group received of nursing orientation using a validated guidance manual about cardiac catheterization.

Other names: Routine Orientation

Primary outcomes

  1. Change from score of anxiety and stress

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 12, 2017
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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