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Effectiveness of Nursing Orientation for the Reduction of Anxiety and Stress

Sponsor
Federal University of São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT03369873
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)
122
Enrollment
2
Arms
8
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Guidance Manual
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The patients were randomized to one of two groups (control or intervention), according to the sequence determined by the Random SystemThe patients were randomized to one of two groups (control or intervention), according to the sequence determined by the Random System
Masking:
Single (Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Other
Official Title:
Effectiveness of Nursing Orientation for the Reduction of Anxiety and Stress of Patients That Waiting Cardiac Catheterization: Randomized Clinical Trial.
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nursing Orientation with guidance manual

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

Other: Guidance Manual
The intervention group received of nursing orientation using a validated guidance manual about cardiac catheterization.
Other Names:
  • Routine Orientation

    		•
    No Intervention: Routine Nursing Orientation

    The patients received the routine nursing orientation about cardiac catheterization.

    Outcome Measures

    Primary Outcome Measures

    1. Change from score of anxiety and stress [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Federal University of São Paulo
    • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    Investigators

    • Study Director: Juliana de L Lopes, PhD, Federal University of São Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Juliana de Lima Lopes, PhD, Federal University of São Paulo
    ClinicalTrials.gov Identifier:
    NCT03369873
    Other Study ID Numbers:
    • UNIFESP30
    First Posted:
    Dec 12, 2017
    Last Update Posted:
    Dec 13, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Juliana de Lima Lopes, PhD, Federal University of São Paulo
    cardiac catheterization
    anxiety
    stress
    nursing orientation
    Additional relevant MeSH terms:
    Anxiety Disorders

    Study Results

    No Results Posted as of Dec 13, 2017