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Effectiveness of Nursing Orientation for the Reduction of Anxiety and Stress

NCT ID: NCT03369873

Last Updated: 2017-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2016-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Syndrome

Keywords

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cardiac catheterization anxiety stress nursing orientation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients were randomized to one of two groups (control or intervention), according to the sequence determined by the Random System
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Nursing Orientation with guidance manual

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

Group Type EXPERIMENTAL

Guidance Manual

Intervention Type OTHER

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

Routine Nursing Orientation

The patients received the routine nursing orientation about cardiac catheterization.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Guidance Manual

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

Intervention Type OTHER

Other Intervention Names

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Routine Orientation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Juliana de Lima Lopes

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juliana de L Lopes, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

References

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Peterson JC, Link AR, Jobe JB, Winston GJ, Marina Klimasiewfski E, Allegrante JP. Developing self-management education in coronary artery disease. Heart Lung. 2014 Mar-Apr;43(2):133-9. doi: 10.1016/j.hrtlng.2013.11.006. Epub 2013 Nov 25.

Reference Type BACKGROUND
PMID: 24373484 (View on PubMed)

Reis RS, Hino AA, Anez CR. Perceived stress scale: reliability and validity study in Brazil. J Health Psychol. 2010 Jan;15(1):107-14. doi: 10.1177/1359105309346343.

Reference Type BACKGROUND
PMID: 20064889 (View on PubMed)

Wu KL, Chen SR, Ko WC, Kuo SY, Chen PL, Su HF, Chang WY. The effectiveness of an accessibility-enhanced multimedia informational educational programme in reducing anxiety and increasing satisfaction of patients undergoing cardiac catheterisation. J Clin Nurs. 2014 Jul;23(13-14):2063-73. doi: 10.1111/jocn.12469. Epub 2013 Dec 27.

Reference Type BACKGROUND
PMID: 24372795 (View on PubMed)

Murakami L, Rua ES, Santos VB, Lopes JL. Effectiveness of educational intervention with manual for anxiety and stress reduction: controlled clinical trial. Rev Bras Enferm. 2022 Sep 5;75Suppl 3(Suppl 3):e20210757. doi: 10.1590/0034-7167-2021-0757. eCollection 2022. English, Portuguese.

Reference Type DERIVED
PMID: 36074457 (View on PubMed)

Other Identifiers

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UNIFESP30

Identifier Type: -

Identifier Source: org_study_id