Effectiveness of Nursing Orientation for the Reduction of Anxiety and Stress

NCT03369873 | Completed

• 1 other identifier: UNIFESP30
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Syndrome

Keywords

cardiac catheterization; anxiety; stress; nursing orientation

Outcome Measures

Primary Outcomes (1)

• Change from score of anxiety and stress

  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.

  The patients were followed for one day

Study Arms (2)

Nursing Orientation with guidance manual

EXPERIMENTAL

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

Other: Guidance Manual

Routine Nursing Orientation

NO INTERVENTION

The patients received the routine nursing orientation about cardiac catheterization.

Interventions

Guidance Manual OTHER

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

Also known as: Routine Orientation

Nursing Orientation with guidance manual

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (4)

• 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.

  PMID: 24373484 BACKGROUND

• 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.

  PMID: 20064889 BACKGROUND

• 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.

  PMID: 24372795 BACKGROUND

• 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.

  PMID: 36074457 DERIVED

MeSH Terms

Conditions

Angina, Unstable; Anxiety Disorders

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Juliana de L Lopes, PhD

  Federal University of São Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: The patients were randomized to one of two groups (control or intervention), according to the sequence determined by the Random System

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 12, 2017
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 13, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share