Effectiveness of Nursing Orientation for the Reduction of Anxiety and Stress

Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03369873
• Other study ID #: UNIFESP30
• Status: Completed
• Phase: N/A
• First received: December 7, 2017
• Last updated: December 11, 2017
• Start date: April 1, 2016
• Est. completion date: December 1, 2016

Study information

• Verified date: December 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

References & Publications (3)

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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