Clinical trial NCT03369873: Effectiveness of Nursing Orientation for the Reduction of Anxiety and Stress
Official title: Effectiveness of Nursing Orientation for the Reduction of Anxiety and Stress of Patients That Waiting Cardiac Catheterization: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Syndrome
Keywords: cardiac catheterization
anxiety
stress
nursing orientation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2017-12-12
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were randomized to one of two groups (control or intervention), according to the sequence determined by the Random System
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from score of anxiety and stress
timeFrame: The patients were followed for one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Juliana de L Lopes, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
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.
citation: 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.