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CompletedNCT03369873Updated Dec 13, 2017

Effectiveness of Nursing Orientation for the Reduction of Anxiety and Stress

An interventional study of Guidance Manual in Coronary Syndrome, sponsored by Federal University of São Paulo. Completed. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2017-12-13.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Syndrome

Keywords

  • cardiac catheterization
  • anxiety
  • stress
  • nursing orientation
03

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    Nursing Orientation with guidance manual

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

    Other: Guidance Manual

  • No intervention
    Routine Nursing Orientation

    The patients received the routine nursing orientation about cardiac catheterization.

Interventions

  • OtherGuidance Manual

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

    Also known as: Routine Orientation

05

What researchers measure

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.

    Time frame: The patients were followed for one day

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 24373484 ↗
  • 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. PubMed 20064889 ↗
  • 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. PubMed 24372795 ↗
  • 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. PubMed 36074457 ↗

Individual participant data

Plan to share: No — We not plan to make individual participant data avaiable to other researchers.

08

Registry details

Key details

Study ID
NCT03369873
Lead sponsor
Federal University of São Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Responsible party
Juliana de Lima Lopes (PhD, Federal University of São Paulo) — Principal investigator
First posted
Dec 12, 2017
Start date
Apr 1, 2016
Primary completion
Dec 1, 2016
Completion
Dec 1, 2016
Last update
Dec 13, 2017

Study contacts

Juliana de L Lopes, PhD
study director · Federal University of São Paulo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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