Efficacy of Nursing Orientation to Reduce the Anxiety of Patients Undergoing Bed Bath
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|ClinicalTrials.gov Identifier: NCT01724762|
Recruitment Status : Completed
First Posted : November 12, 2012
Last Update Posted : November 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Other: Nursing Orientation||Not Applicable|
Patients with acute coronary syndrome present many physiological and psychological changes, especially anxiety, which can be more intense when the patient expects or experiences certain procedures, such as bed bath. The association of anxiety and acute myocardial infarction has shown negative impact on the prognosis of these patients. The anxiety causes activation of the sympathetic nervous system by increasing cardiac contractility, blood pressure, heart rate and oxygen consumption, worsening disease progression. Thus, minimizing the effects of patients' anxiety in the face of various nursing procedures is essential to quality care. The anxiety can be reduced using medications and/or nursing orientation.
This study was conducted in the Coronary Care Units, Brazilian Heart Institute. The study was divided into two phases. The first comprised the development and validation of an informative manual by nurses and patients. The manual was developed by the researchers and then submitted to validation by five nursing professors from the field of nursing fundamentals and five nurses with experience in coronary care units. The Delphi Technique was used to validate the manual in this phase. After validation by nurses, the manual was validated by 35 patients hospitalized in the coronary care unit who experienced bed bath at least once. A score above 4 should be achieved for the manual to be considered comprehensible and validated by patients. The statistical analysis at this phase was performed through the Wilcoxon rank-sum test and percentage of score 5 with its confidence interval. The study's second phase comprised assessment of the efficacy of nursing orientation to reduce the anxiety of patients with acute coronary syndrome undergoing bed baths. The sample population was composed of 120 patients with acute coronary syndrome hospitalized in coronary care units divided into two groups: control group (patients who did not read the informative manual concerning bed bath and received only the unit's routine information) and the intervention group (patients who received nursing orientation and read the informative manual concerning bed bath). The STAI-state was used to assess anxiety. It was applied immediately after informing the patients about the bed bath, immediately after orientation (intervention group) or immediately after the unit's routine information (control group), and immediately after the bath.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Efficacy of Nursing Orientation to Reduce the Anxiety of Patients With Acute Coronary Syndrome Undergoing Bed Bath|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Experimental: Nursing orientation
Patients who received nursing orientation and read the informative manual concerning bed bath
Other: Nursing Orientation
- STAI-state [ Time Frame: Participants were followed for the duration of hospital stay, an average of 2 weeks ]The STAI-state was applied immediately after informing the patients about the bed bath, immediately after orientation (intervention group) or immediately after the unit's routine information (control group), and immediately after the bath.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724762
|Federal University of São Paulo|
|São Paulo, Brazil, 04021-001|
|Principal Investigator:||Juliana L Lopes, Ms||Federal University of São Paulo|
|Study Director:||Alba LB Barros, PhD||Federal University of São Paulo|
|Study Director:||Luiz A Nogueira-Martins||Federal University of São Paulo|