<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01724762</url>
  </required_header>
  <id_info>
    <org_study_id>UNIFESP0447</org_study_id>
    <nct_id>NCT01724762</nct_id>
  </id_info>
  <brief_title>Efficacy of Nursing Orientation to Reduce the Anxiety of Patients Undergoing Bed Bath</brief_title>
  <official_title>Evaluation of the Efficacy of Nursing Orientation to Reduce the Anxiety of Patients With Acute Coronary Syndrome Undergoing Bed Bath</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study's general objective was to evaluate the efficacy of nursing orientation to reduce&#xD;
      the anxiety of patients with acute coronary syndrome undergoing bed bath. The specific&#xD;
      objectives included: the development and validation of an informative manual concerning bed&#xD;
      bath; correlation of physiological variables (systolic and diastolic blood pressure and heart&#xD;
      and respiratory rate) with the patients' state anxiety; correlation of antecedent variables&#xD;
      (age, gender, cardiovascular risk factor, use of beta blockers, trait anxiety, depression,&#xD;
      prior hospitalization, prior experience with bed baths, the patients' preference for a female&#xD;
      or male professional to perform the bath, pain, fear, and embarrassment) with the patients'&#xD;
      state anxiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with acute coronary syndrome present many physiological and psychological changes,&#xD;
      especially anxiety, which can be more intense when the patient expects or experiences certain&#xD;
      procedures, such as bed bath. The association of anxiety and acute myocardial infarction has&#xD;
      shown negative impact on the prognosis of these patients. The anxiety causes activation of&#xD;
      the sympathetic nervous system by increasing cardiac contractility, blood pressure, heart&#xD;
      rate and oxygen consumption, worsening disease progression. Thus, minimizing the effects of&#xD;
      patients' anxiety in the face of various nursing procedures is essential to quality care. The&#xD;
      anxiety can be reduced using medications and/or nursing orientation.&#xD;
&#xD;
      This study was conducted in the Coronary Care Units, Brazilian Heart Institute. The study was&#xD;
      divided into two phases. The first comprised the development and validation of an informative&#xD;
      manual by nurses and patients. The manual was developed by the researchers and then submitted&#xD;
      to validation by five nursing professors from the field of nursing fundamentals and five&#xD;
      nurses with experience in coronary care units. The Delphi Technique was used to validate the&#xD;
      manual in this phase. After validation by nurses, the manual was validated by 35 patients&#xD;
      hospitalized in the coronary care unit who experienced bed bath at least once. A score above&#xD;
      4 should be achieved for the manual to be considered comprehensible and validated by&#xD;
      patients. The statistical analysis at this phase was performed through the Wilcoxon rank-sum&#xD;
      test and percentage of score 5 with its confidence interval. The study's second phase&#xD;
      comprised assessment of the efficacy of nursing orientation to reduce the anxiety of patients&#xD;
      with acute coronary syndrome undergoing bed baths. The sample population was composed of 120&#xD;
      patients with acute coronary syndrome hospitalized in coronary care units divided into two&#xD;
      groups: control group (patients who did not read the informative manual concerning bed bath&#xD;
      and received only the unit's routine information) and the intervention group (patients who&#xD;
      received nursing orientation and read the informative manual concerning bed bath). The&#xD;
      STAI-state was used to assess anxiety. It was applied immediately after informing the&#xD;
      patients about the bed bath, immediately after orientation (intervention group) or&#xD;
      immediately after the unit's routine information (control group), and immediately after the&#xD;
      bath.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2010</start_date>
  <completion_date type="Actual">October 2011</completion_date>
  <primary_completion_date type="Actual">October 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>STAI-state</measure>
    <time_frame>Participants were followed for the duration of hospital stay, an average of 2 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Nursing orientation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who received nursing orientation and read the informative manual concerning bed bath</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nursing Orientation</intervention_name>
    <description>Control group: patients who did not read the informative manual concerning bed bath and received only the unit's routine information&#xD;
Intervention group: patients who received nursing orientation and read the informative manual concerning bed bath</description>
    <arm_group_label>Nursing orientation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of acute coronary syndrome Killip 1&#xD;
&#xD;
          -  Patients who were undergoing the bed bath for the first time in the current&#xD;
             hospitalization&#xD;
&#xD;
          -  Literate and at least 4 years of study&#xD;
&#xD;
          -  Patients with age less than 75 years&#xD;
&#xD;
          -  Patients who agreed to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with vascular diseases or arteriovenous fistulas in the left arm&#xD;
&#xD;
          -  Situations that could influence patients' anxiety and / or vital signs (arrhythmias&#xD;
             such as ventricular tachycardia, second or third-degree atrioventricular block ;&#xD;
             ischemic pain before, during or after bath; patients with Killip 2, 3 and 4; invasive&#xD;
             procedures on the day of data collection, such as catheterization and surgery, and use&#xD;
             of benzodiazepines and / or anxiolytics&#xD;
&#xD;
          -  Situations in which patients were not able to complete the questionnaires (altered&#xD;
             level of consciousness, visual impairment and / or patients who could not read and /&#xD;
             or write)&#xD;
&#xD;
          -  Situations in which the patient requested information about bed bath, previously the&#xD;
             beginning of the evaluation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juliana L Lopes, Ms</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of São Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alba LB Barros, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Federal University of São Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luiz A Nogueira-Martins</last_name>
    <role>Study Director</role>
    <affiliation>Federal University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of São Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>04021-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://www.heart.org/HEARTORG/</url>
    <description>American Heart Association</description>
  </link>
  <results_reference>
    <citation>Lopes Jde L, Nogueira-Martins LA, Goncalves MA, de Barros AL. Comparing levels of anxiety during bed and shower baths in patients with acute myocardial infarction. Rev Lat Am Enfermagem. 2010 Mar-Apr;18(2):217-23. doi: 10.1590/s0104-11692010000200012.</citation>
    <PMID>20549121</PMID>
  </results_reference>
  <results_reference>
    <citation>Barsevick A, Llewellyn J. A comparison of the anxiety-reducing potential of two techniques of bathing. Nurs Res. 1982 Jan-Feb;31(1):22-7.</citation>
    <PMID>6922456</PMID>
  </results_reference>
  <results_reference>
    <citation>Tel H, Tel H. The effect of individualized education on the transfer anxiety of patients with myocardial infarction and their families. Heart Lung. 2006 Mar-Apr;35(2):101-7. doi: 10.1016/j.hrtlng.2005.09.001.</citation>
    <PMID>16543038</PMID>
  </results_reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>November 9, 2012</last_update_submitted>
  <last_update_submitted_qc>November 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Juliana de Lima Lopes</investigator_full_name>
    <investigator_title>Master Degree</investigator_title>
  </responsible_party>
  <keyword>Baths</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Acute Coronary Syndrome</keyword>
  <keyword>Education, Nursing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01724762
org study id: UNIFESP0447
nct id: NCT01724762
lead sponsor: 
collaborator: 
has dmc: No
This study's general objective was to evaluate the efficacy of nursing orientation to reduce
      the anxiety of patients with acute coronary syndrome undergoing bed bath. The specific
      objectives included: the development and validation of an informative manual concerning bed
      bath; correlation of physiological variables (systolic and diastolic blood pressure and heart
      and respiratory rate) with the patients' state anxiety; correlation of antecedent variables
      (age, gender, cardiovascular risk factor, use of beta blockers, trait anxiety, depression,
      prior hospitalization, prior experience with bed baths, the patients' preference for a female
      or male professional to perform the bath, pain, fear, and embarrassment) with the patients'
      state anxiety.
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.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: STAI-state
time frame: Participants were followed for the duration of hospital stay, an average of 2 weeks
description: 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.
arm group label: Nursing orientation
arm group type: Experimental
description: Patients who received nursing orientation and read the informative manual concerning bed bath
intervention type: Other
intervention name: Nursing Orientation
description: Control group: patients who did not read the informative manual concerning bed bath and received only the unit's routine information
Intervention group: patients who received nursing orientation and read the informative manual concerning bed bath
arm group label: Nursing orientation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Juliana L Lopes, Ms
role: Principal Investigator
affiliation: Federal University of São Paulo
last name: Alba LB Barros, PhD
role: Study Director
affiliation: Federal University of São Paulo
last name: Luiz A Nogueira-Martins
role: Study Director
affiliation: Federal University of São Paulo
facility: 
country: Brazil
url: http://www.heart.org/HEARTORG/
description: American Heart Association
citation: Lopes Jde L, Nogueira-Martins LA, Goncalves MA, de Barros AL. Comparing levels of anxiety during bed and shower baths in patients with acute myocardial infarction. Rev Lat Am Enfermagem. 2010 Mar-Apr;18(2):217-23. doi: 10.1590/s0104-11692010000200012.
PMID: 20549121
citation: Barsevick A, Llewellyn J. A comparison of the anxiety-reducing potential of two techniques of bathing. Nurs Res. 1982 Jan-Feb;31(1):22-7.
PMID: 6922456
citation: Tel H, Tel H. The effect of individualized education on the transfer anxiety of patients with myocardial infarction and their families. Heart Lung. 2006 Mar-Apr;35(2):101-7. doi: 10.1016/j.hrtlng.2005.09.001.
PMID: 16543038
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Juliana de Lima Lopes
investigator title: Master Degree
mesh term: Acute Coronary Syndrome
mesh term: Syndrome