<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/NCT04482023</url>
  </required_header>
  <id_info>
    <org_study_id>2020663</org_study_id>
    <nct_id>NCT04482023</nct_id>
  </id_info>
  <brief_title>Emotional Support and Stress Management in Patients Diagnosed With COVID-19</brief_title>
  <acronym>WWCOVID-19</acronym>
  <official_title>Emotional Support and Stress Management Activities Offered by Nurses to Patients Diagnosed With COVID-19 During Hospital Admission</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corporacion Parc Tauli</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to identify the knowledge that CCSPT nurses have in relation to care&#xD;
      aimed at addressing anxiety, fear or loneliness and the use they have made of it in the&#xD;
      recent crisis. The design of the research/action will also enable the training of the&#xD;
      participating professionals to improve nursing care in these areas in the future&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cross-sectional descriptive study with a research/action design to be carried out&#xD;
      at the Consorci Corporació Sanitària Parc Taulí (CCSPT). The aim of this study is to identify&#xD;
      the knowledge that CCSPT nurses have in relation to care aimed at coping with anxiety, fear&#xD;
      or loneliness and the use that they have made of it in the recent crisis. By its design, the&#xD;
      research/action will allow the training of these nurses to improve nursing care of these&#xD;
      aspects in the future. This is a population-based study, in which all CCSPT nurses who have&#xD;
      carried out care work during the COVID-19 crisis period will be invited to participate. The&#xD;
      variables collected will be age, sex, academic level, usual work shift, care given to reduce&#xD;
      anxiety, fear, loneliness, coping style and self-pity. Quantitative variables will be&#xD;
      described by their mean and standard deviation, while qualitative variables will be described&#xD;
      in absolute and relative frequencies. A linear or non-parametric correlation will be made&#xD;
      between the score on the self-pity and coping scales and the number of actions identified&#xD;
      and/or performed referred to by the nurses and the calculation of the Pearson or Spearman&#xD;
      correlation coefficient, as appropriate. Comparison of the number of actions between high&#xD;
      activity and low activity (70% cut) coping nurses using the Mann-Whitney U test&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 23, 2021</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of care actions identified by nurses</measure>
    <time_frame>6 months after care</time_frame>
    <description>% of care actions identified by nurses</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of care actions taken by nurses</measure>
    <time_frame>6 months after care</time_frame>
    <description>% of care actions taken by nurses</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Nurses COVID 19</arm_group_label>
    <description>Nurses from any unit of the Consortium Parc Taulí Corporation who have been in direct care of patients diagnosed with COVID 19 between March 9, 2020 and May 15, 2020</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Training video on anxiety, fear and loneliness in the COVID-19 environment.</intervention_name>
    <description>Video with the actions identified as essential to address the diagnosis of anxiety, fear and loneliness in the environment COVID-19 identified by a group of experts.</description>
    <arm_group_label>Nurses COVID 19</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        CCSPT nurses&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nurses from any unit of the Consortium Parc Taulí Corporation who have been in direct&#xD;
             care of patients diagnosed with COVID 19 between March 9, 2020 and May 15, 2020&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Montserrat Montaña, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Corporación Parc Taulí</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Montserrat Montaña, PhD</last_name>
    <phone>+34692617376</phone>
    <email>mmontana@tauli.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jordi Torralbas, MSc</last_name>
    <phone>+34937231010</phone>
    <email>jtorralbas@tauli.cat</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Montserrat Montaña</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Montserrat Montaña, PhD</last_name>
      <phone>+34692617376</phone>
      <email>mmontana@tauli.cat</email>
    </contact>
    <contact_backup>
      <last_name>Jordi Torralbas, MSc</last_name>
      <phone>+34937231010</phone>
      <email>jtorralbas@tauli.cat</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>March 23, 2021</last_update_submitted>
  <last_update_submitted_qc>March 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
    <investigator_full_name>Montserrat Montaña</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Research</investigator_title>
  </responsible_party>
  <keyword>Nursing care</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Loneliness</keyword>
  <keyword>Fear</keyword>
  <keyword>Education</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04482023
org study id: 2020663
nct id: NCT04482023
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to identify the knowledge that CCSPT nurses have in relation to care
      aimed at addressing anxiety, fear or loneliness and the use they have made of it in the
      recent crisis. The design of the research/action will also enable the training of the
      participating professionals to improve nursing care in these areas in the future
This is a cross-sectional descriptive study with a research/action design to be carried out
      at the Consorci Corporació Sanitària Parc Taulí (CCSPT). The aim of this study is to identify
      the knowledge that CCSPT nurses have in relation to care aimed at coping with anxiety, fear
      or loneliness and the use that they have made of it in the recent crisis. By its design, the
      research/action will allow the training of these nurses to improve nursing care of these
      aspects in the future. This is a population-based study, in which all CCSPT nurses who have
      carried out care work during the COVID-19 crisis period will be invited to participate. The
      variables collected will be age, sex, academic level, usual work shift, care given to reduce
      anxiety, fear, loneliness, coping style and self-pity. Quantitative variables will be
      described by their mean and standard deviation, while qualitative variables will be described
      in absolute and relative frequencies. A linear or non-parametric correlation will be made
      between the score on the self-pity and coping scales and the number of actions identified
      and/or performed referred to by the nurses and the calculation of the Pearson or Spearman
      correlation coefficient, as appropriate. Comparison of the number of actions between high
      activity and low activity (70% cut) coping nurses using the Mann-Whitney U test
observational model: Case-Only
time perspective: Cross-Sectional
measure: Rate of care actions identified by nurses
time frame: 6 months after care
description: % of care actions identified by nurses
measure: Rate of care actions taken by nurses
time frame: 6 months after care
description: % of care actions taken by nurses
arm group label: Nurses COVID 19
description: Nurses from any unit of the Consortium Parc Taulí Corporation who have been in direct care of patients diagnosed with COVID 19 between March 9, 2020 and May 15, 2020
intervention type: Behavioral
intervention name: Training video on anxiety, fear and loneliness in the COVID-19 environment.
description: Video with the actions identified as essential to address the diagnosis of anxiety, fear and loneliness in the environment COVID-19 identified by a group of experts.
arm group label: Nurses COVID 19
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Montserrat Montaña, PhD
role: Principal Investigator
affiliation: Corporación Parc Taulí
last name: Montserrat Montaña, PhD
phone: +34692617376
email: mmontana@tauli.cat
last name: Jordi Torralbas, MSc
phone: +34937231010
email: jtorralbas@tauli.cat
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Corporacion Parc Tauli
investigator full name: Montserrat Montaña
investigator title: Principal Investigator, Clinical Research
mesh term: COVID-19