<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/NCT03791411</url>
  </required_header>
  <id_info>
    <org_study_id>NPR</org_study_id>
    <nct_id>NCT03791411</nct_id>
  </id_info>
  <brief_title>Nursing Narratives, Reflective Practice and Professional Development (NarratUN)</brief_title>
  <acronym>NarratUN</acronym>
  <official_title>Narratives and Reflective Practice: A Programme for the Development of Professional Competences in Nursing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinica Universidad de Navarra, Universidad de Navarra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinica Universidad de Navarra, Universidad de Navarra</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: In addition to foster reflective practice, clinical narratives may be used as a&#xD;
      means to improve nurses' critical thinking and their acquisition of clinical competencies.&#xD;
      However, few studies have studied their potential value to promote nursing professional&#xD;
      development and there is no evidence that shows their value as a tool to improve nurses'&#xD;
      competencies to provide a person-centred nursing care.&#xD;
&#xD;
      Purpose: To evaluate the preliminary efficacy of narratives for the development of three&#xD;
      nursing professional competences -respect, intentional presence and knowing the person-&#xD;
      paramount to provide person-centred care.&#xD;
&#xD;
      Method: A pilot quasi-experimental study. A total of 34 nurses enrolled in a global training&#xD;
      course of a nursing specialization were recruited in September 2016. All the nurses received&#xD;
      a multi-component intervention based on the Critical Reflexive Inquiry Model. The strategies&#xD;
      of this program consisted in the writing of 3 narratives; 3 masterclass of 3, 2 and 3 hours&#xD;
      respectively; a discussion group; and a face-to-face interview. The NarratUN Evaluation tool&#xD;
      was used to assess outcomes. The primary outcome was the difference in the mean of respect,&#xD;
      intentional presence and knowing the person pre and post intervention. Changes within nurses&#xD;
      were analyzed using Wilcoxon signed Rank test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Respect. Measurement tool: NarratUN Evaluation Tool (NET)</measure>
    <time_frame>9 month</time_frame>
    <description>The difference in the mean of respect value (pre-post)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intentional presence. Measurement tool: NarratUN Evaluation Tool (NET)</measure>
    <time_frame>9 month</time_frame>
    <description>The difference in the mean of intentional presence value (pre-post)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knowing the person. Measurement tool: NarratUN Evaluation Tool (NET)</measure>
    <time_frame>9 month</time_frame>
    <description>The difference in the mean of knowing the person value (pre-post)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Handling the narrative. Measurement tool: NarratUN Evaluation Tool (NET)</measure>
    <time_frame>9 month</time_frame>
    <description>The difference in the mean of Handling the narrative value (pre-post)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respect. Measurement tool: NarratUN Evaluation Tool (NET)</measure>
    <time_frame>2 month follow-up</time_frame>
    <description>The difference in the mean of respect value along different times of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intentional presence. Measurement tool: NarratUN Evaluation Tool (NET)</measure>
    <time_frame>2 month follow-up</time_frame>
    <description>The difference in the mean of intentional presence value along different times of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowing the person. Measurement tool: NarratUN Evaluation Tool (NET)</measure>
    <time_frame>2 month follow-up</time_frame>
    <description>The difference in the mean of knowing the person value along different times of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handling the narrative. Measurement tool: NarratUN Evaluation Tool (NET)</measure>
    <time_frame>2 month follow-up</time_frame>
    <description>The difference in the mean of Handling the narrative value along different times of the study</description>
  </secondary_outcome>
  <enrollment type="Actual">69</enrollment>
  <condition>Narrative Medicine</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Nurses enrolled in a global training course of nursing specialization, for the 2016-17,&#xD;
        2017-18, and 2018-19 courses. All students in the specialized training programme will be&#xD;
        included, regardless of age or previous experience.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being in a specialized training programme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not being in a specialized training programme&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ana Choperena Armendáriz</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>December 28, 2018</last_update_submitted>
  <last_update_submitted_qc>December 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clinical Narratives</keyword>
  <keyword>Respect</keyword>
  <keyword>Intentional presence</keyword>
  <keyword>knowing the person</keyword>
  <keyword>Professional development</keyword>
  <!-- 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/NCT03791411
org study id: NPR
nct id: NCT03791411
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: In addition to foster reflective practice, clinical narratives may be used as a
      means to improve nurses' critical thinking and their acquisition of clinical competencies.
      However, few studies have studied their potential value to promote nursing professional
      development and there is no evidence that shows their value as a tool to improve nurses'
      competencies to provide a person-centred nursing care.

      Purpose: To evaluate the preliminary efficacy of narratives for the development of three
      nursing professional competences -respect, intentional presence and knowing the person-
      paramount to provide person-centred care.

      Method: A pilot quasi-experimental study. A total of 34 nurses enrolled in a global training
      course of a nursing specialization were recruited in September 2016. All the nurses received
      a multi-component intervention based on the Critical Reflexive Inquiry Model. The strategies
      of this program consisted in the writing of 3 narratives; 3 masterclass of 3, 2 and 3 hours
      respectively; a discussion group; and a face-to-face interview. The NarratUN Evaluation tool
      was used to assess outcomes. The primary outcome was the difference in the mean of respect,
      intentional presence and knowing the person pre and post intervention. Changes within nurses
      were analyzed using Wilcoxon signed Rank test.
observational model: Other
time perspective: Prospective
measure: Respect. Measurement tool: NarratUN Evaluation Tool (NET)
time frame: 9 month
description: The difference in the mean of respect value (pre-post)
measure: Intentional presence. Measurement tool: NarratUN Evaluation Tool (NET)
time frame: 9 month
description: The difference in the mean of intentional presence value (pre-post)
measure: Knowing the person. Measurement tool: NarratUN Evaluation Tool (NET)
time frame: 9 month
description: The difference in the mean of knowing the person value (pre-post)
measure: Handling the narrative. Measurement tool: NarratUN Evaluation Tool (NET)
time frame: 9 month
description: The difference in the mean of Handling the narrative value (pre-post)
measure: Respect. Measurement tool: NarratUN Evaluation Tool (NET)
time frame: 2 month follow-up
description: The difference in the mean of respect value along different times of the study
measure: Intentional presence. Measurement tool: NarratUN Evaluation Tool (NET)
time frame: 2 month follow-up
description: The difference in the mean of intentional presence value along different times of the study
measure: Knowing the person. Measurement tool: NarratUN Evaluation Tool (NET)
time frame: 2 month follow-up
description: The difference in the mean of knowing the person value along different times of the study
measure: Handling the narrative. Measurement tool: NarratUN Evaluation Tool (NET)
time frame: 2 month follow-up
description: The difference in the mean of Handling the narrative value along different times of the study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Sponsor