<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/NCT02245984</url>
  </required_header>
  <id_info>
    <org_study_id>922488</org_study_id>
    <secondary_id>123456</secondary_id>
    <nct_id>NCT02245984</nct_id>
  </id_info>
  <brief_title>Effect of Applying Paper- Based Versus Electronic Nursing Process on Clinical Competence of Nursing Student</brief_title>
  <acronym>NP</acronym>
  <official_title>Comparison Effect of Applying Paper- Based Versus Electronic Nursing Process on Clinical Competence of Undergraduate Nursing Students' of Mashhad Nursing and Midwifery School</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mashhad University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mashhad University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare the clinical competence of undergraduate nursing students' of mashhad nursing and&#xD;
      midwifery school in two groups applying nursing process (paper- based versus electronic).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The sample consisted of at least 30 nursing students in each of the groups A (paper-based&#xD;
      nursing process or PNP) and B (Electronic nursing process or ENP) based on random allocation&#xD;
      (lottery sectors) will be divided into two groups. The level of knowledge about nursing&#xD;
      process, clinical competency and clinical decision making will evaluate by the knowledge of&#xD;
      nursing process, Meretoja competence modified and Lauri clinical decision making&#xD;
      questionnaires, by the investigator. Then, for each of the groups separately-training program&#xD;
      aimed to education the nursing process and how to do it (including the definition of the&#xD;
      nursing process, advantages and its implementation and how to collect data using patient&#xD;
      assessment forms Gordon) in the form of workshops a day (5 hours) will be implemented.&#xD;
      Nursing process education in the two groups will similar but two hours of the program in each&#xD;
      groups is devoted to practical training on how to implement. After completing the training&#xD;
      program, students learn about the nursing process will be determined in the same way. Then&#xD;
      for two weeks, students in Group A and Group B will be implemented paper and electronic&#xD;
      nursing process for patients and researchers will perform under your guidance will be closely&#xD;
      monitored. Clinical competence and clinical decision making will be assessed again at the end&#xD;
      of the course with previous method. Satisfaction of the nursing process in each group will be&#xD;
      measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">September 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical competency</measure>
    <time_frame>2 months</time_frame>
    <description>clinical competency will be measured with modified nursing competence scale(NCS)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Competence</condition>
  <arm_group>
    <arm_group_label>paper based nursing process</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>for two weeks, students in paper based nursing group will be implemented paper nursing process for patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>electronic nursing process</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>for two weeks students in this group will be implemented electronic nursing process for patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>paper based nursing process</intervention_name>
    <description>for two weeks, students in paper based nursing group will be implemented paper nursing process for patients.</description>
    <arm_group_label>paper based nursing process</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>electronic nursing process</intervention_name>
    <description>for each of the groups separately-training program aimed to education the nursing process and how to do it (including the definition of the nursing process, advantages and its implementation and how to collect data using patient assessment forms Gordon) in the form of workshops a day (5 hours) will be implemented. Nursing process education in the two groups will similar but two hours of the program in each groups is devoted to practical training on how to implement. After completing the training program, students learn about the nursing process will be determined in the same way. Then for two weeks, students in Group A and Group B will be implemented paper and electronic nursing process for patients.</description>
    <arm_group_label>electronic nursing process</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness to participate in the study&#xD;
&#xD;
          -  No Experience working independently (student work, employment, etc.) as a Nurse.&#xD;
&#xD;
          -  Participate in the first day of the internship program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to complete course training&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>s reza mazloum, phd</last_name>
    <role>Study Director</role>
    <affiliation>MUMS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>mohammad rajabpoor, MS student</last_name>
    <phone>09158341840</phone>
    <email>rajabpoorm921@mums.ac.ir</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ghaem hospital</name>
      <address>
        <city>Mashhad</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>mohammad rajabpoor, student</last_name>
      <phone>09158341840</phone>
      <email>rajabpoorm871@gmail.com</email>
    </contact>
    <investigator>
      <last_name>seyed reza mazlom, phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>mohmmad rajabpoor, Msc Student</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <link>
    <url>http://www.mums.ac.ir</url>
    <description>Mashhad University Medical of Sciences</description>
  </link>
  <results_reference>
    <citation>Meretoja R, Leino-Kilpi H, Kaira AM. Comparison of nurse competence in different hospital work environments. J Nurs Manag. 2004 Sep;12(5):329-36. doi: 10.1111/j.1365-2834.2004.00422.x.</citation>
    <PMID>15315489</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>September 20, 2014</last_update_submitted>
  <last_update_submitted_qc>September 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mashhad University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Seyedreza Mazloum</investigator_full_name>
    <investigator_title>Mashhad University of Medical Sciences</investigator_title>
  </responsible_party>
  <keyword>clinical competence, nursing process, nursing student</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/NCT02245984
org study id: 922488
secondary id: 123456
nct id: NCT02245984
lead sponsor: 
has dmc: Yes
Compare the clinical competence of undergraduate nursing students' of mashhad nursing and
      midwifery school in two groups applying nursing process (paper- based versus electronic).
The sample consisted of at least 30 nursing students in each of the groups A (paper-based
      nursing process or PNP) and B (Electronic nursing process or ENP) based on random allocation
      (lottery sectors) will be divided into two groups. The level of knowledge about nursing
      process, clinical competency and clinical decision making will evaluate by the knowledge of
      nursing process, Meretoja competence modified and Lauri clinical decision making
      questionnaires, by the investigator. Then, for each of the groups separately-training program
      aimed to education the nursing process and how to do it (including the definition of the
      nursing process, advantages and its implementation and how to collect data using patient
      assessment forms Gordon) in the form of workshops a day (5 hours) will be implemented.
      Nursing process education in the two groups will similar but two hours of the program in each
      groups is devoted to practical training on how to implement. After completing the training
      program, students learn about the nursing process will be determined in the same way. Then
      for two weeks, students in Group A and Group B will be implemented paper and electronic
      nursing process for patients and researchers will perform under your guidance will be closely
      monitored. Clinical competence and clinical decision making will be assessed again at the end
      of the course with previous method. Satisfaction of the nursing process in each group will be
      measured.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: clinical competency
time frame: 2 months
description: clinical competency will be measured with modified nursing competence scale(NCS)
arm group label: paper based nursing process
arm group type: Experimental
description: for two weeks, students in paper based nursing group will be implemented paper nursing process for patients.
arm group label: electronic nursing process
arm group type: Experimental
description: for two weeks students in this group will be implemented electronic nursing process for patients.
intervention type: Other
intervention name: paper based nursing process
description: for two weeks, students in paper based nursing group will be implemented paper nursing process for patients.
arm group label: paper based nursing process
intervention type: Other
intervention name: electronic nursing process
description: for each of the groups separately-training program aimed to education the nursing process and how to do it (including the definition of the nursing process, advantages and its implementation and how to collect data using patient assessment forms Gordon) in the form of workshops a day (5 hours) will be implemented. Nursing process education in the two groups will similar but two hours of the program in each groups is devoted to practical training on how to implement. After completing the training program, students learn about the nursing process will be determined in the same way. Then for two weeks, students in Group A and Group B will be implemented paper and electronic nursing process for patients.
arm group label: electronic nursing process
criteria: 
gender: All
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: s reza mazloum, phd
role: Study Director
affiliation: MUMS
last name: mohammad rajabpoor, MS student
phone: 09158341840
email: rajabpoorm921@mums.ac.ir
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Iran, Islamic Republic of
url: http://www.mums.ac.ir
description: Mashhad University Medical of Sciences
citation: Meretoja R, Leino-Kilpi H, Kaira AM. Comparison of nurse competence in different hospital work environments. J Nurs Manag. 2004 Sep;12(5):329-36. doi: 10.1111/j.1365-2834.2004.00422.x.
PMID: 15315489
responsible party type: Principal Investigator
investigator affiliation: Mashhad University of Medical Sciences
investigator full name: Seyedreza Mazloum
investigator title: Mashhad University of Medical Sciences