<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/NCT02995785</url>
  </required_header>
  <id_info>
    <org_study_id>201611028RINB</org_study_id>
    <nct_id>NCT02995785</nct_id>
  </id_info>
  <brief_title>The First Aid Skill Simulation Training of Nurses of General Wards.</brief_title>
  <official_title>The First Aid Skill Simulation Training of Nurses of General Wards.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      [Background and Objective]First-aid skill training plays an important role in the education&#xD;
      of nurses. How to implement stable and efficient skill is very important. (Kardong-Edgren,&#xD;
      Oermann, Odom-Maryon, &amp; Ha, 2010). Simulation-based workshops,or training, as the most common&#xD;
      enhancing skills.(Topping et al., 2015) .This study was designed to assist nurses enhancing&#xD;
      the clinical ability and safety the patients in the first aid-related skills and knowledge.&#xD;
      The purpose of this study is to compare the two groups of(1) first aid knowledge online test.&#xD;
      (2) first aid skills test.【Methods】This study is a general ward nurses first aid technical&#xD;
      examination, pre-test and post-test, the random control trial. Review by the hospital ethics&#xD;
      committee and execution date on105/12/12-107/03/08, a total of 92 cases, obtained consent of&#xD;
      all cases, then the case will be test in our hospital clinical skills center. Subject&#xD;
      condition: general ward nurse (minimum age&gt; 20 years),exclusion conditions: intensive care&#xD;
      unit nurses, emergency department nurses. Study Procedure: Subjects who obtained the informed&#xD;
      consent were randomly assigned to the first aid skill simulation training group (FAST) or the&#xD;
      traditional group (T) by using a computer generated number. Randomization envelopes were&#xD;
      opened and randomization performed by the study nurse after informed consent was obtained.&#xD;
      Each group consisted of 46 subjects. All the subjects were pre-test first aid knowledge&#xD;
      online test, followed were pre-test first aid skills test at the Clinical Skills Center.After&#xD;
      pre-test,the experimental group are give the first aid skill simulation training with&#xD;
      debriefing(75-min) and online lecture(15-min).While the traditional group only give online&#xD;
      lecture(15-min). Two weeks later, the post-test include online test and skills test for two&#xD;
      groups. After all the data were collected by the researchers who unknown the groups, the&#xD;
      names of the cases were removed and the scores of the two groups were compared before and&#xD;
      after.The test Based on 2015 AHA Guidelines for CPR &amp; ECC (2015 Adult Basic Life Support and&#xD;
      Cardiopulmonary Resuscitation Quality &amp; 2015American Heart Association and 2015).The data&#xD;
      will be archived in SPSS20.0 statistical package software. Statistical methods such as T-test&#xD;
      and Anova variance analysis are used to analyze the data【Expected Result】: The knowledge and&#xD;
      skills in the experimental group were better than the traditional group, and the first-aid&#xD;
      simulation skill training was helpful for the clinical emergency situations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      [Background and Objective]First-aid skill training plays an important role in the education&#xD;
      of nurses. How to implement stable and efficient skill is very important. (Kardong-Edgren,&#xD;
      Oermann, Odom-Maryon, &amp; Ha, 2010). Nursing first aid simulation is very often used to&#xD;
      teaching, the teaching have significant significance of cognitive, skills, satisfaction and&#xD;
      other indicators of achievement (Cant &amp; Cooper, 2010),simulation-based workshops,or training,&#xD;
      as the most common enhancing skills. (Topping et al., 2015) BLS as the basic first aid common&#xD;
      sense and basic knowledge of resuscitation.In our hospital BLS was trained the basic&#xD;
      knowledge and chest compression technique. According to the Department of Nursing first aid&#xD;
      site performance check list found that the first aid equipment used unskilled , 25.5% on&#xD;
      2016/01 to 2016/06.The most unfamiliar techniques and knowledge of 109 nurses(all completed&#xD;
      BLS) were as follows: 33.9% of defibrillator, 25.7% of staff role positions, 20.7% of first&#xD;
      aid medications, and 14.7% of intubation device and LMA (Laryngeal Mask Airway ) on&#xD;
      105/10/1-105/10/17.This study was designed to assist nurses enhancing the clinical ability&#xD;
      and safety the patients in the first aid-related skills and knowledge. The purpose of this&#xD;
      study is to compare the two groups of(1) first aid knowledge online test. (2) first aid&#xD;
      skills test.【Methods】This study is a general ward nurses first aid technical examination,&#xD;
      pre-test and post-test, the random control trial. Review by the hospital ethics committee and&#xD;
      execution date on105/12/12-107/03/08, a total of 92 cases, obtained consent of all cases,&#xD;
      then the case will be test in our hospital clinical skills center. Subject condition: general&#xD;
      ward nurse (minimum age&gt; 20 years),exclusion conditions: intensive care unit nurses,&#xD;
      emergency department nurses. Study Procedure: Subjects who obtained the informed consent were&#xD;
      randomly assigned to the first aid skill simulation training group (FAST) or the traditional&#xD;
      group (T) by using a computer generated number. Randomization envelopes were opened and&#xD;
      randomization performed by the study nurse after informed consent was obtained. Each group&#xD;
      consisted of 46 subjects. All the subjects were pre-test first aid knowledge online test,&#xD;
      followed were pre-test first aid skills test at the Clinical Skills Center by eight&#xD;
      instructors who were more than 20 years worked experience. After pre-test, the experimental&#xD;
      group are give the first aid skill simulation training guidance on-site with discussion and&#xD;
      debriefing(75-min) and TMS online lecture(15-min).While the traditional group only give TMS&#xD;
      online lecture(15-min). Two weeks later, the post-test include first aid knowledge online&#xD;
      test and first aid skills test for two groups. After all the data were collected by the&#xD;
      researchers who unknown the groups, the names of the cases were removed and the scores of the&#xD;
      two groups were compared before and after about(1) first aid knowledge online test. (2) first&#xD;
      aid skills test. The test Based on 2015 AHA Guidelines for CPR &amp; ECC (2015 Adult Basic Life&#xD;
      Support and Cardiopulmonary Resuscitation Quality &amp; 2015American Heart Association and&#xD;
      2015).First Station: Equipment testing, Second Station: Assisted with intubation and&#xD;
      fixation, Third Station: LMA, Fourth Station: Ambu bagging, Fifth Station: Drugs, Sixth&#xD;
      Station: Defribrator, Seventh Station: Role positioning, and Eighth Station: Leader Training.&#xD;
      The data will be archived in SPSS20.0 statistical package software. Statistical methods such&#xD;
      as T-test and Anova variance analysis are used to analyze the data【Expected Result】: The&#xD;
      knowledge and skills in the experimental group were better than the traditional group, and&#xD;
      the first-aid simulation skill training was helpful for the clinical emergency situations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in First aid skills test at 2 Weeks.</measure>
    <time_frame>baseline and 2 weeks.</time_frame>
    <description>The test Based on 2015 AHA Guidelines for CPR &amp; ECC (2015 Adult Basic Life Support and Cardiopulmonary Resuscitation Quality &amp; 2015American Heart Association and 2015).The contents of the test,first station:equipment test 13%, second station:assisted with intubation and fixation 16%, third station: LMA 12%, fourth station: Ambu bagging 10%, fifth station: Drugs 12%, sixth station: Defribrator 12%, seventh station: Role positioning 17%, and eighth station: Leader Training 8%, total score is 100 points, the higher the better.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in First aid knowledge online test at 2 Weeks.</measure>
    <time_frame>baseline and 2 weeks.</time_frame>
    <description>The test Based on 2015 AHA Guidelines for CPR &amp; ECC (2015 Adult Basic Life Support and Cardiopulmonary Resuscitation Quality &amp; 2015American Heart Association and 2015). The contents of the test, 20 questions from 40 questions of random, each question 5 points, total score is 100 points, the higher the better.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">92</enrollment>
  <condition>Simulation</condition>
  <arm_group>
    <arm_group_label>Experimental:simulation-based training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Experimental</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active comparatorr: traditional training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Traditional</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>simulation-based training</intervention_name>
    <description>simulation-based training:The first aid skill simulation training with discussion and debriefing(75-min) and TMS online lecture(15-min).</description>
    <arm_group_label>Experimental:simulation-based training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>traditional training</intervention_name>
    <description>traditional training:Give TMS online lecture(15-min).</description>
    <arm_group_label>Active comparatorr: traditional training</arm_group_label>
    <arm_group_label>Experimental:simulation-based training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  general ward nurse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  intensive care unit nurses, emergency department nurses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Shing chen</last_name>
    <role>Study Chair</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pei-Yin Hsieh, MSN</last_name>
    <phone>+886-2-23123456</phone>
    <phone_ext>63501</phone_ext>
    <email>peiyin3111@ntuh.gov.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jin-Shing chen</last_name>
    <email>chenjs@ntu.edu.tw</email>
  </overall_contact_backup>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Simulation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02995785
org study id: 201611028RINB
nct id: NCT02995785
lead sponsor: 
has dmc: No
[Background and Objective]First-aid skill training plays an important role in the education
      of nurses. How to implement stable and efficient skill is very important. (Kardong-Edgren,
      Oermann, Odom-Maryon, & Ha, 2010). Simulation-based workshops,or training, as the most common
      enhancing skills.(Topping et al., 2015) .This study was designed to assist nurses enhancing
      the clinical ability and safety the patients in the first aid-related skills and knowledge.
      The purpose of this study is to compare the two groups of(1) first aid knowledge online test.
      (2) first aid skills test.【Methods】This study is a general ward nurses first aid technical
      examination, pre-test and post-test, the random control trial. Review by the hospital ethics
      committee and execution date on105/12/12-107/03/08, a total of 92 cases, obtained consent of
      all cases, then the case will be test in our hospital clinical skills center. Subject
      condition: general ward nurse (minimum age> 20 years),exclusion conditions: intensive care
      unit nurses, emergency department nurses. Study Procedure: Subjects who obtained the informed
      consent were randomly assigned to the first aid skill simulation training group (FAST) or the
      traditional group (T) by using a computer generated number. Randomization envelopes were
      opened and randomization performed by the study nurse after informed consent was obtained.
      Each group consisted of 46 subjects. All the subjects were pre-test first aid knowledge
      online test, followed were pre-test first aid skills test at the Clinical Skills Center.After
      pre-test,the experimental group are give the first aid skill simulation training with
      debriefing(75-min) and online lecture(15-min).While the traditional group only give online
      lecture(15-min). Two weeks later, the post-test include online test and skills test for two
      groups. After all the data were collected by the researchers who unknown the groups, the
      names of the cases were removed and the scores of the two groups were compared before and
      after.The test Based on 2015 AHA Guidelines for CPR & ECC (2015 Adult Basic Life Support and
      Cardiopulmonary Resuscitation Quality & 2015American Heart Association and 2015).The data
      will be archived in SPSS20.0 statistical package software. Statistical methods such as T-test
      and Anova variance analysis are used to analyze the data【Expected Result】: The knowledge and
      skills in the experimental group were better than the traditional group, and the first-aid
      simulation skill training was helpful for the clinical emergency situations.
[Background and Objective]First-aid skill training plays an important role in the education
      of nurses. How to implement stable and efficient skill is very important. (Kardong-Edgren,
      Oermann, Odom-Maryon, & Ha, 2010). Nursing first aid simulation is very often used to
      teaching, the teaching have significant significance of cognitive, skills, satisfaction and
      other indicators of achievement (Cant & Cooper, 2010),simulation-based workshops,or training,
      as the most common enhancing skills. (Topping et al., 2015) BLS as the basic first aid common
      sense and basic knowledge of resuscitation.In our hospital BLS was trained the basic
      knowledge and chest compression technique. According to the Department of Nursing first aid
      site performance check list found that the first aid equipment used unskilled , 25.5% on
      2016/01 to 2016/06.The most unfamiliar techniques and knowledge of 109 nurses(all completed
      BLS) were as follows: 33.9% of defibrillator, 25.7% of staff role positions, 20.7% of first
      aid medications, and 14.7% of intubation device and LMA (Laryngeal Mask Airway ) on
      105/10/1-105/10/17.This study was designed to assist nurses enhancing the clinical ability
      and safety the patients in the first aid-related skills and knowledge. The purpose of this
      study is to compare the two groups of(1) first aid knowledge online test. (2) first aid
      skills test.【Methods】This study is a general ward nurses first aid technical examination,
      pre-test and post-test, the random control trial. Review by the hospital ethics committee and
      execution date on105/12/12-107/03/08, a total of 92 cases, obtained consent of all cases,
      then the case will be test in our hospital clinical skills center. Subject condition: general
      ward nurse (minimum age> 20 years),exclusion conditions: intensive care unit nurses,
      emergency department nurses. Study Procedure: Subjects who obtained the informed consent were
      randomly assigned to the first aid skill simulation training group (FAST) or the traditional
      group (T) by using a computer generated number. Randomization envelopes were opened and
      randomization performed by the study nurse after informed consent was obtained. Each group
      consisted of 46 subjects. All the subjects were pre-test first aid knowledge online test,
      followed were pre-test first aid skills test at the Clinical Skills Center by eight
      instructors who were more than 20 years worked experience. After pre-test, the experimental
      group are give the first aid skill simulation training guidance on-site with discussion and
      debriefing(75-min) and TMS online lecture(15-min).While the traditional group only give TMS
      online lecture(15-min). Two weeks later, the post-test include first aid knowledge online
      test and first aid skills test for two groups. After all the data were collected by the
      researchers who unknown the groups, the names of the cases were removed and the scores of the
      two groups were compared before and after about(1) first aid knowledge online test. (2) first
      aid skills test. The test Based on 2015 AHA Guidelines for CPR & ECC (2015 Adult Basic Life
      Support and Cardiopulmonary Resuscitation Quality & 2015American Heart Association and
      2015).First Station: Equipment testing, Second Station: Assisted with intubation and
      fixation, Third Station: LMA, Fourth Station: Ambu bagging, Fifth Station: Drugs, Sixth
      Station: Defribrator, Seventh Station: Role positioning, and Eighth Station: Leader Training.
      The data will be archived in SPSS20.0 statistical package software. Statistical methods such
      as T-test and Anova variance analysis are used to analyze the data【Expected Result】: The
      knowledge and skills in the experimental group were better than the traditional group, and
      the first-aid simulation skill training was helpful for the clinical emergency situations.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Investigator)
measure: Change from Baseline in First aid skills test at 2 Weeks.
time frame: baseline and 2 weeks.
description: The test Based on 2015 AHA Guidelines for CPR & ECC (2015 Adult Basic Life Support and Cardiopulmonary Resuscitation Quality & 2015American Heart Association and 2015).The contents of the test,first station:equipment test 13%, second station:assisted with intubation and fixation 16%, third station: LMA 12%, fourth station: Ambu bagging 10%, fifth station: Drugs 12%, sixth station: Defribrator 12%, seventh station: Role positioning 17%, and eighth station: Leader Training 8%, total score is 100 points, the higher the better.
measure: Change from Baseline in First aid knowledge online test at 2 Weeks.
time frame: baseline and 2 weeks.
description: The test Based on 2015 AHA Guidelines for CPR & ECC (2015 Adult Basic Life Support and Cardiopulmonary Resuscitation Quality & 2015American Heart Association and 2015). The contents of the test, 20 questions from 40 questions of random, each question 5 points, total score is 100 points, the higher the better.
arm group label: Experimental:simulation-based training
arm group type: Other
description: Experimental
arm group label: Active comparatorr: traditional training
arm group type: Other
description: Traditional
intervention type: Other
intervention name: simulation-based training
description: simulation-based training:The first aid skill simulation training with discussion and debriefing(75-min) and TMS online lecture(15-min).
arm group label: Experimental:simulation-based training
intervention type: Other
intervention name: traditional training
description: traditional training:Give TMS online lecture(15-min).
arm group label: Active comparatorr: traditional training
arm group label: Experimental:simulation-based training
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jin-Shing chen
role: Study Chair
affiliation: National Taiwan University Hospital
last name: Pei-Yin Hsieh, MSN
phone: +886-2-23123456
phone ext: 63501
email: peiyin3111@ntuh.gov.tw
last name: Jin-Shing chen
email: chenjs@ntu.edu.tw
responsible party type: Sponsor
sharing ipd: No