<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/NCT02993393</url>
  </required_header>
  <id_info>
    <org_study_id>369/2558(EC3)</org_study_id>
    <nct_id>NCT02993393</nct_id>
  </id_info>
  <brief_title>A Comparative Study Between Simulation-based and Problem-based Learning in Difficult Airway Management Workshop</brief_title>
  <official_title>Faculty of Medicine Siriraj Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Siriraj Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Siriraj Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abstract Background and Goal of study Teaching and learning in airway management are&#xD;
      essential in anesthetic field. Though simulation-based and problem-based learning are&#xD;
      sophisticated learning tool, neither of them manifests the superior benefit. We would like to&#xD;
      compare the teachers' and students' attitudes on these two learning methods.&#xD;
&#xD;
      Material and Methods After IRB approval No. 369/2558(EC3). A prospective,&#xD;
      questionnaires-based study was performed amongst volunteered, consent-signed, 10&#xD;
      anesthesiologists and 40 nurse anesthetist students. After stratified randomization, ten&#xD;
      students simultaneously attended either SBL or PBL course one at a time. Six weeks later, a&#xD;
      crossover technique was applied for both groups. At the end of project, teachers and students&#xD;
      had to response to Likert's scale questionnaires.&#xD;
&#xD;
      The teachers' questionnaire based on table of specification of the learning contents,&#xD;
      consisted of 4 parts: airway evaluation, patient preparation, strategic planning and follow&#xD;
      up care. The students' questionnaire comprised 3 parts: learning content, process and&#xD;
      evaluation.&#xD;
&#xD;
      The validation of the questionnaire was determined by three board-certified&#xD;
      anesthesiologists. The index of item objective congruence was 0.80 and 0.82 with Cronbach's&#xD;
      Alpha of 0.97 and 0.92 respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction Currently, teachers have emphasized the instructional strategies and enthusiasm&#xD;
      in critical thinking to students to understand the educational course1. As coaching mentors,&#xD;
      they search for innovative teaching models to reach the learning target 2. In anesthesia, a&#xD;
      training program of nurse students involves several teaching methods such as seminars,&#xD;
      journal clubs as well as topic, didactic, simulation and problem-based learning 13, 14.&#xD;
&#xD;
      Simulation-based learning in medicine utilizes aides such as manikins or actors to replicate&#xD;
      clinical scenarios. It yields the acquisition of skills through deliberate practice rather&#xD;
      than an apprentice style of learning 22. However, problem-based learning is a small group&#xD;
      discussions where students are active, learner-centered, or self-directed learning to the&#xD;
      topic assignments. Teachers play role as moderators or facilitators 21.&#xD;
&#xD;
      Teaching and learning in airway management are essential in anesthetic field. The personnel&#xD;
      need to be keen both basic and advance knowledge owing to its applications to the benefits of&#xD;
      patients' life. At present, the diversity of learning techniques (PBL and SBL) allows&#xD;
      sophisticated devices as an interactive learning tool to cope with all difficulties in&#xD;
      details.&#xD;
&#xD;
      Nevertheless, neither PBL nor SBL manifests the superior benefit of instructional process and&#xD;
      learning content xx. Chin KL, et al. (2014) concluded that simulation was superior to&#xD;
      case-based learning in teaching diabetic ketoacidosis and thyroid storm to the final-year,&#xD;
      undergraduate pharmacy students. Randolph H, et al. (2006) revealed that students who learned&#xD;
      critical assessment and management skills using full-scale, high- fidelity simulation,&#xD;
      performed better than students who acquired similar skills in an interactive problem-based&#xD;
      learning format.&#xD;
&#xD;
      As either PBL or SBL on difficult airway management is based upon the same table of&#xD;
      specifications and experienced instructors. We would like to compare the teachers' and&#xD;
      students' attitudes on these two learning methods.&#xD;
&#xD;
      Objectives To compare between PBL and SBL in terms of learning content, instructional and&#xD;
      evaluation methods&#xD;
&#xD;
      Material and Methods After IRB approval No. 369/2558(EC3). A prospective,&#xD;
      questionnaires-based study was performed amongst 40 volunteered, consent-signed nurse&#xD;
      anesthetist students. The inclusion criteria for teachers were anesthesiologists who have&#xD;
      involved in SBL and PBL with more than 3 years of experience in teaching. The inclusion&#xD;
      criteria for students were nurse anesthetist students in the academic years of 2015. The&#xD;
      exclusion criteria of both groups were ones who did not fit all qualifications.&#xD;
&#xD;
      After stratified randomization, ten nurse anesthetist students attended either SBL or PBL&#xD;
      course one at a time. The one-day workshops were performed simultaneously. Six weeks later, a&#xD;
      crossover technique was applied for both groups. At the end of project, teachers and students&#xD;
      had to response to Likert's scale questionnaires: 4 = very suitable, 3 = suitable, 2 =&#xD;
      unsuitable, 1 = very unsuitable.&#xD;
&#xD;
      The teachers' questionnaire based on table of specification of the learning contents,&#xD;
      consisted of 4 parts: airway evaluation (history taking and physical examination), patient&#xD;
      preparation (equipments and experienced helpers), 5 strategic planning (facemask ventilation,&#xD;
      supraglottic airway device, laryngoscopy, tracheal intubation and failed intubation) and&#xD;
      follow up care (documentation and informative advice).&#xD;
&#xD;
      On the other hand, the students' questionnaires comprised 3 parts: learning content, process&#xD;
      and evaluation.&#xD;
&#xD;
      The correctness and appropriateness of the questionnaires (content validity) were determined&#xD;
      by three board-certified anesthesiologists who had at least ten year experiences in&#xD;
      anesthesia and were not involved in the project. The tryout was performed by ten novice nurse&#xD;
      anesthetists and five anesthesiologists on students' and teachers' matters respectively. The&#xD;
      index of item objective congruence was 0.80 and 0.82 with Cronbach's Alpha of 0.97 and 0.92&#xD;
      respectively. We used percentage, mean, standard deviation and student t-Test for data&#xD;
      analysis at the significant level of 0.05 with 95% confident interval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2015</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Student's point of view</measure>
    <time_frame>1 year</time_frame>
    <description>Likert's scale questionnaires 4 = very suitable, 3 = suitable, 2 = unsuitable, 1 = very unsuitable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Teacher's point of view</measure>
    <time_frame>1 year</time_frame>
    <description>Likert's scale questionnaires 4 = very suitable, 3 = suitable, 2 = unsuitable, 1 = very unsuitable.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Education</condition>
  <arm_group>
    <arm_group_label>Teachers</arm_group_label>
    <description>Anesthesiologists who have involved in SBL and PBL with more than 3 years of experience in teaching</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Students</arm_group_label>
    <description>Students were nurse anesthetist students in the academic years of 2015</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Teacher</intervention_name>
    <description>The teachers' questionnaire based on table of specification of the learning contents, consisted of 4 parts: airway evaluation, patient preparation, strategic planning and follow up care.</description>
    <arm_group_label>Teachers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Student</intervention_name>
    <description>The students' questionnaire comprised 3 parts: learning content, process and evaluation.</description>
    <arm_group_label>Students</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        anesthesiologists who have involved in SBL and PBL with more than 3 years of experience in&#xD;
        teaching.&#xD;
&#xD;
        nurse anesthetist students&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  anesthesiologists who have involved in SBL and PBL with more than 3 years of&#xD;
             experience in teaching.&#xD;
&#xD;
          -  nurse anesthetist students in the academic years of 2015.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ones who did not fit all qualifications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mrs.Parichad Apidechakul, MPA. B.Ns.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology, Faculty of Medicine, Siriraj hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mrs.Parichad Apidechakul, MPA. B.Ns.</last_name>
    <phone>897942082</phone>
    <email>dao_pari@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Phongthara Vichitvejpaisal, MD.PhD.</last_name>
    <phone>818384393</phone>
    <email>phongthara@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Parichad Apidechakul</name>
      <address>
        <city>Nonthaburi</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Parichad Apidechakul, B.Ns.M.P. A.</last_name>
      <phone>+66897942082</phone>
      <email>dao_pari@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Phongthara Vijitvejpaisal, M.D.Ph.D.</last_name>
      <phone>+66818384393</phone>
      <email>phongthara@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <results_reference>
    <citation>Reilly A, Spratt C. The perceptions of undergraduate student nurses of high-fidelity simulation-based learning: a case report from the University of Tasmania. Nurse Educ Today. 2007 Aug;27(6):542-50. doi: 10.1016/j.nedt.2006.08.015. Epub 2006 Oct 25.</citation>
    <PMID>17069935</PMID>
  </results_reference>
  <results_reference>
    <citation>Rowan CJ, McCourt C, Beake S. Problem based learning in midwifery--the students' perspective. Nurse Educ Today. 2008 Jan;28(1):93-9. doi: 10.1016/j.nedt.2007.02.014. Epub 2007 May 11.</citation>
    <PMID>17499395</PMID>
  </results_reference>
  <results_reference>
    <citation>Lorello GR, Cook DA, Johnson RL, Brydges R. Simulation-based training in anaesthesiology: a systematic review and meta-analysis. Br J Anaesth. 2014 Feb;112(2):231-45. doi: 10.1093/bja/aet414. Epub 2013 Dec 23.</citation>
    <PMID>24368556</PMID>
  </results_reference>
  <results_reference>
    <citation>Chilkoti G, Mohta M, Wadhwa R, Saxena AK. Problem-based learning research in anesthesia teaching: current status and future perspective. Anesthesiol Res Pract. 2014;2014:263948. doi: 10.1155/2014/263948. Epub 2014 May 29.</citation>
    <PMID>24982673</PMID>
  </results_reference>
  <results_reference>
    <citation>Al-Elq AH. Simulation-based medical teaching and learning. J Family Community Med. 2010 Jan;17(1):35-40. doi: 10.4103/1319-1683.68787.</citation>
    <PMID>22022669</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Siriraj Hospital</investigator_affiliation>
    <investigator_full_name>Mrs.Parichad Apidechakul</investigator_full_name>
    <investigator_title>Nurse anesthetist</investigator_title>
  </responsible_party>
  <keyword>Simulation Training [I02.903.847]</keyword>
  <keyword>Problem-Based Learning [F02.463.425.720]</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 5, 2017</submitted>
    <returned>April 14, 2017</returned>
    <submitted>April 24, 2017</submitted>
    <returned>August 3, 2017</returned>
  </pending_results>
  <!-- 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/NCT02993393
org study id: 369/2558(EC3)
nct id: NCT02993393
lead sponsor: 
has dmc: Yes
Abstract Background and Goal of study Teaching and learning in airway management are
      essential in anesthetic field. Though simulation-based and problem-based learning are
      sophisticated learning tool, neither of them manifests the superior benefit. We would like to
      compare the teachers' and students' attitudes on these two learning methods.

      Material and Methods After IRB approval No. 369/2558(EC3). A prospective,
      questionnaires-based study was performed amongst volunteered, consent-signed, 10
      anesthesiologists and 40 nurse anesthetist students. After stratified randomization, ten
      students simultaneously attended either SBL or PBL course one at a time. Six weeks later, a
      crossover technique was applied for both groups. At the end of project, teachers and students
      had to response to Likert's scale questionnaires.

      The teachers' questionnaire based on table of specification of the learning contents,
      consisted of 4 parts: airway evaluation, patient preparation, strategic planning and follow
      up care. The students' questionnaire comprised 3 parts: learning content, process and
      evaluation.

      The validation of the questionnaire was determined by three board-certified
      anesthesiologists. The index of item objective congruence was 0.80 and 0.82 with Cronbach's
      Alpha of 0.97 and 0.92 respectively.
Introduction Currently, teachers have emphasized the instructional strategies and enthusiasm
      in critical thinking to students to understand the educational course1. As coaching mentors,
      they search for innovative teaching models to reach the learning target 2. In anesthesia, a
      training program of nurse students involves several teaching methods such as seminars,
      journal clubs as well as topic, didactic, simulation and problem-based learning 13, 14.

      Simulation-based learning in medicine utilizes aides such as manikins or actors to replicate
      clinical scenarios. It yields the acquisition of skills through deliberate practice rather
      than an apprentice style of learning 22. However, problem-based learning is a small group
      discussions where students are active, learner-centered, or self-directed learning to the
      topic assignments. Teachers play role as moderators or facilitators 21.

      Teaching and learning in airway management are essential in anesthetic field. The personnel
      need to be keen both basic and advance knowledge owing to its applications to the benefits of
      patients' life. At present, the diversity of learning techniques (PBL and SBL) allows
      sophisticated devices as an interactive learning tool to cope with all difficulties in
      details.

      Nevertheless, neither PBL nor SBL manifests the superior benefit of instructional process and
      learning content xx. Chin KL, et al. (2014) concluded that simulation was superior to
      case-based learning in teaching diabetic ketoacidosis and thyroid storm to the final-year,
      undergraduate pharmacy students. Randolph H, et al. (2006) revealed that students who learned
      critical assessment and management skills using full-scale, high- fidelity simulation,
      performed better than students who acquired similar skills in an interactive problem-based
      learning format.

      As either PBL or SBL on difficult airway management is based upon the same table of
      specifications and experienced instructors. We would like to compare the teachers' and
      students' attitudes on these two learning methods.

      Objectives To compare between PBL and SBL in terms of learning content, instructional and
      evaluation methods

      Material and Methods After IRB approval No. 369/2558(EC3). A prospective,
      questionnaires-based study was performed amongst 40 volunteered, consent-signed nurse
      anesthetist students. The inclusion criteria for teachers were anesthesiologists who have
      involved in SBL and PBL with more than 3 years of experience in teaching. The inclusion
      criteria for students were nurse anesthetist students in the academic years of 2015. The
      exclusion criteria of both groups were ones who did not fit all qualifications.

      After stratified randomization, ten nurse anesthetist students attended either SBL or PBL
      course one at a time. The one-day workshops were performed simultaneously. Six weeks later, a
      crossover technique was applied for both groups. At the end of project, teachers and students
      had to response to Likert's scale questionnaires: 4 = very suitable, 3 = suitable, 2 =
      unsuitable, 1 = very unsuitable.

      The teachers' questionnaire based on table of specification of the learning contents,
      consisted of 4 parts: airway evaluation (history taking and physical examination), patient
      preparation (equipments and experienced helpers), 5 strategic planning (facemask ventilation,
      supraglottic airway device, laryngoscopy, tracheal intubation and failed intubation) and
      follow up care (documentation and informative advice).

      On the other hand, the students' questionnaires comprised 3 parts: learning content, process
      and evaluation.

      The correctness and appropriateness of the questionnaires (content validity) were determined
      by three board-certified anesthesiologists who had at least ten year experiences in
      anesthesia and were not involved in the project. The tryout was performed by ten novice nurse
      anesthetists and five anesthesiologists on students' and teachers' matters respectively. The
      index of item objective congruence was 0.80 and 0.82 with Cronbach's Alpha of 0.97 and 0.92
      respectively. We used percentage, mean, standard deviation and student t-Test for data
      analysis at the significant level of 0.05 with 95% confident interval.
time perspective: Cross-Sectional
measure: Student's point of view
time frame: 1 year
description: Likert's scale questionnaires 4 = very suitable, 3 = suitable, 2 = unsuitable, 1 = very unsuitable.
measure: Teacher's point of view
time frame: 1 year
description: Likert's scale questionnaires 4 = very suitable, 3 = suitable, 2 = unsuitable, 1 = very unsuitable.
arm group label: Teachers
description: Anesthesiologists who have involved in SBL and PBL with more than 3 years of experience in teaching
arm group label: Students
description: Students were nurse anesthetist students in the academic years of 2015
intervention type: Other
intervention name: Teacher
description: The teachers' questionnaire based on table of specification of the learning contents, consisted of 4 parts: airway evaluation, patient preparation, strategic planning and follow up care.
arm group label: Teachers
intervention type: Other
intervention name: Student
description: The students' questionnaire comprised 3 parts: learning content, process and evaluation.
arm group label: Students
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: No
last name: Mrs.Parichad Apidechakul, MPA. B.Ns.
role: Principal Investigator
affiliation: Department of Anesthesiology, Faculty of Medicine, Siriraj hospital
last name: Mrs.Parichad Apidechakul, MPA. B.Ns.
phone: 897942082
email: dao_pari@yahoo.com
last name: Phongthara Vichitvejpaisal, MD.PhD.
phone: 818384393
email: phongthara@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Thailand
citation: Reilly A, Spratt C. The perceptions of undergraduate student nurses of high-fidelity simulation-based learning: a case report from the University of Tasmania. Nurse Educ Today. 2007 Aug;27(6):542-50. doi: 10.1016/j.nedt.2006.08.015. Epub 2006 Oct 25.
PMID: 17069935
citation: Rowan CJ, McCourt C, Beake S. Problem based learning in midwifery--the students' perspective. Nurse Educ Today. 2008 Jan;28(1):93-9. doi: 10.1016/j.nedt.2007.02.014. Epub 2007 May 11.
PMID: 17499395
citation: Lorello GR, Cook DA, Johnson RL, Brydges R. Simulation-based training in anaesthesiology: a systematic review and meta-analysis. Br J Anaesth. 2014 Feb;112(2):231-45. doi: 10.1093/bja/aet414. Epub 2013 Dec 23.
PMID: 24368556
citation: Chilkoti G, Mohta M, Wadhwa R, Saxena AK. Problem-based learning research in anesthesia teaching: current status and future perspective. Anesthesiol Res Pract. 2014;2014:263948. doi: 10.1155/2014/263948. Epub 2014 May 29.
PMID: 24982673
citation: Al-Elq AH. Simulation-based medical teaching and learning. J Family Community Med. 2010 Jan;17(1):35-40. doi: 10.4103/1319-1683.68787.
PMID: 22022669
responsible party type: Principal Investigator
investigator affiliation: Siriraj Hospital
investigator full name: Mrs.Parichad Apidechakul
investigator title: Nurse anesthetist
sharing ipd: Undecided
submitted: March 5, 2017
returned: April 14, 2017
submitted: April 24, 2017
returned: August 3, 2017