<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/NCT03795077</url>
  </required_header>
  <id_info>
    <org_study_id>545879652</org_study_id>
    <nct_id>NCT03795077</nct_id>
  </id_info>
  <brief_title>Effect of a Programme Based on Professional Ethics in Physiotherapy Students</brief_title>
  <official_title>Effect of a Higher Education Programme Based on Professional Ethics in Physiotherapy Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valencia</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>
      The aim of this study was to assess the effect of a higher education programme based on&#xD;
      professional ethics in physiotherapy students.&#xD;
&#xD;
      A simple-blind clinical trial was performed. A three-months program based in professional&#xD;
      ethics was carried out.&#xD;
&#xD;
      The investigators compared a control group (traditonal lectures) with an intervention group&#xD;
      (syllabus, activities, face to face techniques). Students´ attitudes, knowledge, professional&#xD;
      values, and opinions towards professional ethics were evaluated before and after the&#xD;
      programme, in both groups. All participants were informed about the study and procedures, and&#xD;
      provided written informed consent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants. Second-year degree students of Physiotherapy Degree at the University, aged&#xD;
      between 20 and 30 years, were recruited voluntarily from January 2019 to April 2019 . All&#xD;
      enrolled participants were informed of the purpose of the study and procedures, and provided&#xD;
      written informed consent. The study was carried out at the institution where the authors&#xD;
      belong.&#xD;
&#xD;
      Research design. A prospective simple-blind trial was performed. After baseline assessment,&#xD;
      participants were allocated to one of the two groups (control group and experimental group).&#xD;
      An external assistant not involved in the study performed assignment.&#xD;
&#xD;
      Intervention. A Physiotherapy professor with over-10-year experience in Ethics and&#xD;
      Physiotherapy performed the teaching methodology and opened the allocation envelopes and&#xD;
      applied the teaching methodology to the EG according to the group assignment. The&#xD;
      intervention consisted of a three-month program based in professional ethics, including two&#xD;
      phases: A) syllabus and activities; and B) face to face group sessions including techniques&#xD;
      such as concept maps, glossaries, brainstorming, four corners activity, aquarium, philip 6-6,&#xD;
      kahoot, Realm Individual-Process Situation, reduced groups, guided debates, and discussion&#xD;
      groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">March 23, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge of Professional Ethicss</measure>
    <time_frame>12 weeks</time_frame>
    <description>measured with an ad-hoc retention test. The students were not previously informed about retention exams to avoid any preparation for the test. The tests included 15 multiple choice questions that assessed basic professional ethics concepts that physiotherapy students are required to know, such as: moral values, bioethics and Professional Ethics in physiotherapy, professional ethical principles, physiotherapists deontological code, ethical situations, or professional values in physiotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perception of knowledge regarding professional Ethics</measure>
    <time_frame>12 weeks</time_frame>
    <description>A self-reported questionnaire of 19 items (the Perceptions about Knowledge regarding Professional Ethics in Physiotherapy, PKPEPT, Cronbach's alpha=0.760) was previously described.27,28 The higher score indicated the best perception of knowlegde. The questionnaires' items included basic professional ethics concepts that physiotherapy students are required to know. Therefore, questions assessed participants' perception about knowledge regarding basic concepts in Professional Ethics and their application in physiotherapy care. Items were created in order to be important and to be clearly related with perception of knowledge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality assessment</measure>
    <time_frame>12 weeks</time_frame>
    <description>It was assessed for both groups by the Teaching evaluation of the Center for Quality of the University of Valencia. This center offers the students online surveys with different items evaluating the teaching methodologies, materials and general satisfaction by a Likert scale (1 totally disagree to 5 totally agree) in undergraduate degree, through the Virtual Office of the University.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction assessment</measure>
    <time_frame>12 weeks</time_frame>
    <description>For the Cooperative Learning group, an ad-hoc satisfaction questionnaire was carried out, using the Kahoot application. The satisfaction questionnaire included 16 questions in total: 5 dichotomous questions about opinion about the methodology, 5 dichotomous questions about the themes; 3 Likert-type questions (not at all / little / quite / a lot) about interest and usefulness of the content / contents, and 3 questions about satisfaction, usefulness and fun with respect to the techniques used, Likert-type: from 0 to 5 points. This evaluation was only carried out at the end of the program.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">241</enrollment>
  <condition>Ethics</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group followed traditional lectures about professional ethics during 3 months as usual.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group followed the programme based in professional ethics. A specific syllabus about Professional Ethics was developed. It consisted of 6 themes and included topics as moral values, ethics and moral, bioethics and professional ethics, ecc. Six related activities were created: to solve situations related to real clinical practices. Face to face group sessions based on cooperative learning were planned. Students were divided in small groups, and active participation techniques were used. Techniques used: concept maps, glossaries, brainstorming, four corners activity, aquarium, philip 6-6, kahoot, Realm Individual-Process Situation, reduced groups, guided debates, and discussion groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental group</intervention_name>
    <description>Experimental group followed the 3-months programme based in professional ethics. A specific syllabus about Professional Ethics was developed. It consisted of 6 themes and included topics as moral values, ethics and moral, bioethics and professional ethics, ecc. Six related activities were created: to solve situations related to real clinical practices. Face to face group sessions based on cooperative learning were planned. Students were divided in small groups, and active participation techniques were used.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To study the physical therapy degree at the University of Valencia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criterion was having prior training on Ethics subject&#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>
  <location>
    <facility>
      <name>University of Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>April 4, 2021</last_update_submitted>
  <last_update_submitted_qc>April 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Elena Marques-Sule</investigator_full_name>
    <investigator_title>PhD, PT, assisstant professor</investigator_title>
  </responsible_party>
  <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/NCT03795077
org study id: 545879652
nct id: NCT03795077
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to assess the effect of a higher education programme based on
      professional ethics in physiotherapy students.

      A simple-blind clinical trial was performed. A three-months program based in professional
      ethics was carried out.

      The investigators compared a control group (traditonal lectures) with an intervention group
      (syllabus, activities, face to face techniques). Students´ attitudes, knowledge, professional
      values, and opinions towards professional ethics were evaluated before and after the
      programme, in both groups. All participants were informed about the study and procedures, and
      provided written informed consent.
Participants. Second-year degree students of Physiotherapy Degree at the University, aged
      between 20 and 30 years, were recruited voluntarily from January 2019 to April 2019 . All
      enrolled participants were informed of the purpose of the study and procedures, and provided
      written informed consent. The study was carried out at the institution where the authors
      belong.

      Research design. A prospective simple-blind trial was performed. After baseline assessment,
      participants were allocated to one of the two groups (control group and experimental group).
      An external assistant not involved in the study performed assignment.

      Intervention. A Physiotherapy professor with over-10-year experience in Ethics and
      Physiotherapy performed the teaching methodology and opened the allocation envelopes and
      applied the teaching methodology to the EG according to the group assignment. The
      intervention consisted of a three-month program based in professional ethics, including two
      phases: A) syllabus and activities; and B) face to face group sessions including techniques
      such as concept maps, glossaries, brainstorming, four corners activity, aquarium, philip 6-6,
      kahoot, Realm Individual-Process Situation, reduced groups, guided debates, and discussion
      groups.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Knowledge of Professional Ethicss
time frame: 12 weeks
description: measured with an ad-hoc retention test. The students were not previously informed about retention exams to avoid any preparation for the test. The tests included 15 multiple choice questions that assessed basic professional ethics concepts that physiotherapy students are required to know, such as: moral values, bioethics and Professional Ethics in physiotherapy, professional ethical principles, physiotherapists deontological code, ethical situations, or professional values in physiotherapy.
measure: Perception of knowledge regarding professional Ethics
time frame: 12 weeks
description: A self-reported questionnaire of 19 items (the Perceptions about Knowledge regarding Professional Ethics in Physiotherapy, PKPEPT, Cronbach's alpha=0.760) was previously described.27,28 The higher score indicated the best perception of knowlegde. The questionnaires' items included basic professional ethics concepts that physiotherapy students are required to know. Therefore, questions assessed participants' perception about knowledge regarding basic concepts in Professional Ethics and their application in physiotherapy care. Items were created in order to be important and to be clearly related with perception of knowledge.
measure: Quality assessment
time frame: 12 weeks
description: It was assessed for both groups by the Teaching evaluation of the Center for Quality of the University of Valencia. This center offers the students online surveys with different items evaluating the teaching methodologies, materials and general satisfaction by a Likert scale (1 totally disagree to 5 totally agree) in undergraduate degree, through the Virtual Office of the University.
measure: Satisfaction assessment
time frame: 12 weeks
description: For the Cooperative Learning group, an ad-hoc satisfaction questionnaire was carried out, using the Kahoot application. The satisfaction questionnaire included 16 questions in total: 5 dichotomous questions about opinion about the methodology, 5 dichotomous questions about the themes; 3 Likert-type questions (not at all / little / quite / a lot) about interest and usefulness of the content / contents, and 3 questions about satisfaction, usefulness and fun with respect to the techniques used, Likert-type: from 0 to 5 points. This evaluation was only carried out at the end of the program.
arm group label: Control group
arm group type: No Intervention
description: Control group followed traditional lectures about professional ethics during 3 months as usual.
arm group label: Experimental group
arm group type: Experimental
description: Experimental group followed the programme based in professional ethics. A specific syllabus about Professional Ethics was developed. It consisted of 6 themes and included topics as moral values, ethics and moral, bioethics and professional ethics, ecc. Six related activities were created: to solve situations related to real clinical practices. Face to face group sessions based on cooperative learning were planned. Students were divided in small groups, and active participation techniques were used. Techniques used: concept maps, glossaries, brainstorming, four corners activity, aquarium, philip 6-6, kahoot, Realm Individual-Process Situation, reduced groups, guided debates, and discussion groups.
intervention type: Other
intervention name: Experimental group
description: Experimental group followed the 3-months programme based in professional ethics. A specific syllabus about Professional Ethics was developed. It consisted of 6 themes and included topics as moral values, ethics and moral, bioethics and professional ethics, ecc. Six related activities were created: to solve situations related to real clinical practices. Face to face group sessions based on cooperative learning were planned. Students were divided in small groups, and active participation techniques were used.
arm group label: Experimental group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Elena Marques-Sule
investigator title: PhD, PT, assisstant professor
sharing ipd: No