<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/NCT04422834</url>
  </required_header>
  <id_info>
    <org_study_id>BakircayU07/07022020</org_study_id>
    <nct_id>NCT04422834</nct_id>
  </id_info>
  <brief_title>Translation and Validation of the Turkish Version of JSE-HPS</brief_title>
  <acronym>JSE-HPS</acronym>
  <official_title>The Reliability, Validity and Cross-Cultural Adaptation of the Turkish Version of Jefferson Scale of Empathy For Health Professional Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Izmir Bakircay University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Izmir Bakircay University</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>
      Empathy, which can be briefly defined as understanding and feeling of one's thoughts upon&#xD;
      experiences. It has been gaining importance in health care. A great majority of the&#xD;
      literature has been focusing on the aspect of physician and health care provider yet recently&#xD;
      establishing or measuring empathy has been performed with the undergraduate students. Since&#xD;
      empathy and its related dimensions are important to integrate a better skill to provide in&#xD;
      health care, measuring empathy gained attention. However, there might be lacking some tools&#xD;
      which assess empathy directly such as the Empathic Tendency Scale and the Empathic Skill&#xD;
      Scale in the Turkish language, yet these were discussed as cannot be quite modifiable to some&#xD;
      specific sub-groups such as health sciences students. Thus, this study is aimed to study for&#xD;
      the reliability, validity, and cross-cultural adaptation of the Turkish version of the&#xD;
      Jefferson Scale of Empathy for undergraduate health care students.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research has been aimed at studying translation, validation, a cross-cultural adaptation&#xD;
      of the Turkish version of the Jefferson Scale of Empathy for Health Professional Students&#xD;
      (JSE-HPS).&#xD;
&#xD;
      Study Setting:&#xD;
&#xD;
      This research was planned as a descriptive study. The research is planning to be performed&#xD;
      between May 2020 and October 2020. The students who are currently studying in the Faculty of&#xD;
      Health Sciences will be asked to participate in this study. Since ethical board approval was&#xD;
      taken in February 2020 and study was planned to start in March or April 2020. However, due to&#xD;
      the Covid-19 pandemic, the research in which test and re-test protocols should be performed&#xD;
      by students was re-planned by doing these protocols via internet-based forms. Before the&#xD;
      study, all participating students were informed about this study. To achieve their consent in&#xD;
      regard to participate in this study, a &quot;tick-box&quot; was placed prior to the questionnaire in&#xD;
      which whether they accept that participating in this study voluntarily. The primary target&#xD;
      for sample size was set as 300 students.&#xD;
&#xD;
      Measurement and Method:&#xD;
&#xD;
      The descriptive data will be gathered by using the Jefferson Scale of Empathy for health&#xD;
      professional students (JSE-HPS), the Turkish version of Empathic tendency scale (ETS), and&#xD;
      sociodemographic form in which age, gender, and other information will be requested to fill&#xD;
      out.&#xD;
&#xD;
      JSE-HPS:&#xD;
&#xD;
      JSE-HPS was originally developed by Jefferson University. It consists of 20 items each scored&#xD;
      according to the seven-point Likert type scale in which 1 means &quot;Strongly Disagree&quot; while 7&#xD;
      means &quot;Strongly agree&quot;. The minimum and maximum scores range from 20 to 140. Higher scores&#xD;
      indicate a better empathic aspect or vice versa.&#xD;
&#xD;
      Empathic Tendency Scale (ETS):&#xD;
&#xD;
      ETS was originally developed in the Turkish language in 1988. Turkish validation and&#xD;
      reliability of ETS were also conducted and found to reliable according to the Cronbach's&#xD;
      alpha value is 0.82. ETS consists of 20 items each scored according to the five-point Likert&#xD;
      type scale in which 1 equals &quot;Completely contradictory&quot; while 5 means &quot;Completely proper&quot;.&#xD;
      Each item is related to some ideas which are quite common in daily life. 20 and 100 are&#xD;
      minimum and maximum scores, respectively. Higher scores indicate a better empathic aspect.&#xD;
&#xD;
      Translation and Cross-cultural Adaptation Process:&#xD;
&#xD;
      The permission was granted from the copyright Holder of JSE-HPS in order to study the&#xD;
      reliability, validity, and adaptation of the Turkish version of JSE-HPS. The cultural&#xD;
      adaptation was performed according to the protocol explained by Beaton et al. Steps and a&#xD;
      detailed explanation of this protocol can be found in the literature. Briefly, an expert&#xD;
      committee consists of study researchers separately translated the original version of the&#xD;
      JSE-HPS into Turkish. The final version of the Turkish translated JSE-HPS was created&#xD;
      according to the separately translated ones. This final version was re-translated to English&#xD;
      by a native English speaker who is also capable to talk Turkish language. The expert&#xD;
      committee eventually made a final version to which can be applicable to the participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2020</start_date>
  <completion_date type="Actual">December 10, 2020</completion_date>
  <primary_completion_date type="Actual">April 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A group of students who studying at Faculty of Health Sciences will be asked to fill Turkish version of JSE-HPS and ETS. JSE-HPS will be asked to re-fill after seven days for retest analysis.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Jefferson Scale of Empathy Health Professional Students Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>The Turkish version of Jefferson Scale of Empathy Health Professional Students (JSE-HPS) will be applied to participants. The minimum and maximum scores for JSE-HPS can be reached to 20 and 140, respectively. The more the higher scores indicate more empathic aspect or vice versa.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Jefferson Scale of Empathy Health Professional Students Questionnaire</measure>
    <time_frame>1 week after baseline</time_frame>
    <description>The Turkish version of Jefferson Scale of Empathy Health Professional Students (JSE-HPS) will be applied to participants. The minimum and maximum scores for JSE-HPS can be reached to 20 and 140, respectively. The more the higher scores indicate more empathic aspect or vice versa.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Empathic Tendency Scale (ETS) Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>The Turkish version of Empathic Tendency Scale (ETS) Questionnaire will be applied to participants. The minimum and maximum scores can be taken from the tool are 20 and 100, respectively in which higher scores indicate better empathic attitude or vice versa.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demographic Data Form</measure>
    <time_frame>Baseline</time_frame>
    <description>Basic Form gathers some information related participants' age, gender etc.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">167</enrollment>
  <condition>Surveys and Questionnaires</condition>
  <condition>Empathy</condition>
  <arm_group>
    <arm_group_label>Health Professional Students</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group of students who studying at the Faculty of Health Sciences will be asked to fill the Turkish version of JSE-HPS and ETS. JSE-HPS will be asked to re-fill after seven days for retest analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>A group of students who studying at the Faculty of Health Sciences will be asked to fill the Turkish version of JSE-HPS and ETS. JSE-HPS will be asked to re-fill after seven days for retest analysis.</description>
    <arm_group_label>Health Professional Students</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being currently studying at the Faculty of Health Sciences&#xD;
&#xD;
          -  Able to read, write and understand the Turkish language&#xD;
&#xD;
          -  Having no mental medical conditions&#xD;
&#xD;
          -  Being a volunteer to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to read, write and understand Turkish language&#xD;
&#xD;
          -  Not volunteer to participate in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elif Günay İsmailoğlu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Izmir Bakircay University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kadirhan Özdemir, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Izmir Bakircay University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>İzmir Bakırçay University</name>
      <address>
        <city>İzmir</city>
        <zip>35565</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Anfossi M, Numico G. Empathy in the doctor-patient relationship. J Clin Oncol. 2004 Jun 1;22(11):2258-9; author reply 2259-60. doi: 10.1200/JCO.2004.99.302. No abstract available.</citation>
    <PMID>15169824</PMID>
  </reference>
  <reference>
    <citation>Hojat M, Louis DZ, Markham FW, Wender R, Rabinowitz C, Gonnella JS. Physicians' empathy and clinical outcomes for diabetic patients. Acad Med. 2011 Mar;86(3):359-64. doi: 10.1097/ACM.0b013e3182086fe1.</citation>
    <PMID>21248604</PMID>
  </reference>
  <reference>
    <citation>Kim SS, Kaplowitz S, Johnston MV. The effects of physician empathy on patient satisfaction and compliance. Eval Health Prof. 2004 Sep;27(3):237-51. doi: 10.1177/0163278704267037.</citation>
    <PMID>15312283</PMID>
  </reference>
  <reference>
    <citation>Hogan R. Development of an empathy scale. J Consult Clin Psychol. 1969 Jun;33(3):307-16. doi: 10.1037/h0027580. No abstract available.</citation>
    <PMID>4389335</PMID>
  </reference>
  <reference>
    <citation>Fields SK, Hojat M, Gonnella JS, Mangione S, Kane G, Magee M. Comparisons of nurses and physicians on an operational measure of empathy. Eval Health Prof. 2004 Mar;27(1):80-94. doi: 10.1177/0163278703261206.</citation>
    <PMID>14994561</PMID>
  </reference>
  <reference>
    <citation>Sherman JJ, Cramer A. Measurement of changes in empathy during dental school. J Dent Educ. 2005 Mar;69(3):338-45.</citation>
    <PMID>15749944</PMID>
  </reference>
  <reference>
    <citation>Fields SK, Mahan P, Tillman P, Harris J, Maxwell K, Hojat M. Measuring empathy in healthcare profession students using the Jefferson Scale of Physician Empathy: health provider--student version. J Interprof Care. 2011 Jul;25(4):287-93. doi: 10.3109/13561820.2011.566648. Epub 2011 May 9.</citation>
    <PMID>21554061</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>December 13, 2020</last_update_submitted>
  <last_update_submitted_qc>December 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Izmir Bakircay University</investigator_affiliation>
    <investigator_full_name>Alper Tuğral</investigator_full_name>
    <investigator_title>Alper Tuğral</investigator_title>
  </responsible_party>
  <keyword>Jefferson Scale of Empathy</keyword>
  <keyword>Empathy</keyword>
  <keyword>Questionnaire</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/NCT04422834
org study id: BakircayU07/07022020
nct id: NCT04422834
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Empathy, which can be briefly defined as understanding and feeling of one's thoughts upon
      experiences. It has been gaining importance in health care. A great majority of the
      literature has been focusing on the aspect of physician and health care provider yet recently
      establishing or measuring empathy has been performed with the undergraduate students. Since
      empathy and its related dimensions are important to integrate a better skill to provide in
      health care, measuring empathy gained attention. However, there might be lacking some tools
      which assess empathy directly such as the Empathic Tendency Scale and the Empathic Skill
      Scale in the Turkish language, yet these were discussed as cannot be quite modifiable to some
      specific sub-groups such as health sciences students. Thus, this study is aimed to study for
      the reliability, validity, and cross-cultural adaptation of the Turkish version of the
      Jefferson Scale of Empathy for undergraduate health care students.
The research has been aimed at studying translation, validation, a cross-cultural adaptation
      of the Turkish version of the Jefferson Scale of Empathy for Health Professional Students
      (JSE-HPS).

      Study Setting:

      This research was planned as a descriptive study. The research is planning to be performed
      between May 2020 and October 2020. The students who are currently studying in the Faculty of
      Health Sciences will be asked to participate in this study. Since ethical board approval was
      taken in February 2020 and study was planned to start in March or April 2020. However, due to
      the Covid-19 pandemic, the research in which test and re-test protocols should be performed
      by students was re-planned by doing these protocols via internet-based forms. Before the
      study, all participating students were informed about this study. To achieve their consent in
      regard to participate in this study, a "tick-box" was placed prior to the questionnaire in
      which whether they accept that participating in this study voluntarily. The primary target
      for sample size was set as 300 students.

      Measurement and Method:

      The descriptive data will be gathered by using the Jefferson Scale of Empathy for health
      professional students (JSE-HPS), the Turkish version of Empathic tendency scale (ETS), and
      sociodemographic form in which age, gender, and other information will be requested to fill
      out.

      JSE-HPS:

      JSE-HPS was originally developed by Jefferson University. It consists of 20 items each scored
      according to the seven-point Likert type scale in which 1 means "Strongly Disagree" while 7
      means "Strongly agree". The minimum and maximum scores range from 20 to 140. Higher scores
      indicate a better empathic aspect or vice versa.

      Empathic Tendency Scale (ETS):

      ETS was originally developed in the Turkish language in 1988. Turkish validation and
      reliability of ETS were also conducted and found to reliable according to the Cronbach's
      alpha value is 0.82. ETS consists of 20 items each scored according to the five-point Likert
      type scale in which 1 equals "Completely contradictory" while 5 means "Completely proper".
      Each item is related to some ideas which are quite common in daily life. 20 and 100 are
      minimum and maximum scores, respectively. Higher scores indicate a better empathic aspect.

      Translation and Cross-cultural Adaptation Process:

      The permission was granted from the copyright Holder of JSE-HPS in order to study the
      reliability, validity, and adaptation of the Turkish version of JSE-HPS. The cultural
      adaptation was performed according to the protocol explained by Beaton et al. Steps and a
      detailed explanation of this protocol can be found in the literature. Briefly, an expert
      committee consists of study researchers separately translated the original version of the
      JSE-HPS into Turkish. The final version of the Turkish translated JSE-HPS was created
      according to the separately translated ones. This final version was re-translated to English
      by a native English speaker who is also capable to talk Turkish language. The expert
      committee eventually made a final version to which can be applicable to the participants.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A group of students who studying at Faculty of Health Sciences will be asked to fill Turkish version of JSE-HPS and ETS. JSE-HPS will be asked to re-fill after seven days for retest analysis.
primary purpose: Basic Science
masking: None (Open Label)
measure: Jefferson Scale of Empathy Health Professional Students Questionnaire
time frame: Baseline
description: The Turkish version of Jefferson Scale of Empathy Health Professional Students (JSE-HPS) will be applied to participants. The minimum and maximum scores for JSE-HPS can be reached to 20 and 140, respectively. The more the higher scores indicate more empathic aspect or vice versa.
measure: Jefferson Scale of Empathy Health Professional Students Questionnaire
time frame: 1 week after baseline
description: The Turkish version of Jefferson Scale of Empathy Health Professional Students (JSE-HPS) will be applied to participants. The minimum and maximum scores for JSE-HPS can be reached to 20 and 140, respectively. The more the higher scores indicate more empathic aspect or vice versa.
measure: Empathic Tendency Scale (ETS) Questionnaire
time frame: Baseline
description: The Turkish version of Empathic Tendency Scale (ETS) Questionnaire will be applied to participants. The minimum and maximum scores can be taken from the tool are 20 and 100, respectively in which higher scores indicate better empathic attitude or vice versa.
measure: Demographic Data Form
time frame: Baseline
description: Basic Form gathers some information related participants' age, gender etc.
arm group label: Health Professional Students
arm group type: Experimental
description: A group of students who studying at the Faculty of Health Sciences will be asked to fill the Turkish version of JSE-HPS and ETS. JSE-HPS will be asked to re-fill after seven days for retest analysis.
intervention type: Other
intervention name: Questionnaire
description: A group of students who studying at the Faculty of Health Sciences will be asked to fill the Turkish version of JSE-HPS and ETS. JSE-HPS will be asked to re-fill after seven days for retest analysis.
arm group label: Health Professional Students
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elif Günay İsmailoğlu, PhD
role: Principal Investigator
affiliation: Izmir Bakircay University
last name: Kadirhan Özdemir, PhD
role: Principal Investigator
affiliation: Izmir Bakircay University
facility: 
country: Turkey
citation: Anfossi M, Numico G. Empathy in the doctor-patient relationship. J Clin Oncol. 2004 Jun 1;22(11):2258-9; author reply 2259-60. doi: 10.1200/JCO.2004.99.302. No abstract available.
PMID: 15169824
citation: Hojat M, Louis DZ, Markham FW, Wender R, Rabinowitz C, Gonnella JS. Physicians' empathy and clinical outcomes for diabetic patients. Acad Med. 2011 Mar;86(3):359-64. doi: 10.1097/ACM.0b013e3182086fe1.
PMID: 21248604
citation: Kim SS, Kaplowitz S, Johnston MV. The effects of physician empathy on patient satisfaction and compliance. Eval Health Prof. 2004 Sep;27(3):237-51. doi: 10.1177/0163278704267037.
PMID: 15312283
citation: Hogan R. Development of an empathy scale. J Consult Clin Psychol. 1969 Jun;33(3):307-16. doi: 10.1037/h0027580. No abstract available.
PMID: 4389335
citation: Fields SK, Hojat M, Gonnella JS, Mangione S, Kane G, Magee M. Comparisons of nurses and physicians on an operational measure of empathy. Eval Health Prof. 2004 Mar;27(1):80-94. doi: 10.1177/0163278703261206.
PMID: 14994561
citation: Sherman JJ, Cramer A. Measurement of changes in empathy during dental school. J Dent Educ. 2005 Mar;69(3):338-45.
PMID: 15749944
citation: Fields SK, Mahan P, Tillman P, Harris J, Maxwell K, Hojat M. Measuring empathy in healthcare profession students using the Jefferson Scale of Physician Empathy: health provider--student version. J Interprof Care. 2011 Jul;25(4):287-93. doi: 10.3109/13561820.2011.566648. Epub 2011 May 9.
PMID: 21554061
responsible party type: Principal Investigator
investigator affiliation: Izmir Bakircay University
investigator full name: Alper Tuğral
investigator title: Alper Tuğral
sharing ipd: No