<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/NCT04469660</url>
  </required_header>
  <id_info>
    <org_study_id>Onco Survey_COVID-19</org_study_id>
    <nct_id>NCT04469660</nct_id>
  </id_info>
  <brief_title>Impact of COVID-19 Pandemic on the Psychological Wellbeing of Healthcare Professionals in India</brief_title>
  <official_title>Impact of COVID-19 Pandemic on the Psychological Wellbeing of Healthcare</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Max Healthcare Insititute Limited</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Max Healthcare Insititute Limited</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>
      To Study the epidemiology of psychological distress among healthcare professionals of Max&#xD;
      Super Speciality Hospital,Saket ,New Delhi in India during the COVID-19 Pandemic and assess&#xD;
      the implications for providing psychological interventions(or therapeutic services)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To Study the epidemiology of psychological distress among healthcare professionals of Max&#xD;
      Super Speciality Hospital,Saket ,New Delhi in India during the COVID-19 Pandemic and assess&#xD;
      the implications for providing psychological interventions(or therapeutic services).&#xD;
&#xD;
      Hypothesis: There is likelihood of psychological distress impacting healthcare professionals'&#xD;
      mental well-being as a result of their role in the healthcare setup during the COVID-19&#xD;
      pandemic. Study design-The questionnaire assessing the psychological wellbeing shall be&#xD;
      administered via digital means of communication to healthcare professionals and support staff&#xD;
      (doctors, nurses, paramedics, front office and support staff) across Max Super Speciality&#xD;
      Hospital, Saket, New Delhi that currently employs 1295 individuals in the current category.&#xD;
&#xD;
      Participation in the study will be voluntary and informed consent will be sought prior to the&#xD;
      survey administration. Participants' responses will remain anonymous, with an assurance of&#xD;
      confidentiality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 18, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Therapeutic Sessions emphasizing on Stress</measure>
    <time_frame>3 Months</time_frame>
    <description>The therapeutic sessions will emphasize on aspects of anxiety, depression, grief, post traumatic impact, loss, fear and so on, using standardized therapeutic techniques of psychotherapy. If the individual is in need of further management or somatic symptom related treatment, they will be guided for pharmacotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resilience building and planning</measure>
    <time_frame>3 Months</time_frame>
    <description>Resilience building and planning will be implemented via individual, group and/or online based training portals to the cohort falling in the range of mild-moderate levels of psychological distress.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1300</enrollment>
  <condition>Psychological Stress</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthcare Professionals of Max Super Speciality Hospital,Saket,New Delhi&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria Healthcare professionals working in Max Super Speciality Hospital Saket&#xD;
        New Delhi Healthcare professionals inclusive of doctors, nurses paramedics front office&#xD;
        employee and support staff Healthcare professionals above 18 years of age Healthcare&#xD;
        professionals residing in India&#xD;
&#xD;
        Exclusion Criteria Non-employees of Max Super Speciality Hospital Saket New Delh Healthcare&#xD;
        professionals residing outside India&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hiba Siddiqui</last_name>
    <role>Principal Investigator</role>
    <affiliation>Max Super Speciality Hospital,Saket,New Delhi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Siddiqui</last_name>
    <phone>9911175205</phone>
    <email>hiba.siddiqui16@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ramandeep Arora</last_name>
    <phone>8375017305</phone>
    <email>childhoodcancer@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Max Super Speciality Hospital Saket</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110017</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hiba Siddiqui</last_name>
      <phone>9911175205</phone>
      <email>hiba.siddiqui16@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ramandeep S Arora</last_name>
      <phone>8375017305</phone>
      <email>childhoodcancer@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Yet not decided</ipd_description>
  </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/NCT04469660
org study id: Onco Survey_COVID-19
nct id: NCT04469660
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To Study the epidemiology of psychological distress among healthcare professionals of Max
      Super Speciality Hospital,Saket ,New Delhi in India during the COVID-19 Pandemic and assess
      the implications for providing psychological interventions(or therapeutic services)
To Study the epidemiology of psychological distress among healthcare professionals of Max
      Super Speciality Hospital,Saket ,New Delhi in India during the COVID-19 Pandemic and assess
      the implications for providing psychological interventions(or therapeutic services).

      Hypothesis: There is likelihood of psychological distress impacting healthcare professionals'
      mental well-being as a result of their role in the healthcare setup during the COVID-19
      pandemic. Study design-The questionnaire assessing the psychological wellbeing shall be
      administered via digital means of communication to healthcare professionals and support staff
      (doctors, nurses, paramedics, front office and support staff) across Max Super Speciality
      Hospital, Saket, New Delhi that currently employs 1295 individuals in the current category.

      Participation in the study will be voluntary and informed consent will be sought prior to the
      survey administration. Participants' responses will remain anonymous, with an assurance of
      confidentiality.
observational model: Cohort
time perspective: Prospective
measure: Therapeutic Sessions emphasizing on Stress
time frame: 3 Months
description: The therapeutic sessions will emphasize on aspects of anxiety, depression, grief, post traumatic impact, loss, fear and so on, using standardized therapeutic techniques of psychotherapy. If the individual is in need of further management or somatic symptom related treatment, they will be guided for pharmacotherapy.
measure: Resilience building and planning
time frame: 3 Months
description: Resilience building and planning will be implemented via individual, group and/or online based training portals to the cohort falling in the range of mild-moderate levels of psychological distress.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hiba Siddiqui
role: Principal Investigator
affiliation: Max Super Speciality Hospital,Saket,New Delhi
last name: Siddiqui
phone: 9911175205
email: hiba.siddiqui16@gmail.com
last name: Ramandeep Arora
phone: 8375017305
email: childhoodcancer@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: India
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Stress, Psychological
sharing ipd: Undecided
ipd description: Yet not decided