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Humanistic Care in Healthcare Workers in Coronavirus Disease 2019

Primary Purpose

Coronavirus Disease 2019

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Humanistic Care
Sponsored by
Second Affiliated Hospital of Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronavirus Disease 2019 focused on measuring coronavirus disease 2019, Humanistic Care, mental health, post-traumatic stress disorder, Healthcare Workers

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthcare-personnel who are working for treating COVID-19
  • Agree to informed consent

Exclusion Criteria:

  • disagree to consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Humanistic care

    Arm Description

    Psychological and physical rehabilitation based humanistic care regimen was used to prevent depression and PTSD in healthcare workers who participated in the treatment of COVID-19.

    Outcomes

    Primary Outcome Measures

    Self-rating depression scale
    Self-rating depression scale will be finished from healthcare workers by a scale table designed by investigator

    Secondary Outcome Measures

    Incidence of PTSD
    the incidence of post-traumatic stress disorder in healthcare workers

    Full Information

    First Posted
    February 22, 2020
    Last Updated
    March 14, 2020
    Sponsor
    Second Affiliated Hospital of Xi'an Jiaotong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04283838
    Brief Title
    Humanistic Care in Healthcare Workers in Coronavirus Disease 2019
    Official Title
    The Effect of Humanistic Care in Healthcare Workers Participated in the Treatment of Coronavirus Disease 2019
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    We cannot enroll enough participants.
    Study Start Date
    February 22, 2020 (Anticipated)
    Primary Completion Date
    April 30, 2020 (Anticipated)
    Study Completion Date
    May 15, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital of Xi'an Jiaotong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. The impact factors of clinical outcomes among hospitalized patients still need to be clarified. The healthcare workers faced greater mental and physical pressure under long-term, high-intensity, high-risk working conditions. Investigators aim to evaluate the positive effect of humanistic care for healthcare workers participated in the treatment of COVID-19.
    Detailed Description
    As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. As the national medical team sent to Wuhan, the investigators proposed a psychological and physical rehabilitation based humanistic care regimen generated from experience in treating patients with COVID-19. The healthcare workers faced greater mental and physical pressure under long-term, high-intensity, high-risk working conditions. The investigators want to apply this regimen to the healthcare workers who participated in the treatment of COVID-19, to evaluate the positive effect of humanistic care on preventing depression and post-traumatic stress disorder.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronavirus Disease 2019
    Keywords
    coronavirus disease 2019, Humanistic Care, mental health, post-traumatic stress disorder, Healthcare Workers

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Humanistic care
    Arm Type
    Experimental
    Arm Description
    Psychological and physical rehabilitation based humanistic care regimen was used to prevent depression and PTSD in healthcare workers who participated in the treatment of COVID-19.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Humanistic Care
    Intervention Description
    Psychological and physical rehabilitation based humanistic care regimen
    Primary Outcome Measure Information:
    Title
    Self-rating depression scale
    Description
    Self-rating depression scale will be finished from healthcare workers by a scale table designed by investigator
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Incidence of PTSD
    Description
    the incidence of post-traumatic stress disorder in healthcare workers
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Healthcare-personnel who are working for treating COVID-19 Agree to informed consent Exclusion Criteria: disagree to consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shouping Gong, MD, PhD
    Organizational Affiliation
    Second Affiliated Hospital of Xi'an Jiaotong University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Humanistic Care in Healthcare Workers in Coronavirus Disease 2019

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