- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05732116
PTSD of Surgeons or Anesthesiologists on Prognosis of Surgical Patients
Effect of Post-traumatic Stress Disorder (PTSD) of Surgeons and Anesthesiologists on Postoperative Complications of Surgical Patients Under the Background of the COVID-19 Pandemic
Study Overview
Status
Intervention / Treatment
Detailed Description
The outbreak of COVID-19 and its global pandemic has posed a threat to public health. On December 7, 2022, the National Health Commission (NHC) of China issued an announcement on further optimization of public health control measures. Since then, the rapid spread and breakthrough of SARS-CoV-2 infections have been observed in the majority of China, involving medical professionals and the general public.
Epidemiological studies have demonstrated a rather high prevalence of mental health problems among medical professionals. While most of these mental health problems will fade out after the epidemic, symptoms of PTSD may last for a prolonged time and result in serious distress and disability. Recent studies have shown that post-COVID stress disorder may be an emerging consequence of the global pandemic for physicians and other healthcare workers.
Directly experiencing and suffering from the symptoms; witnessing patients and family members who suffer from, struggle against the infectious disease and dramatically increased working load and working hours when the physical condition of the physician themselves is not fully recovered from the previous COVID-19 infection or fear of infection are some of the main factors that contributed to the development of PTSD in healthcare workers (HCW). Pooled evidence indicated the prevalence estimates of PTSD in HCW range from 7-37% via an online survey using screening tools. A recent study (Lancet Psychiatry 2023; 10: 40-49) that using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) diagnostic interviews so as to provide an accurate estimation of PTSD prevalence. It reported that the estimated population prevalence of PTSD was 7·9% (4·0-15·1) in HCWs during the COVID-19 pandemic in UK.
Although with the prevalence of PTSD in surgeons and anesthesiologists during the COVID-19 pandemic, the impact of poor wellness of surgery-related HCWs on objective surgical patient outcomes (eg, morbidity or mortality) is unclear as existing studies are limited to physician and patient self-report of events and errors, small cohorts, or examine few outcomes. Therefore, in the prospective cohort study, the association between the development of post-traumatic stress disorder (PTSD) in surgeons and anesthesiologists and postoperative prognosis in objective surgical patients they care for during the COVID-19 pandemic is explored.
Cross-sectional surveys, including the 12-item General Health Questionnaire (GHQ-12) and the Clinical Interview Schedule-Revised (CIS-R) for common mental disorders, or the 6-item Post-Traumatic Stress Disorder Checklist (PCL-6) will be used for screening, while the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) for diagnosing of PTSD at baseline (time 0, February of 2023), 3-month (May of 2023), and 6- month(August of 2023). Postoperative patient outcomes were ascertained using a validated national clinical data registry.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Xi'an, China, 710032
- Xijing Hospital
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Zhejiang
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Ningbo, Zhejiang, China
- Ningbo No.2 Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Registered Surgeons and anesthesiologists in the study center
Exclusion Criteria:
- Surgeons and anesthesiologists with potential practice location changes during the study periods
- Refuse to sign written informed consent and fill out the evaluation questionnaire
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Exposure: With PTSD
Surgeons or anesthesiologists with PTSD
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Series scales, including GHQ-12, PCL-6, and CAPS-5 will be used to screen and diagnose the development of PTSD in surgeons and anesthesiologists at 3 time points, baseline (time 0), 3 m, and 6 m.
Other Names:
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Comparator: Without PTSD
Surgeons or anesthesiologists without PTSD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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postoperative complications of surgical patients cared by these surgeons and anesthesiologists
Time Frame: During hospitalization or within 7 days postoperatively, whichever comes first
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postoperarive complications of patients whose surgery was performed by surgeons or anesthesiologists who participates in the study
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During hospitalization or within 7 days postoperatively, whichever comes first
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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postoperative pulmonary complications of surgical patients cared by these surgeons and anesthesiologists
Time Frame: During hospitalization or within 7 days postoperatively, whichever comes first
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Postoperative pulmonary related adverse events, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis.
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During hospitalization or within 7 days postoperatively, whichever comes first
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postoperative length of hospital stay of surgical patients cared by these surgeons and anesthesiologists
Time Frame: From the date of surgery until patients discharged from hospital, assessed up to 30 days
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the duration between end of surgery to discharge from hospital
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From the date of surgery until patients discharged from hospital, assessed up to 30 days
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postoperative unplanned ICU admission rate of surgical patients cared by these surgeons and anesthesiologists
Time Frame: From the date of surgery until patients discharged from hospital, assessed up to 30 days
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Percentage of patients admission to ICU for which is unexpected before surgery.
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From the date of surgery until patients discharged from hospital, assessed up to 30 days
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all cause in-hospital mortality of surgical patients cared by these surgeons and anesthesiologists
Time Frame: From the date of surgery until patients discharged from hospital, assessed up to 30 days
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defined as comfirmed death or discharge to hospice.
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From the date of surgery until patients discharged from hospital, assessed up to 30 days
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Incidence of serious adverse events after operation of surgical patients cared by these surgeons and anesthesiologists
Time Frame: During hospitalization or within 7 days postoperatively,whichever comes first
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including acute kidney injury, myocardial infarction and stroke
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During hospitalization or within 7 days postoperatively,whichever comes first
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chong Lei, MD&phD, Xijing Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Mental Disorders
- Pathologic Processes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Stress Disorders, Traumatic
- Pathological Conditions, Signs and Symptoms
- COVID-19
- Stress Disorders, Post-Traumatic
- Postoperative Complications
Other Study ID Numbers
- KY-20230081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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