PTSD of Surgeons or Anesthesiologists on Prognosis of Surgical Patients

April 2, 2025 updated by: Chong Lei, MD & phD, Xijing Hospital

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

The objective of this prospective cohort study is to explore the association between the development of post-traumatic stress disorder (PTSD) in surgeons and anesthesiologists and postoperative prognosis in surgical patients they care for during the COVID-19 pandemic. There are 2 cohorts included in this study. The first cohort consists of registered surgeons and anesthesiologists in the study center. The development of PTSD will be evaluated with a series of questionnaires and scales. This cohort defines exposure (with PTSD). The second cohort consists of surgical patients managed by the surgeons and anesthesiologists in the first cohort. The postoperative outcome of these patients will be evaluated thus to explore the association between PTSD in physicians and adverse patient outcomes. The second cohort defines the outcomes( response).

Study Overview

Status

Recruiting

Conditions

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

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo No.2 Hospital
        • Contact:
          • Junping Chen, MD
        • Contact:
          • Jinwei Zheng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

There are 2 cohorts included in this study. The first cohort consists of registered surgeons and anesthesiologists in the study center. The development of PTSD will be evaluated with a series of questionnaires and scales. This cohort defines exposure (with PTSD). The second cohort consists of surgical patients cared by the surgeons and anesthesiologists in the first cohort. The postoperative outcome of these patients will be evaluate thus to explore the association of PTSD in physicians and adverse patient outcomes. The second cohort defines the outcome( response).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposure: With PTSD
Surgeons or anesthesiologists with PTSD
Other: PTSD
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:
  • With PTSD
Comparator: Without PTSD
Surgeons or anesthesiologists without PTSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications of surgical patients cared by these surgeons and anesthesiologists
Time Frame: During hospitalization or within 7 days postoperatively, whichever comes first
postoperarive complications of patients whose surgery was performed by surgeons or anesthesiologists who participates in the study
During hospitalization or within 7 days postoperatively, whichever comes first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pulmonary complications of surgical patients cared by these surgeons and anesthesiologists
Time Frame: During hospitalization or within 7 days postoperatively, whichever comes first
Postoperative pulmonary related adverse events, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis.
During hospitalization or within 7 days postoperatively, whichever comes first
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
the duration between end of surgery to discharge from hospital
From the date of surgery until patients discharged from hospital, assessed up to 30 days
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
Percentage of patients admission to ICU for which is unexpected before surgery.
From the date of surgery until patients discharged from hospital, assessed up to 30 days
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
defined as comfirmed death or discharge to hospice.
From the date of surgery until patients discharged from hospital, assessed up to 30 days
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
including acute kidney injury, myocardial infarction and stroke
During hospitalization or within 7 days postoperatively，whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Ningbo No.2 Hospital

Investigators

  • Principal Investigator: Chong Lei, MD&phD, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-20230081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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