PTSD of Surgeons or Anesthesiologists on Prognosis of Surgical Patients

Sponsor

Xijing Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05732116

Collaborator

(none)

10,000

Enrollment

10.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder Postoperative Complications COVID-19	Other: PTSD

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 Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Feb 15, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

postoperative complications of surgical patients cared by these surgeons and anesthesiologists [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

Secondary Outcome Measures

postoperative pulmonary complications of surgical patients cared by these surgeons and anesthesiologists [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.
postoperative length of hospital stay of surgical patients cared by these surgeons and anesthesiologists [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
postoperative unplanned ICU admission rate of surgical patients cared by these surgeons and anesthesiologists [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.
all cause in-hospital mortality of surgical patients cared by these surgeons and anesthesiologists [From the date of surgery until patients discharged from hospital, assessed up to 30 days]
defined as comfirmed death or discharge to hospice.
Incidence of serious adverse events after operation of surgical patients cared by these surgeons and anesthesiologists [During hospitalization or within 7 days postoperatively，whichever comes first]
including acute kidney injury, myocardial infarction and stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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