Post Traumatic Stress DisorderNCT05732116
PTSD of Surgeons or Anesthesiologists on Prognosis of Surgical Patients
An observational study of Post Traumatic Stress Disorder and Postoperative Complications, run by Xijing Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Postoperative Complications, COVID-19
- What is being tested?
- PTSD
- How many people
- 356 participants
- Where
- 2 sitesChina
- Study dates
- 21 Feb 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Registered Surgeons and anesthesiologists in the study center
Who cannot join
- Surgeons and anesthesiologists with potential practice location changes during the study periods
- Refuse to sign written informed consent and fill out the evaluation questionnaire
Trial locations and contacts
2 sites in 1 country.
About this study
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
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).
Read the 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.
- Being tested
- PTSD
- Keywords
- COVID-19, Postoperative Complications, Surgery, Post Traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic, Postoperative Complications, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTSDOther
Also called With 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.
| Study group | Role | What they receive |
|---|---|---|
| Exposure: With PTSD | Surgeons or anesthesiologists with PTSD Receives: Other: PTSD | |
| Comparator: Without PTSD | Surgeons or anesthesiologists without PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications of surgical patients cared by these surgeons and anesthesiologists
postoperarive complications of patients whose surgery was performed by surgeons or anesthesiologists who participates in the study
Measured: During hospitalization or within 7 days postoperatively, whichever comes first
Secondary outcomes (5)
postoperative pulmonary complications of surgical patients cared by these surgeons and anesthesiologists
Postoperative pulmonary related adverse events, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis.
Measured: During hospitalization or within 7 days postoperatively, whichever comes first
postoperative length of hospital stay of surgical patients cared by these surgeons and anesthesiologists
the duration between end of surgery to discharge from hospital
Measured: 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
Percentage of patients admission to ICU for which is unexpected before surgery.
Measured: 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
defined as comfirmed death or discharge to hospice.
Measured: 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
including acute kidney injury, myocardial infarction and stroke
Measured: During hospitalization or within 7 days postoperatively，whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start21 Feb 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo No.2 Hospital
- Responsible party
- Principal investigator, Chong Lei, MD & phD, Xijing Hospital
- Investigators
- Chong Lei, MD&phD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732116
- Sponsor's protocol ID
- KY-20230081
- Status last verified
- Aug 2026
- First submitted
- 8 Feb 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05732116
- Acronym / sponsor ID
- KY-20230081
- Keywords
- COVID-19, Postoperative Complications, Surgery, Post Traumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Ningbo No.2 Hospital
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure: With PTSD | – | Other: PTSDSurgeons or anesthesiologists with PTSD |
| Comparator: Without PTSD | – | –Surgeons or anesthesiologists without PTSD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Registered Surgeons and anesthesiologists in the study center
Key exclusion criteria (2 listed)
- Surgeons and anesthesiologists with potential practice location changes during the study periods
- Refuse to sign written informed consent and fill out the evaluation questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTSDAlso: With PTSDSeries 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 | Exposure: With PTSD |
Primary outcome
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
5 secondary outcomes
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 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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chong Lei, MD&phD principal investigator
Xijing Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Traumatic Stress Disorder and Postoperative Complications, run by Xijing Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications of surgical patients cared by these surgeons and anesthesiologists (time frame: During hospitalization or within 7 days postoperatively, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.