NCT05732116

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 21, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

February 8, 2023

Last Update Submit

April 2, 2025

Conditions

Keywords

COVID-19Postoperative ComplicationsSurgeryPost Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    During hospitalization or within 7 days postoperatively, whichever comes first

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Exposure: With PTSD

Surgeons or anesthesiologists with PTSD

Other: PTSD

Comparator: Without PTSD

Surgeons or anesthesiologists without PTSD

Interventions

PTSDOTHER

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.

Also known as: With PTSD
Exposure: With PTSD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Registered Surgeons and anesthesiologists in the study center

You may not qualify if:

  • Surgeons and anesthesiologists with potential practice location changes during the study periods
  • Refuse to sign written informed consent and fill out the evaluation questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ningbo NO.2 hospital

Ningbo, Zhejiang, China

RECRUITING

Xijing Hospital

Xi'an, 710032, China

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticPostoperative ComplicationsCOVID-19

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Chong Lei, MD&phD

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chong Lei, MD, phd

CONTACT

Lini Wang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 16, 2023

Study Start

February 21, 2023

Primary Completion

November 30, 2025

Study Completion

December 31, 2025

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations